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Study Protocol
Kathy Richards, PhD, RN, FAAN, FAASM; Janet Morrison, PhD, RN; Yan-yan Wang, PhD; Angelica Rangel, MS; Ana Loera, BSN, RN; Alexandra Hanlon, PhD; Alicia Lozano, MS; Christine Kovach, PhD, RN, FAAN, FGSA; Nalaka Gooneratne, MD, MSc; Liam Fry, MD, CMD, FACP; Richard Allen, PhD, FAASM
Nighttime agitation is a prevalent symptom in persons with Alzheimer's disease (AD). Effective treatments are absent due to our limited knowledge of its etiology. We hypothesized that restless legs syndrome (RLS), a common neurological sensorimotor disorder of uncomfortable leg sensations that appear at night and interfere with sleep, might be a cause for nighttime agitation in persons with AD. RLS is infrequently identified in persons with AD because traditional diagnosis is dependent on patients answering complex questions about their symptoms. With a validated observational tool for RLS diagnosis, the Behavioral Indicators Test-Restless Legs, we aim to diagnose RLS and determine the effect of gabapentin enacarbil (GEn) compared to placebo on nighttime agitation, sleep, antipsychotic medications, and the mechanism for these effects. We hypothesize that frequency of RLS behaviors will mediate the relationship between GEn and nighttime agitation. This study is an 8-week, double-blind, placebo-controlled, randomized pilot clinical trial, followed by an 8-week open-label trial, that is being conducted in long-term care settings and private homes. The results of this study may shift, personalize, and improve standards of care for treatment of nighttime agitation; reduce aggression and other nighttime agitation behaviors; and improve sleep.
Persons with AD with nighttime agitation potentially caused by RLS.
Diagnose RLS and determine the effect of GEn.
The frequency of RLS behaviors will mediate the relationship between GEn and nighttime agitation.
Determine the effect of GEn on nighttime agitation, sleep, and antipsychotic medications.
ClinicalTrials.gov Identifier: NCT03082755 (Date of registration March 6, 2017). [Research in Gerontological Nursing, 13(6), 280–288.]
In 2020, the direct costs to American society of caring for individuals with Alzheimer's disease (AD) and other dementias will total an estimated $305 billion, and up to 30% of these costs are attributed to the management of neuro-psychiatric symptoms (Alzheimer's Association, 2020). One prevalent neuropsychiatric symptom is agitation late in the day, also called sundowning, defined as emotional distress, loud vocalizations, excessive psychomotor activity, physically aggressive behaviors, disruptive irritability, and disinhibition in the afternoon and/or evening hours (Bachman & Rabins, 2006; Porsteinsson et al., 2014). Nighttime agitation is often associated with sleep disturbances.
Developing effective and sustainable treatments for nighttime agitation in persons with AD is difficult because knowledge of its etiology is limited. Agitation behaviors may be in response to unmet needs that cannot be communicated any other way. The current study focuses on one unmet need, a sleep disorder called restless legs syndrome (RLS) that is infrequently diagnosed or treated in older adults with AD (Richards et al., 2010). Patients with RLS report an urge to move associated with uncomfortable leg sensations that are engendered or worsened by rest or inactivity, relieved by moving the legs, and occur largely in the evening or first part of the night (American Academy of Sleep Medicine, 2014). A relationship between RLS and nighttime agitation is expected, given the nature and etiology of the symptoms (Figure 1), and supported by preliminary work (Rose et al., 2011).
Figure 1.
Circadian rhythms of nighttime agitation and restless legs syndrome (RLS).
Nonpharmacological interventions for treating behavioral symptoms are preferred over medications in older adults because of the potential for adverse medication side effects. Unfortunately, there is insufficient evidence of the efficacy of nonpharmacological interventions for treating RLS. In a survey of eight geriatric and sleep clinicians, five (63%) recommended the alpha 2 delta (α2δ) ligands gabapentin or gabapentin enacarbil (GEn; Horizant®) for treating RLS in frail older adults because of a favorable safety profile and efficacy. The mechanism for the effect of α2δ ligands on RLS is thought to be their effect on pre-synaptic glutamatergic transmission (Gonzalez-Latapi & Malkani, 2019). A growing body of literature links brain iron deficiency, altered glutamatergic transmission, and RLS. Although gabapentin is used off-label for treating RLS, it is not approved by the U.S. Food and Drug Administration (FDA) for this purpose; thus, the study investigative team chose GEn as the intervention for this clinical trial.
The primary study objective is to determine the effect of an FDA-approved drug for RLS, GEn, compared to placebo on nighttime agitation (Aim 1). Secondary objectives are to: describe the safety of GEn compared to placebo in this population (Aim 2); estimate the effect size of GEn compared to placebo on nighttime sleep, RLS behaviors, and post-trial antipsychotic use (Aim 3); and explore whether frequency of RLS behaviors mediates the relationship between GEn and nighttime agitation (Aim 4).
We hypothesize that compared to the placebo control group, the GEn treatment group will have fewer nighttime agitation behaviors, better nighttime sleep, and fewer RLS behaviors, and that frequency of RLS behaviors will mediate the effect of GEn on nighttime agitation behaviors.
GEn is an actively transported prodrug of gabapentin that provides dose-proportional, sustained exposure to gabapentin (Lal et al., 2009). It is absorbed in the gastrointestinal tract by passive diffusion and active transport. GEn is converted to gabapentin after absorption by non-specific carboxylesterases, which are primarily present in enterocytes. The extended-release (ER) formulation allows for sustained delivery of gabapentin to the systemic circulation, thus reducing dosing frequency and producing predictable exposures. The sustained duration of absorption was estimated at 7 hours, with interindividual variability of 22%, and the elimination half-life is approximately 6 hours, similar to the half-life after dosing gabapentin (Lal et al., 2013). GEn is primarily excreted by the kidneys as unchanged drug (Cundy, Annamalai, et al., 2004; Cundy, Branch, et al., 2004; Cundy et al., 2008).
GEn was approved by the FDA in April 2011 for the treatment of moderate-to-severe primary RLS in adults (U.S. FDA, 2012). Clinical trials have demonstrated a safety profile comparable to traditional gabapentin, improved pharmacokinetics, and significant differences when compared to placebo on RLS symptoms, subjective sleep quality, and wake at night (Yaltho & Ondo, 2010). For example, a 2012 review and meta-analysis graded the evidence as high for the effectiveness of GEn for moderate to severe RLS (Aurora et al., 2012). Arbor© Pharmaceuticals LLC markets GEn (Horizant®) and provides GEn 300 mg ER tablets free of charge for participants during the research.
The study is a pilot, 8-week, double-blind, placebo-controlled, randomized clinical trial of GEn versus placebo, and an 8-week open-label post-trial follow up to assess continued RLS treatment and antipsychotic use. The trial control condition is matching placebo because there currently are no FDA–approved medications for nighttime agitation, and few nonpharmacological interventions for nighttime agitation have been empirically tested. As described in the Clinical Antipsychotic Trials of Intervention Effectiveness–AD, the proposed trial design encourages prescribing that reflects clinical practice while maintaining the randomized and double-blind treatment assignment (Schneider et al., 2006). We anticipate a sample size of 136; 68 per treatment arm, drawn from approximately 30 sites.
A study statistician, not involved in the study data analysis, developed the randomization schema, by site, by A or B group allocation. Randomization was performed as block randomization with a 1:1 allocation. The statistician sent the schema to the study research pharmacist, who designated whether the A or B group was the GEn or placebo condition. After the study medical team confirms that all eligibility criteria have been met, the study physician or her designee (MD, nurse practitioner, or physician's assistant) writes the order, dosage, and time of administration for the study drug: (a) in each participant's medical record for those residing in long-term care (LTC) facilities or (b) on a standard prescription form. Trained project staff assign participants the next sequential identification number for the LTC facility or community-based setting where they reside and notify the research pharmacist of the participant's identification number. The pharmacist consults the randomization schema to determine whether the participant gets GEn or placebo and dispenses either GEn or placebo based on the schema.
Participants randomized to the control condition receive tablets identical to GEn, but inactive. The tablets match GEn in texture, color, size, thickness, markings, smell, and packaging.
In this double-blind study, the condition is unknown to participants, investigators, and the entire study team, and those who administer the medication. The research pharmacist, who fills the prescriptions, is unblinded to condition. It is possible that the study RN, LTC staff, or home caregivers may notice improvement or side effects in the GEn group, and suspect treatment assignment. The raters of the primary outcome are not involved in assessments for improvement or adverse events and results will not be communicated to them. Separation of raters from clinical care will minimize the possibility that rating of the primary outcome will be biased. Unblinding will occur when data collection and entry are complete.
Project staff collect data from eligible persons living in LTC facilities and independent living settings (i.e., senior independent living apartments and private homes in the community) over approximately 4 years. Based on our prior research (Richards et al., 2011) and current recruitment efforts, we expect that 450 referrals will be required, approximately 55% of those referred will consent (n = 247), and approximately 57% of those consented will qualify for randomization. Attrition after randomization due to death or hospitalization and other reasons is expected to be 15% (Richards et al., 2011). Enlisting approximately 25 LTC facilities and five independent living settings should provide the required sample of 136, but if needed, additional facilities and persons living independently will be recruited.
Power is based on the single primary outcome, nighttime agitation, as measured by the Agitation Behaviors Index (Rose et al., 2011) observed over 8 weeks, and a type I error rate of 0.05. Assuming a mean Agitation Behaviors Index of 1.5 (SD = 0.90) in both groups (Rose et al., 2011) at baseline, a within-subject variance of 1.6, and an autocorrelation equal to 0.81, and that the control and treatment groups demonstrate mean values of 1.35 (10% placebo effect) and 1.0 at 8 weeks, respectively, 68 participants per group will achieve >90% power to detect a minimum detectable difference of 0.25 for changes in nighttime agitation over time between the two treatment arms (interaction term in mixed model group × time).
Study inclusion and exclusion criteria and justification are presented in Table A (available in the online version of this article). Overall, the inclusion/exclusion criteria, study design, and data analysis methods reflect our efforts to reduce measurement "noise" (i.e., random fluctuations that hinder detection of true differences, if they exist). The criteria for inclusion/exclusion were also selected to maximize our chances of recruiting and retaining the sample and reduce the potential for risk. For example, inclusion requires a level of observed agitation to avoid a "floor effect," but avoids including only individuals who are highly agitated to allow a sufficient recruitment pool. Observations for agitation occur on more than one night and at different times of the night to increase our chances of detecting nighttime agitation, given the circadian and night-to-night variability that often occurs. Persons with AD frequently cannot reliably report their symptoms; thus, in this trial, RLS is diagnosed using a validated tool designed for this population. An example of an exclusion criterion to reduce the potential for participant risk is excluding those who consume alcohol because consuming GEn and alcohol together may increase sedation. Fidelity of all measures, including those specifically used for inclusion/exclusion, is addressed by extensive training and testing of project staff, ongoing monitoring of data by the investigators, and assessments of interrater reliability during the study.
Table A:
Inclusion and Exclusion Criteria with Rationale
Age, appropriateness of medication for agitation, ability to swallow medication, and other inclusion/exclusion data are collected by the study RN from the medical records, participants' physicians, caregivers, LTC staff, and assessment. AD diagnosis is determined by either physician diagnosis recorded in the medical record or made by the study physician co-investigator (L.F.) or her designee (nurse practitioner or physician's assistant) (McKhann et al., 2011). Descriptions of the inclusion and exclusion screening measures are in Table B (available in the online version of this article).
Table B:
Study Variables and Description of Measures
Prescribing of the study medication, dosage, and monitoring of response are performed by one or more members of the study medical team using an online meeting, desktop sharing, and videoconferencing software package. The medical team consists of the co-investigators (a geriatrician [MD; L.F.]; two sleep medicine specialists [MD, N.G.; PhD, R.A.]), the study head nurse (BSN, RN; A.L.), and the study principal investigator (PhD, RN; K.R.).
LTC facility staff or home caregivers administer GEn/placebo. The starting dose is one tablet of 300 mg GEn or placebo with food by mouth nightly at 5 p.m. The medical team reviews the participant's response after he/she has been on the study for 2 weeks. They then determine if the patient should continue, or whether the dose should remain at one tablet or increase to two tablets. The dosage increase is based on the creatinine clearance (CC) using GEn prescribing guidelines: CC ≥60 for 600 mg daily and CC 30 to 59 for 300 mg daily (U.S. FDA, 2012) and participant response to the study drug. An example of how the medical team evaluates participant response is review of falls data. All falls during the trial, and their proximity to receiving the study drug and other medications, and their presumed causes are recorded and compared with any history of falls. The falls comparisons, other clinical information (e.g., reports of increased daytime napping), and their clinical judgment guide the team on whether to increase dosage or discontinue GEn/placebo.
Duration for clinical trials on GEn generally range from 2 to 64 weeks, with most approximately 12 weeks (Garcia-Borreguero et al., 2012; VanMeter et al., 2012). A therapeutic response with reduced discomfort and improved sleep occurs in as little as 2 weeks. An 8-week trial will provide more than adequate duration to achieve a therapeutic response and assess safety outcomes.
At the end of Week 9, the study drug is discontinued for all participants. GEn administration guidelines for stopping the drug specify that there is no need to gradually taper the medication if dosage is ≤600 mg, but our team takes a more conservative approach at the end of the 8-week clinical trial period by reducing the dose to 300 mg for 1 week (Week 9) prior to discontinuing.
The study RN closely monitors for known GEn side effects (e.g., increased dizziness, somnolence/sedation, weight change ±5%), and other potential effects, such as decreased mobility, defined as a >4-point change on the Pike and Landers (2010) Physical Mobility Scale. In a double-blind, placebo-controlled study in 325 participants, somnolence and dizziness were the most common adverse events (Lee et al., 2011). Somnolence occurred in 21.7% at the 600-mg dose (2.1% placebo), with a median (range) duration of 35 (1 to 85) days, which led to discontinuation in three participants. Dizziness occurred in 10.4% at the 600-mg dose (5.2% placebo), with a median duration of 5 days, which led to discontinuation in two participants.
All adverse events and serious adverse events are reported by the study RN and reviewed by the medical team for expectedness, relationship to participation in the study, and the potential that the research may place participants at risk for harm. For a given trial participant, the study intervention may be discontinued by the investigators and protections initiated if harms develop that may reasonably be linked to the study drug, such as: (1) suicidal ideation or behavior—immediately report to participant's physician, caregiver, and/or LTC staff to institute suicide precautions and discontinue study drug (no taper required); (2) drug reaction with eosinophilia and systemic symptoms syndrome—immediate evaluation by participant's physician and discontinue study drug if alternative etiology is not identified (no taper required); and (3) somnolence/sedation—reduce dosage or discontinue study drug (no taper required).
The study RN oversees the study intervention. Because changes in medications during the study may confound results, she requests that providers not change current medications and nonpharmacological interventions during the 8-week clinical trial, and she monitors and records any medication or dosage changes that occur. The study RN also monitors administration of the study drug. She visits the facility and participants living at home three times per week for Weeks 1 and 2, and weekly for Weeks 3 through 8. During these visits, she checks the medication administration records and the individual dose packages for any missed doses, documents any missed doses, and resolves any reasons doses were missed.
When participants complete the clinical trial, the medical team reviews their outcome data and develops tailored recommendations for treating RLS. Recommendations typically include tapering and discontinuing any medications known to exacerbate RLS, such as selective serotonin reuptake inhibitors; oral iron for those with iron deficiency; and continued treatment with GEn. The study RN shares the treatment plans with each participant's provider. At the end of the 8-week open-label trial, the study RN records adverse events, medications (to determine if providers followed the treatment recommendations), and specifically notes any new or continued use of antipsychotics for management of nighttime agitation.
In this study, we will determine if identifying RLS, using a new dementia-specific diagnostic tool that we validated, and treating RLS using a FDA–approved medication, reduces or eliminates nighttime agitation, improves sleep, reduces RLS behaviors, and ultimately reduces the use of antipsychotic medications. The study outcome measures were chosen because (a) we expect that participants will show impairment on the measures at baseline; (b) they are less likely than other measures we considered to have floor or ceiling effects; (c) they have been shown to improve after treatment; and (d) when possible, they provide cross verification of the findings because data are collected from multiple sources.
Various data and measures are collected to screen participants for inclusion and describe participants. Project staff collect a number of descriptive measures, such as age, sex, race, and ethnicity; setting; medical history; and mobility requirements. Because RLS is often associated with iron deficiency, project staff collect blood for a complete blood count with differential and an iron panel at baseline.
Project staff work closely with LTC facility staff and primary home caregivers to train them on the study protocol, specifically on the study measures, using study-specific written materials and one-on-one interactions. Originally, the investigators had planned an orientation session on each shift for the LTC staff, but feedback from staff and administrators was that the orientation session was not needed because staff involvement in data collection is minimal. Table B describes the study variables and measures, and Table C (available in the online version of this article) lists the assessments, and other study activities, and when the study staff collect the various data.
Table C:
Study Schema
Recruitment and Retention. Project staff recruit eligible persons living in LTC facilities and independent living settings. One of the study co-investigators (L.F.), a geriatrician and medical director of several LTC settings, often facilitates the recruitment process by introducing the project team to colleagues and explaining the research to local and corporate LTC facility administrators. Project staff recruit participants living independently by distributing recruitment materials or speaking on topics of interest at non-profit senior organizations, senior-living complexes, and adult daycare programs. Recruitment of minorities is a high priority. Project staff identify LTC facilities, independent living communities, and physician practices with high percentages of minorities and encourage them to support the research. Project staff contact caregivers of potential participants residing in independent living settings who express interest, and nursing or medical staff at the LTC facilities identify potential participants. Strategies to promote retention of study participants include ongoing open communication with participants and their families, and individualized attention for participants (and the home caregivers for those residing in independent living settings) during the study visits.
Informed Consent. Prior to beginning the research, ethical approval was obtained from the Institutional Review Board (IRB) at The University of Texas at Austin. Project staff explain the purpose, risks, potential benefits, requirements, and alternatives to potential participants and their legally authorized representatives. They explain all study procedures including administration of the GEn/placebo, cognitive testing, drawing blood, and measuring nighttime agitation and sleep. In addition, potential study risks, such as dizziness, are described. Participants, their relatives, and authorized representatives are given the opportunity to inquire about details of the study. Project staff administer the MacArthur Competence Assessment Tool for Clinical Research (Appelbaum & Grisso, 2001) to potential participants and their legally authorized representatives to assess their competency to give consent. If the authorized representative and the potential participant are unable to give consent, they are thanked for their time and no further data are collected. After all explanations are given and all questions answered, the project staff obtain written informed consent from the patient and/or the authorized representative.
Compensation. Participants are not compensated monetarily for the research. However, those who complete the trial receive a 1-hour social activity session provided by project staff, the resident's favorite refreshments, and a framed certificate. Caregivers of participants living in the community receive compensation in appreciation for their time. Caregivers receive up to four payments totaling $300: $50 after baseline, $75 after 2-week, $125 after 8-week, and $50 after 16-week assessments.
Modifications to the Study Protocol. The investigators made several modifications to the study protocol to improve recruitment, reach sample size goals, and maximize participant safety. All modifications are initiated by the study investigators, approved by the IRB, and reviewed by the Data Safety Monitoring Board (DSMB). Table D (available in the online version of this article) describes each modification and rationale.
Table D:
Protocol Modifications
A 25% improvement in nighttime agitation, the primary study outcome, would represent a clinically significant benefit for patients (Cohen-Mansfield et al., 2007). Estimates are based on computations from 100 simulations for an intent-to-treat mixed effects model of repeated measures over time (two observations at each of the three time points: baseline, 2 weeks, and 8 weeks). Other outcomes (i.e., safety, nighttime sleep, RLS behaviors, and antipsychotic medications) will be considered as exploratory pilot data to inform a larger, more definitive trial. Details of all study outcomes, including variable type and data collection timepoints, are provided in Table B and Table C. The comprehensive statistical analysis used for the primary outcome will rely on mixed effects modeling. For specific details of all statistical analyses, please refer to Table E (available in the online version of this article). Analyses will be performed using SAS V9.4.
Table E:
Methods of Analysis
Data are collected and entered in real-time into a study-specific Research Electronic Data Capture (REDCap) database portal. REDCap is a secure web-based application for building and managing online databases. Data input occurs over a secure web connection with authentication and data logging in a regulation-compliant environment. The project staff uses online study-specific REDCap forms to collect and enter data using tablets and laptop computers. The Data Management Committee, led by the study's database consultant (software systems engineer), developed and designed the study database. Data collection forms were created and organized within 14 REDCap projects based on study design. Project staff initially pilot tested the data collection system with project staff as "participants" in the LTC settings and private homes to identify and resolve connectivity, equipment specifications, and optimal camera and research staff placements. Participant data are monitored for completeness and accuracy by project staff and reviewed by the medical team and research coordinator at baseline, 2, 8, and 16 weeks.
A DSMB was established to act in an advisory capacity and monitor participant safety, data quality, and evaluate the progress of the study. The DSMB comprises five members, who have no conflicts of interest with the trial and are not collaborators or associates of the investigators, and a safety officer. The study nurse and medical team evaluate a reported event with the standard classifications of severity, outcome, and likelihood it was caused by the study drug. Safety assessments determine if the adverse event is serious or non-serious; its intensity, severity, duration, episodic nature, and outcome of the adverse event; and the relationship of the adverse event to the drug. During the study recruitment period, adverse events are analyzed by the unblinded study statistician by A and B groups and reviewed by the DSMB in closed session. Reports containing recommendations, including whether to continue or terminate the study, are sent to the principal investigator and National Institutes of Health program officer after each meeting.
Two prevalent and difficult to manage symptoms in persons with AD are nighttime agitation behaviors, such as wandering and aggression, and sleep disturbances. Multiple interrelated factors, such as frailty, immobility, and cognitive impairment, make the management of these symptoms challenging. There are currently no FDA– approved medications for treatment of nighttime agitation. Nighttime agitation and sleep disturbance are associated with more rapid cognitive decline, falls, wandering from home, institutionalization, and caregiver burden.
The treatment of comorbidities or deprescribing of medications that exacerbate nighttime agitation and sleep disturbances should always be the first step. Our study is the first randomized controlled trial to focus on treatment of a common comorbid condition, RLS, to determine if RLS diagnosis and treatment affects nighttime agitation and improves sleep in older adults with AD. The trial will also provide evidence on the safety profile of a FDA– approved drug for treatment of RLS, GEn, in older adults with AD.
This study is highly innovative because it is the first to (a) concurrently address three comorbid chronic conditions in persons with moderate to severe AD: nighttime agitation, sleep disturbances, and RLS; (b) use a precision medicine approach to individually tailor treatment for nighttime agitation to a neglected and unrecognized potential cause (i.e., RLS); (c) use a new and innovative standardized diagnostic tool that we developed to identify RLS in persons who cannot verbally report their RLS symptoms; (d) examine whether frequency of RLS behaviors is a mechanism for nighttime agitation; and (e) apply real-time observational techniques that we developed to precisely measure nighttime agitation. This project is relevant to public health because the results may provide an alternative to antipsychotics and sedative-hypnotics for treatment of nighttime agitation and sleep disturbances in persons with AD.
Dr. Richards is Senior Research Scientist, Dr. Morrison is Research Associate, Dr. Wang is Research Associate, Ms. Rangel is Research Associate, and Ms. Loera is Staff Nurse, The University of Texas at Austin, School of Nursing, Austin, Texas; Dr. Hanlon is Director and Ms. Lozano is Assistant Director, Center for Biostatistics and Health Data Science, Virginia Tech, Department of Statistics, Roanoke, Virginia; Dr. Kovach is Director of Research, Jewish Home and Care Center, Ovation Communities, Milwaukee, Wisconsin; Dr. Gooneratne is Associate Professor of Medicine, Geriatrics Division, Perelman School of Medicine, University of Pennsylvania, Center for Sleep and Circadian Neurobiology, Philadelphia, Pennsylvania; Dr. Fry is Chief, Division of Geriatrics and Palliative Care, and Assistant Professor, Department of Internal Medicine, The University of Texas at Austin, Dell Medical School, Austin, Texas; and Dr. Allen is Professor of Neurology, Johns Hopkins School of Medicine, Department of Neurology and Neurosurgery, Baltimore, Maryland.
The authors have disclosed no potential conflicts of interest, financial or otherwise. The authors acknowledge funding support from the National Institute on Aging of the National Institutes of Health (R01AG051588); and Arbor Pharmaceuticals for gabapentin enacarbil and matching placebo.
Dr. Kovach was not involved in the peer review or decision making of this manuscript.
The authors also thank the long-term care facilities in Austin, Texas, and study participants and their families.
Address correspondence to Kathy Richards, PhD, RN, FAAN, FAASM, Senior Research Scientist, The University of Texas at Austin, School of Nursing, 155 Waterfront Drive, Montgomery, TX 77356; email:
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Dating apps and dating sites are the new norm, with 48 percent of 18 to year-olds, 38 percent of 30 to year-olds, and 16 percent of.
Jump to navigation. It's fair to say that once you start dating in your 40s, you're almost certainly taking the search for love seriously. And there's nothing wrong with that! Meeting and falling in love with a supportive, mature partner is a worthy priority in your life; the only problem is how to find them. It's becoming such an essential tool for dating in your 40s – allowing compatible single men and women to connect directly – all you have to decide is which site suits you best Over 40 dating sites aren't in short supply, so it's important to find the one that works best for you.
EliteSingles prides itself on the fact that our members are both successful and well-educated, as well as serious about their search for long-lasting love. If that sounds like you, you're in the right place! The average age of our US members is 44, which not only makes us a great place to start your own over 40 dating story but also means that we're designed to serve mature members.
An inclusive site, catering for singles from every walk of life – from Christian singles to divorcees , LGBT singles to single parents – we rely on our intelligent matchmaking system to find potential partners who are perfect for you.
11 best online dating sites and apps, according to the experts
Your hand-picked selection of the best online dating sites to try, plus how to stay safe online dating and have a successful first date. Advice for everyone Now its about as normal as Internet banking just way more fun. Wondering why you should opt for one of the best online dating sites, not an alternative or more traditional approach? E-harmony and Imperial College business school research found that by , more babies will be born to parents who met online than offline.
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48 year old woman dating a 60 year old man – Join the leader in rapport services According to the online-dating site that if you're going through old vietnamese Women who don't hit menopause the good for a relationship with a faster, .
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Providence Service Debuts, Closes 17% Above IPO Price
NEW YORK -- After delaying its IPO last week due to regulatory issues, Providence Service Corp. began initial trading Tuesday, rising in its debut.
Providence Service, a social-services company based in Tucson, Ariz., rose to $14 in 4 p.m. Nasdaq Stock Market trading, 17% above its $12 offering price. Pricing of the initial public offering of 4.3 million shares was at the high end of estimates of $10 to $12 a share.
SunTrust Banks Inc.'s SunTrust Robinson Humphrey and Jefferies & Co. led the IPO. Providence Service provides personnel for social-service programs. It is a business that is growing as states struggle with their own budget crises, said Providence Chief Executive Fletcher McCusker. "The states are under a lot of pressure," he said.
The business is concentrated largely in the Southeast, Southwest and the Midwest, where states have privatized their social-service programs. Unlike some businesses built around privatization of government programs, Providence doesn't push states to move in that direction, Mr. McCusker said. "We're not trying to make legislative changes," he said. "There's not a single lobbyist who works for our company."
The business is profitable. Last year, it reported $945,000 in net income. For the first six months of this year, it reported net income of $1.1 million, up from $595,000 for the same period a year earlier.
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TheUniversity of Eastern Finland is granting tuition fee waiver scholarships for international students. A generous scholarship plan covers the tuition fee either completely or partly for students who are needed to pay tuition.
TheMaster's Degree Programme in Information Technology (IMPIT) provides an international Master's degree in IT at European requirements in 2 years. The goal is that many students are utilized by a Finnish ICT business when they finish.
TheUniversity of Eastern Finland is a university in Finland with 3 schools in Joensuu, Kuopio, andSavonlinna It was formed in 2010 by a merger of 2 formerly independent universities.
Applications close: January 31, 2018
CourseLevel: Scholarships are readily available for pursuing master's degree program.
StudySubject: Scholarships are granted in the field of Information Technology (IMPIT).
ScholarshipAward: Either 100% or 80% of yearly tuition
Numberof Scholarships: Waiver is provided to 80% of those accepted students who are needed to pay the tuition.
Scholarship can be taken inFinland
Eligibilityfor the Scholarship:
EligibleCountries: International students (other than EU/EEA) can use.
- Students who are needed to pay the tuition fee.
- BSc. degree in Computer Science, Information Technology, Communications Engineering or comparable degree corresponding at least 3 years of full-time college scholastic research studies.
EnglishLanguage Requirements:
- TOEFL PBT/iBT: 580/90, IELTS general 6.5, PTE: 59
- TOEFL, IELTS and PTE certificates stand for 2 years from the day they are released and they need to stand throughout the whole application duration.
Eachapplication need to consist of the following files
- Official records of university records from the house university in English, or a formally accredited translation of it.
- A licensed copy of BSc. diploma or equivalent (OR a declaration of anticipated graduation, if the BSc degree has actually not been finished yet, OR a provisionary BSc certificate)
- Motivation letter
- An initial video file of a candidate submitted into a video-streaming service such as youtube/vimeo/tudou. Link (URL) to the video needs to be consisted of into the application type. The optimum period of a video is 2 minutes. The video need to consist of the intro, academic background and possible benefits of the candidate. The video need to be obtainable from 31.1.2018– 31.3.2018
- Letterof suggestion from a regional scholastic authority, ideally understood to the UEF
- Generally acknowledged English language certificate sent by mail straight from the test administrator (in case of IELTS, likewise a copy of the outcome sheet is accepted) OR a certificate mentioning language abilities, if one of the particular conditions for language abilities is satisfied (discussed at the bottom of this page)
- Passport copy/other files of recognition
- Optionally, an example of a connect to own specific operate in English (term paper, report, essay, art, literature evaluation, recorded software application, and comparable). This must be equated into English or Finnish.
How to Apply:
Upon using for admission to the program (a different area in an admission type)
- Make sure that you satisfy the admission requirements and have actually all the needed files informed
- Fill out the application type in an online application system and connect the needed enclosures.
- Send all the needed files to IMPIT program, University of Eastern Finland, Admissions Office.


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This website is home to the latest news in print, updated daily for quick print professionals. Please subscribe to the newsletter...
This website is home to the latest news in print, updated daily for quick print professionals. Please subscribe to the newsletter...
Doing Their Bit
The Sharp MX-1800N - a full colour multifunctional printer (MFP) - delivers professional finishing and high productivity for the environmentally-focused small and mid-sized businesses market.The new model has an output speed of 18ppm for both colour and black and white and delivers high quality imaging and networking printing and scanning functions for documents up to A3 in size.To satisfy demand for increased control over the cost and usage of colour MFPs to reduce environmental impact and boost productivity, the MX-1800 has energy-saving features such as low toner consumption and a long-life photoconductor. Its environmentally conscious design features productive black and white output and low colour usage - effectively replacing existing inkjet or laser printers.The MX range features smaller and more cost efficient toner cartridges and Sharp has developed its technology to ensure that a mono cost per print is equivalent to that of conventional mono devices. Cartridges are made from recyclable plastic and there is also substantially less
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Automatically generating notes from spoken language
Jobs at Kiroku
Kiroku is creating technologies which automate the least rewarding parts of work. They have built novel technology which listens to a conversation between a dentist and a patient during a dental appointment and automatically generates the clinical notes. Kiroku believes that speech to text is not enough, and the next step is speech to meaning. The same technology is used to automate other admin tasks such as referral letters and it has the potential to be applied to other professional fields. We are backed by some of the biggest names in both the startup and NLP ecosystems. We are growing fast so even if we have no advertised role that fits you please still get in touch!
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Software Engineer (Front-end)
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An Update on the Cricket Classic
Dear Families,
Thank you to those who have expressed concern about the measures in place to keep everyone as safe as possible during our Cricket Classic. We gave the matter considerable thought in planning the event and had hoped that those protocols would be sufficient to keep both players and spectators safe.
It is with sadness that we announce that, in light of the surge in COVID-19 across the Metroplex, the recent cases at our own Upper School, and following guidance from regional health authorities, it is necessary for us to postpone our second annual Cricket Classic until further notice.
We know many in our community were looking forward to this event, and we hope to be able to reschedule it for sometime in the spring.
A special thank you to our sponsor, State Bank of Texas, and our teacher and parent players. This just means that our teachers will have more time to practice bowling, batting, and fielding and be able to put up a better fight against our very talented, cricket-loving parents when we are able to hold the match safely.
Great Hearts Irving Lower School


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Nov 23, 2020
(09 Rabi Al-Akhar 1442) Bolans Prayer Times Today are calculated as Fajr Time 5:01 AM, Dhuhr Time 11:54 AM, Asr Time 3:08 PM, Maghrib Time 5:32 PM & Isha Time 6:43 PM. Get accurate Bolans namaz & salah times with 7 days and 30 days timetable of Bolans prayer timing.
* All Timings are Beginning Times
Narrated Anas: Once the Iqama was pronounced and the Prophet was talking to a man (in a low voice) in a corner of the mosque and he did not lead the prayer till (some of) the people had slept (dozed in a sitting posture) .
Bolans Prayer Times - Today 24 Nov 2020 Bolans Namaz Timings are Fajr 5:01 AM, Dhuhr 11:54 AM, Asr 3:08 PM, Maghrib 5:32 PM & Isha 6:43 PM. Find Azan and Salat Schedule & 7 Days Timetable. Daily Fajar (Fajr) timing in Bolans, Dhuhur, Asr time in Bolans, Maghrib Bolans prayer times & Isha Bolans Namaz timing. Today's 09 Rabi Al-Akhar 1442 Bolans Namaaz ke auqat (Awqat) with next 7 days Schedule from 24 Nov, 2020 to 30 Nov, 2020 and Qibla direction with Customizable Prayer Time Calculation Methods to calculate proper time for your Namaz.
You may also find here makrooh time updates including
zawal time with complete details start and end time.
Sun Set time that is also called Iftar Time in
and Dawn break Time that is also end of Sehri Time in
5:00 AM. Sehri and Iftar time is also called Ramadan Time during the month of Ramadan.
Today Namaz Timings in Bolans are as follow:
Fajr Time in Bolans - 5:01 AM
Sunrise Time in Bolans - 6:17 AM
Zuhr Time in Bolans - 11:54 AM
Asr Time in Bolans - 3:08 PM
Maghrib Time in Bolans - 5:32 PM
Isha Time in Bolans - 6:43 PM
It consists of 4 Rakat: 2 Farz and 2 Sunnat. Fajr time begins at the dawn time 5:01 AM and remains until the sun rises. Today Fajr time in Bolans ends at sunrise 6:17 AM.
Ishraq Namaz Timing in Bolans today begins at 06:32 AM and the end time is 09:05 AM.
It consists of 12 Rakat: 4 Sunnat, 4 Farz, 2 Sunnat, and 2 Nafl. Zuhr time begins after zawal time ends at 11:54 AM and ends before asr time in Bolans starts at 3:08 PM.
It's an afternoon prayer consist of 8 Rakat: 4 Sunnat and 4 Farz. Today Asr time begins at 3:08 PM and ends before Magrib time in Bolans starts at 5:32 PM.
It's a sunset prayer consist of 7 Rakat: 3 Farz, 2 Sunnat, and 2 Nafl. Today Magrib time begins at 5:32 PM and ends before Isha time in Bolans starts at 6:43 PM.
It's a night prayer consist of 17 Rakat: 4 Sunnat, 4 Farz, 2 Sunnat, 2 Nafl, 3 Witr, and 2 Nafl. Today Isha time begins at 6:43 PM and ends before Fajr time in Bolans starts at 5:01 AM.


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Sketch Fest #126 will run November 20-22! (Today's date: 2020-11-23 22:39:10)
Sketch Fest has ended! Stay tuned for the next event!
Hourglassby Bonnie Byrd
Prompt: Hourglass
4X6 graphite sketch. Hope you enjoy.
Mayumi Ogihara says: Great idea to use a clock face on the top! Thank you so much for using my prompt! ~ Reply?
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Tunisia, Qatar report new virus cases, deaths
Total number of cases in Tunisia crosses 58,000, Qatar has so far reported 132,343 cases
Tunisia and Qatar have reported new coronavirus cases and deaths, local health authorities said on Friday.
In Tunisia, the Ministry of Health stated in a statement that it had recorded 100 new deaths and 3,751 more cases from Oct. 27 to Oct. 29.
Without disclosing the number of recoveries, the ministry said the total number of cases rose to 58,029, while the death toll reached 1,253.
In Qatar, the Health Ministry reported one more death and 193 cases of the virus over the past 24 hours.
The ministry said the total number of cases rose to 132,343, including 232 deaths and 129,349 recoveries.
*Writing by Mahmoud BarakatAnadolu Agency website contains only a portion of the news stories offered to subscribers in the AA News Broadcasting System (HAS), and in summarized form. Please contact us for subscription options.