Donepezil for Dementia
(δND Trial)
Recruiting in Palo Alto (17 mi)
Age: 65+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The University of Texas Health Science Center at San Antonio
Must be taking: Donepezil
Must not be taking: Opiates, Muscle relaxants, Steroids
Disqualifiers: Psychosis, Parkinson's, Cancer, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?The goal of this clinical trial is to demonstrate potential improvements in clinical trial methods relating to dementia and cognitive decline. The main questions it aims to answer are:
* Can an intervention's outcome be better assessed by a latent variable ("δ") integrating cognitive performance with functional status?
* Can latent biomarkers of δ guide the selection of an intervention that will modulate dementia severity?
* Can a latent variable, derived from information collected remotely from caregivers, preselect subjects most likely to respond to the intervention?
* Is the effect of the intervention in fact medicated by changes in the targeted biomarker?
In this case, the biomarker will be a latent variable derived from several proteins measured in blood (i.e., so-called "adipokines"). The intervention will be donepezil, a medication approved for the treatment of Alzheimer's Disease, but only recently associated with adipokine changes.
Participants with cognitive impairment and their caregivers will be interviewed by telephone and those newly prescribed donepezil by their provider for cognitive impairment will be recruited and enrolled. On the basis of the caregiver's report, the cognitively impaired subjects will be assigned to two groups based on a prediction of their response to donepezil. Researchers will compare those groups to see if dementia severity, as measured by δ, improves in predicted responders, and whether the change in the d-score is mediated by changes in adipokines.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking donepezil or any other similar medications, or if you are on opiates, muscle relaxants, or systemic steroids.
What data supports the effectiveness of the drug Donepezil for dementia?
Research shows that Donepezil, also known as Aricept, helps improve thinking and overall function in people with Alzheimer's disease, a common type of dementia. Studies have found that it can be effective for people with mild to moderate Alzheimer's, improving their cognitive abilities and quality of life.
12345Is donepezil generally safe for humans?
Donepezil has been studied for safety in people with Alzheimer's disease, and while it is generally considered safe, some people may experience side effects that can lead to stopping the treatment.
13467How is the drug Donepezil unique in treating dementia?
Donepezil is unique because it is a selective acetylcholinesterase inhibitor, which means it helps increase levels of a chemical called acetylcholine in the brain, improving memory and thinking in Alzheimer's patients. It is taken once daily due to its long half-life, and it was the first drug of its kind to be marketed for Alzheimer's in the UK.
12348Eligibility Criteria
This trial is for people aged 65-100 with Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI), who can walk, have someone to report on their condition, and can consent to the study. They shouldn't be severely depressed or have major hearing/visual issues. Those already on certain dementia drugs, with recent major surgery, depression diagnosis, heart rhythm problems, cancer treatment within 5 years (except skin cancer), psychosis history, Parkinson's disease or related disorders are excluded.Inclusion Criteria
My cognitive function score is between 0.0 and -1.0, compared to a standard group.
I can move around on my own and have someone who knows my health condition well.
I understand the details of the clinical trial and can consent to participate.
+5 more
Exclusion Criteria
I have or have been treated for Parkinson's, tremor, or REM behavior disorder.
I have been treated for or have a history of atrial fibrillation.
I have had psychosis or seen things that weren't there.
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (telephone)
Treatment
Participants receive donepezil, with effects on dementia severity measured by δ and adipokines
24 weeks
Baseline, weeks 4, 12, and 24 (telephone)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The trial tests if donepezil affects a new measure called 'δ' that combines cognitive performance and functional status in dementia patients. It also looks at whether changes in blood proteins ('adipokines') relate to how well donepezil works. Participants will take donepezil for six months while researchers track δ scores and adipokine levels.
2Treatment groups
Experimental Treatment
Group I: Predicted RespondersExperimental Treatment1 Intervention
Group assignment determined by a response predictor algorithm derived from remotely acquired caregiver reports of cognitive performance. The donepezil administered during the study is prescribed by the subject provider as standard of care.
Group II: Predicted Non-RespondersExperimental Treatment1 Intervention
Group assignment determined by a response predictor algorithm derived from remotely acquired caregiver reports of cognitive performance. The donepezil administered during the study is prescribed by the subject provider as standard of care.
Donepezil is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Aricept for:
- Alzheimer's disease
🇺🇸 Approved in United States as Aricept for:
- Alzheimer's disease
- Mild to moderate dementia of the Alzheimer's type
🇨🇦 Approved in Canada as Aricept for:
- Alzheimer's disease
🇯🇵 Approved in Japan as Aricept for:
- Alzheimer's disease
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Univeristy of Texas Health Science Center at San Antonio (UTHSCSA)San Antonio, TX
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Who Is Running the Clinical Trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
National Institute on Aging (NIA)Collaborator
References
Donepezil improves cognition and global function in Alzheimer disease: a 15-week, double-blind, placebo-controlled study. Donepezil Study Group. [2022]Donepezil hydrochloride (Aricept) is a selective acetylcholinesterase inhibitor developed for the treatment of Alzheimer disease. This phase 3 study was 1 of 2 pivotal trials undertaken to establish the efficacy and safety of using donepezil in patients with mild to moderately severe Alzheimer disease.
Open-label, multicenter, phase 3 extension study of the safety and efficacy of donepezil in patients with Alzheimer disease. [2022]Donepezil hydrochloride is a selective acetylcholinesterase inhibitor approved for the symptomatic treatment of mild to moderately severe Alzheimer disease (AD). Controlled clinical trials of up to 24 weeks have demonstrated that donepezil treatment (5 and 10 mg/d) significantly improves cognition and global function.
A 24-week, double-blind, placebo-controlled trial of donepezil in patients with Down syndrome and Alzheimer's disease--pilot study. [2019]Donepezil Hydrochloride (Aricept) is a selective anticholinesterase inhibitor developed for the treatment of Alzheimer's disease (AD). This study investigated the safety and efficacy of the drug to treat Down syndrome (DS) adults with mild to moderate AD.
Use of donepezil in elderly patients with Alzheimer's disease--a Hawaii based study. [2022]Donepezil (Aricept) is a reversible acetylcholinesterase inhibitor which is indicated for the treatment of mild to moderate dementia of the Alzheimer's type. We did a retrospective analysis of 41 elderly Alzheimer's subjects of different ethnic groups including a large number of Asian and Hawaiian patients. Donepezil appears to be clinically effective in patients of different ethnicities with mild to moderate Alzheimer's disease, even at advanced age.
Clinical experience with Donepezil (Aricept) in the UK. [2019]Experience of the use of Donepezil (Aricept) in the UK since licensing is discussed. The results of a 30 week double blind parallel group study in the US of Donepezil 5 or 10 mg versus placebo show statistically significant improvements in cognitive and clinical global assessments. Beneficial effects were demonstrated in the absence of significant adverse effects on physical or laboratory values. The guidelines for use adopted in the UK are discussed with the emphasis on identifying non-cognitive behaviours, as significant improvements in these have been found and often have more impact on quality of life than cognitive improvements alone.
Safety and efficacy of donepezil hydrochloride in patients with mild to moderate Alzheimer's disease: Findings of an observational study. [2021]Alzheimer's disease (AD), a progressive brain disorder, is the most common cause of dementia among the elderly. Donepezil hydrochloride is a potent, reversible, and highly selective inhibitor of acetylcholinesterase (AChE). It is chemically distinct from other cholinesterase (ChE) inhibitors which are effective in the treatment of AD.
[Adverse events causing discontinuation of donepezil for Alzheimer's dementia]. [2018]The objective was to investigate the frequency of adverse events (AE) as a cause for discontinuation of donepezil treatment for Alzheimer's dementia (DAT) in a geriatric memory unit.
The pharmacology of donepezil: a new treatment of Alzheimer's disease. [2019]Donepezil (donepezil hydrochloride, E-2020, Aricept, Eisai), launched in March 1997, was the first drug to be marketed for the symptomatic treatment of Alzheimer's disease (AD) in the UK. It had been launched a year earlier in the US where clinicians had already had experience of tacrine (THA). Donepezil is a piperidine based, potent, specific, non-competitive and reversible inhibitor of acetylcholinesterase (AChE). It is structurally dissimilar from other established cholinesterase inhibitors, namely THA (an acridine compound) and the carbamates, physostigmine and rivastigmine and has a pharmacokinetic and tolerability profile distinct from these agents. Experimentally, donepezil inhibits AChE activity in human erythrocytes and increases extracellular acetylcholine levels in the cerebral cortex and the hippocampus of the rat. Pharmacologically, donepezil has a half-life of approximately 70 h lending itself to once daily administration. The most common adverse events reported in clinical trials have been gastrointestinal, typically nausea, vomiting, diarrhoea and constipation. Headache, dizziness and sleep disturbance have also been reported; there has been no evidence of hepatotoxicity. Clinically a number of placebo-controlled trials have shown that donepezil 5 or 10 mg daily was associated with significant improvements in cognitive function, as assessed by the Alzheimer's disease Assessment Scale-cognitive subscale (ADAS cog) after 12 or 24 weeks treatment. Significant improvements in global function and activities of daily living have also been demonstrated after 24 weeks treatment compared with placebo in patients with mild to moderate AD. Donepezil was the first rational treatment available in the UK for this disabling condition and as such received considerable attention. Much of the original attention was negative, ostensibly based on the scientific view that there was not enough published evidence to justify widespread use, but this was driven by concerns about the potentially high drug costs if all patients with AD were eligible to receive it. Considerable data have now been produced from Phase II, III and post-marketing surveillance. This drug evaluation will review the basic pharmacology of donepezil and place it in context with the trial data and the author's clinical experience with the drug.