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Cholinesterase Inhibitor
Donepezil for Dementia (δND Trial)
N/A
Waitlist Available
Led By Donald R. Royall, MD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, and weeks 4, 12 and 24.
Awards & highlights
No Placebo-Only Group
Summary
This trial will investigate if a medication can improve dementia severity in people with cognitive impairment and if biomarkers in the blood can predict how well they will respond.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Donepezil may cause side effects like nausea, diarrhea, insomnia, muscle cramps, fatigue and loss of appetite. Some people might experience more serious effects such as heart-related symptoms (slow heartbeat), seizures or trouble urinating.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at baseline, and weeks 4, 12 and 24.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, and weeks 4, 12 and 24.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
dTEL change
Secondary study objectives
ADIPOKINES change
Other study objectives
Dementia "Reversion"
Side effects data
From 2009 Phase 4 trial • 220 Patients • NCT001776711%
Suicide Attempt
1%
Myocardial infarcation with congestive heart failure
1%
stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
Donepezil
Placebo
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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.
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
475 Previous Clinical Trials
92,116 Total Patients Enrolled
5 Trials studying Dementia
2,001 Patients Enrolled for Dementia
National Institute on Aging (NIA)NIH
1,788 Previous Clinical Trials
28,184,572 Total Patients Enrolled
292 Trials studying Dementia
23,634,538 Patients Enrolled for Dementia
Donald R. Royall, MDPrincipal InvestigatorUniversity of Texas
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My cognitive function score is between 0.0 and -1.0, compared to a standard group.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.I have chronic diarrhea, a part of my colon removed, or irritable bowel syndrome.I have a history of slow heartbeat or fainting spells.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.I am currently taking medication for dementia.I am currently taking or have taken an AChEI medication in the past year.My doctor thinks AChEI treatment isn't right for me due to past health issues or symptoms.I am between 65 and 100 years old.I have not been treated for any cancer (except skin cancer) in the last 5 years.I am currently taking medication for seizures, mood, muscle relaxation, pain, or inflammation.I have been diagnosed with Major Depression.I have been diagnosed with Alzheimer's or show mild cognitive impairment.I do not have major problems with my sight or hearing.I have not had major surgery in the past year.
Research Study Groups:
This trial has the following groups:- Group 1: Predicted Responders
- Group 2: Predicted Non-Responders
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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