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Cholinesterase Inhibitor
Donepezil for Dementia (δND Trial)
Phase 2 & 3
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
δND Trial 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.Check my eligibility
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.See study design
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.
δND Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
dTEL change
Secondary outcome measures
ADIPOKINES change
Other outcome measures
Dementia "Reversion"
δND Trial Design
2Treatment groups
Active Control
Group I: Predicted RespondersActive Control1 Intervention
Group assignment determined by a response predictor algorithm derived from remotely acquired caregiver reports of cognitive performance.
Group II: Predicted Non-RespondersActive Control1 Intervention
Group assignment determined by a response predictor algorithm derived from remotely acquired caregiver reports of cognitive performance.
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
452 Previous Clinical Trials
91,214 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,671 Previous Clinical Trials
28,016,863 Total Patients Enrolled
Donald R. Royall, MDPrincipal InvestigatorUniversity of Texas
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
If I meet the qualifications, can I sign up for this research project?
"This study is looking for 200 patients that suffer from dementia and are aged between 65 and 100 years old. The most important qualifiers for participants are as follows: being able to walk and communicate, a GDS score of 6 or lower, a dECog score of -1.0 or higher."
Answered by AI
If a potential patient is below the age of 40, can they still be a part of this research?
"The aim of this clinical trial is to recruit elderly patients who are below 100 years of age."
Answered by AI
We are interested in enrolling in this clinical trial, are there any available positions?
"Unfortunately, this study is no longer looking for new participants. The last date that this study was recruiting was October 19th, 2022, according to the information available on clinicaltrials.gov. However, there are 1174 other trials that are still looking for patients."
Answered by AI
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