No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
65 – 100
Sex
Any
Study type
Interventional
Purpose
Other
Participants needed
200 (estimated)
Sponsor
The University of Texas Health Science Center at San Antonio · Other
Who this trial is looking for
This trial is looking for older adults with cognitive decline or Alzheimer's disease. Participants will receive donepezil, a medication used for Alzheimer's, and their caregivers will play a role in the study.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 65 and 100 years old
I have been diagnosed with Alzheimer's disease or mild cognitive impairment
I can give informed consent
I have a GDS score of 8 or less
I do not have significant visual or hearing impairments
I have a standardized dECog score between 1.0 and 5.0
I have a co-informant to help provide information
You may not be able to join if
I have a history of psychosis
I have a history or treatment for Parkinson's disease
I have a history of bradycardia or fainting
I have had treatment for cancer in the last 5 years
I have had major surgery in the last year
I have had treatment for seizures with anticonvulsants
I have received treatment for agitation or psychosis with neuroleptics
I am currently taking donepezil or any other AChEI
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Ambulatory outpatient volunteers with co-informants.
2. Aged 65-100 years
3. Clinical diagnosis of AD, or MCI.
4. Capacity to give informed consent.
5. GDS score (15 item) ≤ 8.
6. No significant visual or hearing impairments
7. Standardized dECog score between 1.0 and 5.0 rel…
Inclusion Criteria:
1. Ambulatory outpatient volunteers with co-informants.
2. Aged 65-100 years
3. Clinical diagnosis of AD, or MCI.
4. Capacity to give informed consent.
5. GDS score (15 item) ≤ 8.
6. No significant visual or hearing impairments
7. Standardized dECog score between 1.0 and 5.0 relative to ADNI's cohort.
Exclusion Criteria:
1. A history of psychosis, including visual hallucinations;
2. History or treatment for Parkinson's, or tremor, or Rapid Eye Movement (REM) behavior disorder;
3. History of bradycardia or syncopal events;
4. Treatment for cancer in the last 5 years (excluding skin cancers);
5. Major surgery in the last year;
6. Treatment for a seizure disorder with anticonvulsants;
7. Treatment for agitation or psychosis with neuroleptics (treatment of anxiety or insomnia allowed);
8. Current treatment with donepezil or any other AChEI or exposure within the last six months
9. With a recently started Donepezil Rx (\< 2 weeks), inability to stop Donepezil treatment for 14 days prior to study enrollment.
10. AChEI treatment not appropriate due to negative risk/benefit ratio based on medical Hx and symptoms during screening. Evaluated by PI and referring clinician.
11. Co-participation in another study that the PI feels would pose a safety risk or adversely affect data integrity of this study.
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