BridgeMD
New treatment option for Alzheimer's Disease (AD)
Official title δ in Dementia Clinical Trials
ClinicalTrials.gov ID: NCT05592678
What this study is testing
- What it's testing
- 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?
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 to 100
You may be able to join if
- Ambulatory outpatient volunteers with co-informants.
- Aged 65-100 years
- Clinical diagnosis of AD, or MCI.
- Capacity to give informed consent.
- GDS score (15 item) ≤ 8.
You likely can't join if
- A history of psychosis, including visual hallucinations;
- History or treatment for Parkinson's, or tremor, or Rapid Eye Movement (REM) behavior disorder;
- History of bradycardia or syncopal events;
- Treatment for cancer in the last 5 years (excluding skin cancers);
- Major surgery in the last year;
- Treatment for a seizure disorder with anticonvulsants;
See the full eligibility criteria
- Ambulatory outpatient volunteers with co-informants.
- Aged 65-100 years
- Clinical diagnosis of AD, or MCI.
- Capacity to give informed consent.
- GDS score (15 item) ≤ 8.
- No significant visual or hearing impairments
- Standardized dECog score between 1.0 and 5.0 relative to ADNI's cohort.
- A history of psychosis, including visual hallucinations;
- History or treatment for Parkinson's, or tremor, or Rapid Eye Movement (REM) behavior disorder;
- History of bradycardia or syncopal events;
- Treatment for cancer in the last 5 years (excluding skin cancers);
- Major surgery in the last year;
- Treatment for a seizure disorder with anticonvulsants;
- Treatment for agitation or psychosis with neuroleptics (treatment of anxiety or insomnia allowed);
- Current treatment with donepezil or any other AChEI or exposure within the last six months
- With a recently started Donepezil Rx (\< 2 weeks), inability to stop Donepezil treatment for 14 days prior to study enrollment.
- AChEI treatment not appropriate due to negative risk/benefit ratio based on medical Hx and symptoms during screening. Evaluated by PI and referring clinician.
- Co-participation in another study that the PI feels would pose a safety risk or adversely affect data integrity of this study.
The study team makes the final eligibility decision.
Where it's taking place
- San Antonio, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.