Improving dementia treatment assessment methods

Novel Methods for Clinical Trials in Dementia and Cognitive Decline

This study is testing a new way to see if donepezil can help people with dementia feel better by looking at their thinking skills and daily activities, while also checking if certain markers in the body play a role in how well the treatment works.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 65 Years to 100 Years
• Sex: All
• Sponsor: The University of Texas Health Science Center at San Antonio (other)
• Locations: 1 site (San Antonio, Texas)
• Trial ID: NCT05592678 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to enhance the evaluation of interventions for dementia and cognitive decline by utilizing a latent variable, referred to as 'δ', which integrates cognitive performance with functional status. The study will involve pre-selecting participants based on their likelihood to benefit from the medication donepezil, which is approved for Alzheimer's Disease, and assessing its effects on dementia severity. Additionally, the trial will explore the role of adipokines as potential biomarkers that could mediate the treatment's effectiveness. Participants will be monitored through remote assessments conducted by caregivers to identify those most likely to respond to the intervention.

Who should consider this trial

Good fit: Ideal candidates include ambulatory individuals aged 65-100 with a clinical diagnosis of Alzheimer's Disease or Mild Cognitive Impairment who have competent informants.

Not a fit: Patients with significant visual or hearing impairments or those who do not meet the cognitive assessment criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and personalized treatment strategies for patients with dementia.

How similar studies have performed: Other studies have shown promise in using biomarkers and latent variables to improve treatment outcomes in dementia, suggesting this approach may be viable.

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 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.

Where this trial is running

San Antonio, Texas

• Univeristy of Texas Health Science Center at San Antonio (UTHSCSA) — San Antonio, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Donald R. Royall, MD — University of Texas
• Study coordinator: Samuel Guess

Conditions: Alzheimer's Disease, Dementia, Cognitive Decline, Mild Cognitivie Impairment, adipokines, cognition, dementia, functional status