δ in Dementia Clinical Trials

• Status: Not yet recruiting
• Trial end date: 2027-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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 with cognitive impairment will be treated for six-months with donepezil. 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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborator: National Institute on Aging (NIA)
• Treatments: Donepezil

Criteria

Inclusion Criteria:

• Ambulatory outpatient volunteers with competent informants

• Aged 65-100 years

• Clinical diagnosis of AD, or MCI

• Capacity to give informed consent

• Geriatric Depression Scale (GDS) (15 item) score ≤ 6

• No significant visual or hearing impairments

• A standardized dECog score between 0.0 and -1.0 relative to ADNI's cohort

Exclusion Criteria:

• A self-reported diagnosis of "Major Depression" (treatment with "antidepressants" not exclusionary)

• A history of psychosis, including visual hallucinations

• History or treatment for Parkinson's, or tremor, or Rapid Eye Movement (REM) behavior disorder

• History or treatment for atrial fibrillation

• Treatment for cancer in the last 5 years (excluding skin cancers)

• Major surgery in the last year

• Current treatment with acetylcholinesterase inhibitor (AChEI) (memantine is acceptable). -Potential subjects on an AChEI can washout for three months and be rescreened.

• Current treatment with anti-convulsants, mood stabilizers, neuroleptics, opiates, muscle relaxants, or systemic steroids