δ in Dementia Clinical Trials

NCT05592678 | Recruiting

• 2 other identifiers: HSC20220551HR01AG080548
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Alzheimer's Disease (AD); Dementia; Cognitive Decline; Mild Cognitivie Impairment (MCI)

Keywords

adipokines; cognition; dementia; functional status; intelligence

Outcome Measures

Primary Outcomes (1)

• dTEL change

  Change in a latent dementia-specific phenotype derived from cognitive assessment.

  At baseline, and weeks 4, 12 and 24.

Secondary Outcomes (1)

• ADIPOKINES change

  Baseline and week 24.

Other Outcomes (1)

• Dementia "Reversion"

  Week 24

Study Arms (2)

Predicted Responders

OTHER

Group assignment determined by a response predictor algorithm derived from remotely acquired caregiver reports of cognitive performance. The donepezil administered during the study is prescribed by the subject provider as standard of care.

Other: Donepezil

Predicted Non-Responders

OTHER

Group assignment determined by a response predictor algorithm derived from remotely acquired caregiver reports of cognitive performance. The donepezil administered during the study is prescribed by the subject provider as standard of care.

Other: Donepezil

Interventions

Donepezil OTHER

Donepezil is administered as a standard of care treatment by the subject's provider.

Also known as: Aricept ®

Predicted Non-Responders; Predicted Responders

Eligibility Criteria

• Age: 65 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify 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.
• No significant visual or hearing impairments
• Standardized dECog score between 1.0 and 5.0 relative to ADNI's cohort.

You may not qualify 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;
• 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.

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

Univeristy of Texas Health Science Center at San Antonio (UTHSCSA)

San Antonio, Texas, 78229-3900, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Cognitive Dysfunction

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Donald R. Royall, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samuel Guess

CONTACT

210 567 8133; guesss@uthscsa.edu

Floyd Jones

CONTACT

210 450 3158; JONESFA@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: a double-blind group assignment open label study, one group has suspected Adipokine-related dementia and the other group does not.

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 25, 2022
• Study Start: August 5, 2024
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data from this study may be requested from other researchers 5 years after the completion of the primary endpoint by contacting royall@uthscsa.edu

Locations

US (1)