δ in Dementia Clinical Trials — dND  

Dementia Clinical Trial

Official title: Novel Methods for Clinical Trials in Dementia and Cognitive Decline

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

Title: "Novel Methods for Clinical rials in Dementia and Cognitive Decline"

Study Description: This is a double-blind assignment open label clinical trial to test novel approaches to clinical trial methods. 1) The study team will pre-select cases most likely to benefit from adipokine modulation by a telephone assessment. 2) The study team will pre-select subjects with clinical and preclinical dementia most likely to respond to therapy. 3) The study team will test the drug donepezil's effect on dementia severity, in predicted responders and non-responders, as measured by a latent dementia phenotype "δ' and 4) test a latent Adipokines biomarker construct as a mediator of their association in the predicted responders.

Objectives:

Primary Objective: To test novel clinical trial methods relevant to dementia.

Secondary Objectives:

1. To test donepezil's effect on dementia severity as measured by δ.

2. To test Adipokines as a mediator of donepezil's effect on δ.

Endpoints: Primary Endpoint: Dementia severity as measured by the latent phenotype "δ" using the "dTEL" homolog.

Secondary Endpoint: Change in Adipokines as a mediator of donepezil's effect on dTEL. ;

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease (AD)
• Cognitive Decline
• Cognitive Dysfunction
• Dementia

• NCT number: NCT05592678
• Study type: Interventional
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Amy Saklad
• Phone: 210 567-8229
• Email: SAKLADA@uthscsa.edu
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: June 2024
• Completion date: November 2028