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NCT05592678: δND

δ in Dementia Clinical Trials

Recruiting now NA Last updated 14 April 2026
What this trial tests

NA trial testing Donepezil in Alzheimer's Disease (AD) in 200 participants. Currently enrolling.

Timeline
5 August 2024
Primary endpoint
30 November 2028
30 November 2028

Quick facts

Lead sponsorThe University of Texas Health Science Center at San Antonio
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment200
Start date5 August 2024
Primary completion30 November 2028
Estimated completion30 November 2028
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

The University of Texas Health Science Center at San Antonio

Who can join

Adults 65 to 100, any sex, with Alzheimer's Disease (AD) or Dementia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Alzheimer's disease drug development pipeline: 2023.
    Cummings J, Zhou Y, Lee G, Zhong K, et al · · 2023 · cited 326× · PMID 37251912 · DOI 10.1002/trc2.12385
  2. Alzheimer's disease drug development pipeline: 2024.
    Cummings J, Zhou Y, Lee G, Zhong K, et al · · 2024 · cited 209× · PMID 38659717 · DOI 10.1002/trc2.12465
  3. Fountain of youth-Targeting autophagy in aging.
    Danics L, Abbas AA, Kis B, Pircs K. · · 2023 · cited 2× · PMID 37065462 · DOI 10.3389/fnagi.2023.1125739

Verify or expand the search:

Other trials of Donepezil

Trials testing the same drug.

Other recruiting trials for Alzheimer's Disease (AD)

Currently open trials in the same condition.

Other The University of Texas Health Science Center at San Antonio trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05592678.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing