# Novel Methods for Clinical Trials in Dementia and Cognitive Decline

> **NIH NIH R01** · UNIVERSITY OF TEXAS HLTH SCIENCE CENTER · 2024 · $455,996

## Abstract

Abstract:
We will conduct an open-label double-blind group assignment clinical trial testing serum “adipokine” proteins
as the mediators of the Federal Drug Administration (FDA)-approved medication donepezil (Aricept®)’s effect
on the latent dementia severity metric “δ”. Adipokines are inflammatory proteins released by adipose tissues
and recently associated with cognitive decline. Our intent is to demonstrate multiple potential improvements in
the conduct of any future dementia-related clinical trial. For example, the use of telephone assessment
minimizes recruitment and assessment costs and protects participants from potential SARS-cov-2 exposure.
The entire protocol could be administered by telephone, if necessary, in subjects unvaccinated against
SARS-cov-2. In prior work, we have established the latent variable “δ” (for dementia) as a dementia-specific
cognitive phenotype. We will use δ to equate study groups on their baseline dementia severity and set the
recruitment threshold to maximize the potential for reversions back across δ’s dementia conversion threshold
if treatment is effective. We will deploy a novel “Line of identity (LOI)” algorithm to further select cases most
likely to benefit from our intervention (an example of precision medicine). We will use a second latent
dementia severity metric (dTEL) as a comprehensive dementia-specific outcome. Finally, we will test a latent
adipokine biomarker construct as a mediator of donepezil’s effect on δ. That will potentially establish a novel
mechanism for acetylcholinesterase inhibition.

## Key facts

- **NIH application ID:** 10837906
- **Project number:** 5R01AG080548-02
- **Recipient organization:** UNIVERSITY OF TEXAS HLTH SCIENCE CENTER
- **Principal Investigator:** DONALD R ROYALL
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $455,996
- **Award type:** 5
- **Project period:** 2023-05-15 → 2029-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10837906

## Citation

> US National Institutes of Health, RePORTER application 10837906, Novel Methods for Clinical Trials in Dementia and Cognitive Decline (5R01AG080548-02). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10837906. Licensed CC0.

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