# Enriching clinical trials requiring amyloid positivity with practice effects

> **NIH NIH R01** · UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH · 2021 · $723,233

## Abstract

The main objective of this new application is to demonstrate that individuals with
low practice effects on repeated cognitive testing across one week are likely to be identified as
“positive” on amyloid imaging and other biomarkers associated with Alzheimer's disease. This project
would also examine if short-term practice effects and amyloid deposition differ across the disease
spectrum in late adulthood by comparing older individuals who are cognitively intact to those with Mild
Cognitive Impairment and Alzheimer's disease. These findings would add to the supporting evidence of
practice effects as a marker of diagnosis, prognosis, and treatment response in normal aging, Mild
Cognitive Impairment, and dementing illnesses. By realizing the aims of this pragmatic project, we
would be able to offer more efficient screening of potential participants for clinical trials, which would
reduce participant burden and financial costs associated with these trials. Practice effects could also be
used to enrich trials with those more likely to progress and to monitor treatment benefit as a proximal
outcome measure. Practice effects also have considerable clinical benefits for diagnosis and prognosis
of cognitive disorders in late life. This project is consistent with the mission of the National Institute on
Aging.
Relevance. Many current clinical trials in Mild Cognitive Impairment and Alzheimer's disease are using
biomarkers (e.g., “positive” on amyloid imaging, atrophic hippocampi, APOE e4) as part of the inclusion
criteria. Similarly, biomarkers are becoming increasingly important in the diagnosis of Alzheimer's
disease and other types of dementia. However, many of these biomarkers are costly, invasive, provide
little clinical information, and may be only completed at sites with unique resources. There is a need for
more practical markers of disease and its progression, which could be used to enrich clinical trials.
Practice effects, collected on cognitive testing across one week, may fill this important gap. In the
current pragmatic project, we expect to provide clinicians and researchers with a new tool (i.e., practice
effects) for predicting current amyloid positivity in seniors with and without cognitive impairments. We
will also examine the relationship between short-term practice effects and other biomarkers associated
with Alzheimer's disease (e.g., atrophic hippocampi, APOE e4, functional connectivity of brain
networks). We expect to provide supporting evidence to include practice effects in future clinical trials in
normal aging, Mild Cognitive Impairment, and Alzheimer's disease.

## Key facts

- **NIH application ID:** 10158384
- **Project number:** 5R01AG055428-05
- **Recipient organization:** UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH
- **Principal Investigator:** KEVIN M DUFF
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $723,233
- **Award type:** 5
- **Project period:** 2017-09-15 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10158384

## Citation

> US National Institutes of Health, RePORTER application 10158384, Enriching clinical trials requiring amyloid positivity with practice effects (5R01AG055428-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10158384. Licensed CC0.

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