# Novel Cognitive and Functional Measure for Alzheimer's Disease Prevention Trials

> **NIH NIH R01** · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · 2022 · $2,109,311

## Abstract

PROJECT SUMMARY
 It has become increasingly appreciated that practice effects and ceiling effects could result in type 1 or
type 2 errors in clinical trials involving early stage AD populations, given the necessity of serial assessments.
This proposal has the overarching goal of validating novel cognitive and everyday functional measures that
have sharply attenuated practice effects and are not prone to ceiling effects for use in preclinical Alzheimer's
disease (AD) trials in which participants are cognitively within normal limits. To implement this, we will conduct
an innovative parallel group study in which 320 healthy, non-cognitively impaired older subjects are
randomized to one of two groups based on assessment type (novel instruments vs. established) and receive
three serial assessments over a one year period. We will employ this parallel group design in order to maintain
the structure of a clinical trial, while pari passu, highlighting contrasts between novel and established measures
and completely avoiding any interference effects between them. Our novel cognitive measures include tests of
executive function, episodic memory, and processing speed combined into a single composite. Our functional
measures involve computerized performance based, ecologically relevant instrumental activities. We will
compare our novel No Practice Effects (NPE) cognitive battery and Miami Computerized Functional
Assessment Scale (CFAS) against established measures that include the PACC, ADAS-Cog, and FAQ. In
preliminary data our novel measures demonstrated attenuated practice effects, high test-retest reliabilities,
equivalent alternate forms, and lack of ceiling effects. Moreover, we will also examine several biomarkers and
markers that may increase risk for AD (e.g., APOE e4 carrier status, hippocampal atrophy and AD cortical
thinning signature, family history of AD) in order to assess the sensitivity of the measures to these known
biomarkers and so provide evidence for or against the validity of the cognitive and functional tests.

## Key facts

- **NIH application ID:** 10440277
- **Project number:** 5R01AG051346-05
- **Recipient organization:** NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC
- **Principal Investigator:** Terry Goldberg
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $2,109,311
- **Award type:** 5
- **Project period:** 2018-09-01 → 2026-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10440277

## Citation

> US National Institutes of Health, RePORTER application 10440277, Novel Cognitive and Functional Measure for Alzheimer's Disease Prevention Trials (5R01AG051346-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10440277. Licensed CC0.

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