# Novel Cognitive and Functional Measures for Alzheimer's Disease Prevention Trials: Sensitivity to Biomarkers

> **NIH NIH R01** · NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC · 2020 · $637,919

## Abstract

Project Summary/Abstract
 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. Our funded parent grant (1R01AG051346)
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 are conducting 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 vs. established instruments) 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 System (CFAS) against established measures that include the PACC, ADAS-Cog, and FAQ. Our
Revision (Competing Supplement) will further test the sensitivity of the novel measures to: 1. hippocampal
atrophy and cortical thinning over a one-year interval by adding an additional MR scan at the one-year
endpoint of the study; and 2. Collection of additional Blood-based (BB) biomarkers at baseline and endpoint
that include total-tau, and Nfl. These are related to AD pathology and in the case of Neurofilament light chain
(Nfl), to neuroaxonal injury. As such these new measures should provide convergent data as to the utility of the
new measures. Additionally, we will also compare the sensitivity of the novel measures to the established
measures with respect to the additional data collected in this expansion of the study. We are requesting
funding for the final three years of our parent R01. Thus, in AIM 1. We will assess the relationship between
change from baseline to endpoint in MR measures and change in novel and established cognitive and
functional measures. We predict that the change score in novel measures will be more highly associated with
change in MR measures than established measures. AIM 2. A. We will assess the relationship between
changes in BB biomarkers total tau and Nfl, measured at baseline and endpoint and changes in novel and
established cognitive and functional measures. B. We will assess the ability of the biomarkers to predict
cognitive decline. We predict that for A. and B. associations will be more robust in the novel measures group...

## Key facts

- **NIH application ID:** 10051816
- **Project number:** 3R01AG051346-03S1
- **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:** 2020
- **Award amount:** $637,919
- **Award type:** 3
- **Project period:** 2018-09-01 → 2023-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10051816

## Citation

> US National Institutes of Health, RePORTER application 10051816, Novel Cognitive and Functional Measures for Alzheimer's Disease Prevention Trials: Sensitivity to Biomarkers (3R01AG051346-03S1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10051816. Licensed CC0.

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