NCT03900273

Development of Novel Measures for Alzheimer's Disease Prevention Trials

Development of Novel Measures of Cognition and Function for Alzheimer's Disease Prevention Trials

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: New York State Psychiatric Institute · Academic / Other
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This protocol focuses on novel measures of cognition and everyday function that have robust psychometrics and reduced practiced effects. They will be deployed in a parallel group study in which participants are randomized to assessment type (novel vs established) and receive serial assessments over a one year period in order to highlight contrasts between novel and established measures.

Detailed description

This protocol has the 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 400 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. Novel cognitive measures include tests of executive function, episodic memory, and processing speed combined into a single composite. Novel 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 ADAS-COG in order to determine which battery (novel or established) has better psychometric properties and is less sensitive to practice effects in this clinical trials structure.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
OTHER	No Practice Effects (NPE) cognitive battery, and Miami Computerized Functional Assessment Scale (CFAS)	Novel measures of Cognitive and Everyday function
OTHER	Preclinical Alzheimer's Cognitive Composite (PACC), Alzheimer's Disease Assessment Scale-Cognitive Scale (ADAS-Cog), and Functional Assessment Questionnaire (FAQ)	Established measures of Cognitive and Everyday Function

Timeline

• Start date: 2019-02-25
• Primary completion: 2025-08-31
• Completion: 2026-08-31
• First posted: 2019-04-03
• Last updated: 2025-10-31

Locations

4 sites across 1 country: United States