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Cognitive decline across five cognitive batteries: Sample size implications for clinical trials.
Andrea R Zammit1,2, Ana W Capuano1,3, Lisa L Barnes1,2,3
1Rush Alzheimer's Disease Center Rush University Medical Center Chicago Illinois USA.
Alzheimer'S & Dementia (New York, N. Y.)
|July 17, 2025
Summary
The Preclinical Alzheimer's Composite with Semantic Processing (PACC5) shows greater statistical power for anti-amyloid trials in early Alzheimer's disease. This composite requires a smaller sample size, improving the efficiency of clinical trial design for detecting cognitive decline.
Area of Science:
- Neuroscience
- Clinical Trials
- Biostatistics
Background:
- Alzheimer's Disease (AD) research focuses on anti-amyloid treatments for preclinical stages.
- Statistical power is crucial for designing effective clinical trials to detect treatment effects.
- Cognitive composite measures are used to assess decline in early AD.
Purpose of the Study:
- To evaluate the statistical power of five cognitive composite endpoints for a theoretical 5-year randomized trial of anti-amyloid treatment in preclinical Alzheimer's Disease.
- To determine which cognitive composite offers the best statistical power for detecting a 30% reduction in cognitive decline.
- To inform the design of future clinical trials by identifying optimal outcome measures.
Main Methods:
- Utilized annual cognitive assessments from 517 individuals with post-mortem confirmed Alzheimer's Disease (AD) pathology to represent amyloid positivity.
- Calculated required sample sizes for a 30% reduction in 5-year cognitive decline slopes across five cognitive composites.
- Compared statistical power across the Alzheimer's Prevention Initiative Preclinical Composite Cognitive Test (APCC), Preclinical Alzheimer's Composite with Semantic Processing (PACC5), Preclinical Alzheimer's Cognitive Composite (PACC), and global/episodic memory composites.
Main Results:
- The Preclinical Alzheimer's Composite with Semantic Processing (PACC5) demonstrated the highest statistical power, requiring the smallest sample size (n=1424).
- Sample size estimates for PACC5 were lower than for APCC (n=1633), PACC (n=1822), and an episodic memory composite (n=3141).
- Sample size estimates for PACC5 were similar to a global composite (n=1267).
Conclusions:
- The PACC5 composite offers superior statistical power for detecting cognitive decline in preclinical Alzheimer's Disease trials.
- Incorporating measures like semantic fluency into cognitive composites can enhance statistical power.
- Optimizing cognitive composite selection is vital for improving the efficiency and success of anti-amyloid treatment trials.
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