A simple genetic stratification method for lower cost, more expedient clinical trials in early Alzheimer's disease: A preliminary study of tau PET and cognitive outcomes.
Alzheimers Dement
; 19(7): 3078-3086, 2023 07.
Article
in En
| MEDLINE
| ID: mdl-36701211
ABSTRACT
INTRODUCTION:
Identifying individuals who are most likely to accumulate tau and exhibit cognitive decline is critical for Alzheimer's disease (AD) clinical trials.METHODS:
Participants (N = 235) who were cognitively normal or with mild cognitive impairment from the Alzheimer's Disease Neuroimaging Initiative were stratified by a cutoff on the polygenic hazard score (PHS) at 65th percentile (above as high-risk group and below as low-risk group). We evaluated the associations between the PHS risk groups and tau positron emission tomography and cognitive decline, respectively. Power analyses estimated the sample size needed for clinical trials to detect differences in tau accumulation or cognitive change.RESULTS:
The high-risk group showed faster tau accumulation and cognitive decline. Clinical trials using the high-risk group would require a fraction of the sample size as trials without this inclusion criterion.DISCUSSION:
Incorporating a PHS inclusion criterion represents a low-cost and accessible way to identify potential participants for AD clinical trials.Key words
Full text:
1
Database:
MEDLINE
Main subject:
Alzheimer Disease
/
Cognitive Dysfunction
Type of study:
Health_economic_evaluation
/
Prognostic_studies
Limits:
Humans
Language:
En
Year:
2023
Type:
Article