Randomized Trial of Low-dose Naproxen in Cognitively Intact Persons at Risk of Alzheimer's Dementia
Status:
Completed
Trial end date:
2017-07-15
Target enrollment:
Participant gender:
Summary
Two-year double-masked trial of over-the-counter dosage of naproxen sodium vs placebo in 200
cognitively normal participants with a parental or multiplex first-degree family history
Alzheimer's disease (AD) dementia. Primary outcomes are decline in cognitive function and
slope of change in a summary Alzheimer Progression Score derived from serial assessment of
neuroimaging, biochemical, and sensori-neural biomarker indicators of pre-clinical disease --
all believed likely to reflect progress of preclinical AD in this high risk cohort.
Approximately 2/3 of participants have volunteered also for serial lumbar punctures for
analysis of cerebrospinal fluid. A two-year off-treatment delayed-washout phase is planned to
examine sustained treatment effects and evidence of disease modification.