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: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Douglas Mental Health University Institute
• Collaborators: Johns Hopkins University; McGill University
• Treatments: Naproxen

Criteria

Inclusion Criteria:

• good physical health including normal hemoglobin and hematocrit

• history or documentation of AD dementia in at least one parent, or in two siblings

• cognitive performance without diagnosable deficit such as dementia, "mild cognitive impairment"

• must have spouse or companion able to accompany participant for clinic visits

• six or more years of formal education

• fluent in either English or French

• provision of informed consent

Exclusion Criteria:

• no current peptic ulcer disease

• no history of prior peptic ulcer with bleed, perforation, intestinal obstruction

• no major psychiatric disturbance

• no regular use (4 or more doses per week) of aspirin, other non-steroidal anti-inflammatory drug (NSAID), opiate or other pain medication

• no use, present or past, of acetylcholinesterase inhibitors or memantine

• no regular use of vitamin E at dosage of 600 i.u.

• no drug or alcohol dependence

• no allergy to NSAIDs or sulfa antibiotics