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Randomized Trial of Low-dose Naproxen in Cognitively Intact Persons at Risk of Alzheimer's Dementia

NCT02702817 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2017-08-01

No results posted yet for this study

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.

Conditions

  • Alzheimer Disease
  • Cognitive Decline Due to Alzheimer Disease
  • Mild Cognitive Impairment Due to Alzheimer Disease

Interventions

DRUG

Naproxen

pale blue oval tablets

DRUG

Placebo

pale blue oval tablets with no active ingredients, identical in appearance to naproxen intervention

Sponsors & Collaborators

Principal Investigators

  • John C S Breitner, MD, MPH · Dept of Psychiatry, McGill University Faculty of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-08-01
Primary Completion
2017-03-31
Completion
2017-07-15

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02702817 on ClinicalTrials.gov