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CompletedPhase 2

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

Investigations of Naproxen Treatment Effects in Pre-clinical Alzheimer's Disease (INTREPAD)

Asset

Naproxen

Listed sites

1

Recruiting sites

-

Enrollment

200

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criterion

•Age ≥55

Primary endpoint

•Trajectory of composite Alzheimer Progression Score (APS) from multiple

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDINTREPAD
NCT IDNCT02702817

Timeline

Milestones

Study start2012-08-01actual
Study first posted2016-03-09estimated
Primary completion2017-03-31actual
Study completion2017-07-15actual
Last update posted2017-08-01actual

Assets

Drug assets

Naproxen

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age55 Years
SexAll
Healthy volunteersAccepted

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

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Fluid / digital biomarkers
2
Other (unclassified)
2
Amyloid biomarkers
1
Safety / tolerability / PK
1

Amyloid biomarkers

1 endpoint
Secondary/protocol endpoint

CSF biomarkers of AD pathogenesis

Time frame:observed at baseline, after three months, and annually thereafter over two years following randomization (RZ), and two years thereafter off-treatment (delayed washout)

concentration, descriptive

Fluid / digital biomarkers

2 endpoints
Secondary/protocol endpoint

ratio of total and protein-bound naproxen concentrations as well as kinetics of drug accumulation and washout

Time frame:estimated at three months and annually thereafter for two years following RZ, with further two years delayed washout

concentration, descriptive

Secondary/protocol endpoint

biomarkers of inflammatory processes

Time frame:measured at three months and annually thereafter for two years following RZ, with further two years delayed washout

descriptive

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

frequency and severity of treatment-emergent adverse events

Time frame:collected in real-time over two years following RZ

event count, event

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

Trajectory of composite Alzheimer Progression Score (APS) from multiple cognitive and biomarker measures of pre-clinical Alzheimer's disease

Time frame:Two years for primary outcome, with intent to follow participants off-treatment for two-year observational delayed washout

descriptive

Secondary/protocol endpoint/low confidence

trajectory of cognitive abilities measured by global score on Repeatable Battery for Assessment of Neuropsychological Status

Time frame:observed at baseline, annually thereafter over two years following randomization (RZ), and two years further (delayed washout)

categorical status, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.