CompletedPhase 1 / PHASE2

Activity of AVE1625 in Mild to Moderate Alzheimer's Patients.

A Double-Blind Placebo-Controlled Study of the Activity of AVE1625 at Doses of 10 mg and 40mg for 12 Weeks in Patients With Mild to Moderate Alzheimer's Disease

Lead sponsor

Sanofi

Asset

AVE1625

Listed sites

Recruiting sites

Enrollment

162

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoints

•Safety and tolerability throughout the study:adverse events collected•Physical examination and neurological assessment•Vital sign monitoring, clinical laboratories, and ECGs

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 IDACT10019

SecondaryEUDRACT: 2006-002317-12

NCT IDNCT00380302

Timeline

Milestones

Study start2006-09 (month precision)

Study first posted2006-09-25estimated

Primary completion2007-07actual (month precision)

Study completion2007-07actual (month precision)

Last update posted2008-12-19estimated

Assets

Drug assets

AVE1625

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•The diagnosis of Alzheimer's disease

•Recent brain image(Computerized Axial Tomographic Scan -CAT scan or Magnetic Resonance Imaging - MRI)

•Mild to moderate range of disease; not too severe

Exclusion criteria

•Severe or unstable medical diseases

•Neurological disorder other than Alzheimer's disease

•Depression that is not well controlled

•Treatment with memantine

•Inpatient in a total care facility (e.g.: Nursing home)

•Lack of reliable caregiver

Endpoints (5)

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

Safety / tolerability / PK

Behavior / neuropsychiatric

Other (unclassified)

Behavior / neuropsychiatric

1 endpoint

Primary/protocol endpoint

Efficacy variables:measures of change in cognition, global functioning and behavior at week 12.

change from baseline, improvement

Safety / tolerability / PK

3 endpoints

Primary/protocol endpoint

Safety and tolerability throughout the study:adverse events collected by spontaneous report

event count, event

Primary/protocol endpoint

vital sign monitoring, clinical laboratories, and ECGs.

descriptive

Secondary/protocol endpoint

Pharmacokinetic parameters will be assessed throughout the 12-week treatment period.

descriptive

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

physical examination and neurological assessment

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.