---
title: "Activity of AVE1625 in Mild to Moderate Alzheimer's Patients."
nct_id: NCT00380302
overall_status: COMPLETED
phase: PHASE1, PHASE2
sponsor: Sanofi
study_type: INTERVENTIONAL
primary_condition: Alzheimer Disease
countries: United States, France, Italy, Netherlands, Sweden
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00380302.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00380302"
ct_last_update_post_date: 2008-12-19
last_seen_at: "2026-05-12T06:24:59.214Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Activity of AVE1625 in Mild to Moderate Alzheimer's Patients.

**Official Title:** 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

**NCT ID:** [NCT00380302](https://clinicaltrials.gov/study/NCT00380302)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1, PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 162
- **Lead Sponsor:** Sanofi
- **Conditions:** Alzheimer Disease
- **Start Date:** 2006-09
- **Completion Date:** 2007-07
- **CT.gov Last Update:** 2008-12-19

## Brief Summary

Primary: This study is being conducted to evaluate if AVE1625 is safe and tolerated in patients with Alzheimer's disease that is not too severe. There is also evaluation of whether patients who take the study medication improve compared to patients who take a placebo (sugar pill).

Secondary:The study will also evaluate the blood levels of the study medication, AVE1625 in patients who join the study.

## Eligibility

- **Minimum age:** 50 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Interventions

- **AVE1625** (DRUG)

## Primary Outcomes

- **Safety and tolerability throughout the study:adverse events collected by spontaneous report**
- **physical examination and neurological assessment**
- **vital sign monitoring, clinical laboratories, and ECGs.**
- **Efficacy variables:measures of change in cognition, global functioning and behavior at week 12.**

## Secondary Outcomes

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

## Locations (5)

- Sanofi-Aventis Administrative Office, Bridgewater, New Jersey, United States
- Sanofi-Aventis Administrative Office, Paris, France
- Sanofi-Aventis Administrative Office, Milan, Italy
- Sanofi-Aventis Administrative Office, Gouda, Netherlands
- Sanofi-Aventis Administrative Office, Bromma, Sweden

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.sanofi-aventis administrative office|bridgewater|new jersey|united states` — added _(2026-05-12)_
- `locations.sanofi-aventis administrative office|paris||france` — added _(2026-05-12)_
- `locations.sanofi-aventis administrative office|milan||italy` — added _(2026-05-12)_
- `locations.sanofi-aventis administrative office|gouda||netherlands` — added _(2026-05-12)_
- `locations.sanofi-aventis administrative office|bromma||sweden` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00380302.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00380302*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*