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

NCT ID: NCT00380302

Last Updated: 2008-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer Disease

Keywords

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Alzheimer's disease symptomatic cognition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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AVE1625

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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ICD CSD

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Site Status

Sanofi-Aventis Administrative Office

Paris, , France

Site Status

Sanofi-Aventis Administrative Office

Milan, , Italy

Site Status

Sanofi-Aventis Administrative Office

Gouda, , Netherlands

Site Status

Sanofi-Aventis Administrative Office

Bromma, , Sweden

Site Status

Countries

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United States France Italy Netherlands Sweden

Related Links

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Other Identifiers

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EUDRACT: 2006-002317-12

Identifier Type: -

Identifier Source: secondary_id

ACT10019

Identifier Type: -

Identifier Source: org_study_id