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

Alzheimer Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00380302
• Other study ID #: ACT10019
• Secondary ID: EUDRACT: 2006-00
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 22, 2006
• Last updated: December 18, 2008
• Start date: September 2006
• Est. completion date: July 2007

Study information

• Verified date: December 2008
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationItaly: Ethics CommitteeFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• AVE1625

Locations

Country	Name	City	State
France	Sanofi-Aventis Administrative Office	Paris
Italy	Sanofi-Aventis Administrative Office	Milano
Netherlands	Sanofi-Aventis Administrative Office	Gouda
Sweden	Sanofi-Aventis Administrative Office	Bromma
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  France,  Italy,  Netherlands,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability throughout the study:adverse events collected by spontaneous report
Primary	physical examination and neurological assessment
Primary	vital sign monitoring, clinical laboratories, and ECGs.
Primary	Efficacy variables:measures of change in cognition, global functioning and behavior at week 12.
Secondary	Pharmacokinetic parameters will be assessed throughout the 12-week treatment period.

External Links

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