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

Sanofi

Status and phase: Completed; Phase 2; Phase 1

Conditions: Alzheimer Disease

Treatments: Drug: AVE1625

Study type: Interventional

Funder types: Industry

Identifiers

NCT00380302

ACT10019

EUDRACT: 2006-002317-12

Details and patient eligibility

About

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.

Enrollment: 162 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind