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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00380302
Recruitment Status : Completed
First Posted : September 25, 2006
Last Update Posted : December 19, 2008
Sponsor:
Information provided by:
Sanofi

Study Description
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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.


Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: AVE1625 Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : September 2006
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability throughout the study:adverse events collected by spontaneous report
  2. physical examination and neurological assessment
  3. vital sign monitoring, clinical laboratories, and ECGs.
  4. Efficacy variables:measures of change in cognition, global functioning and behavior at week 12.

Secondary Outcome Measures :
  1. Pharmacokinetic parameters will be assessed throughout the 12-week treatment period.

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00380302


Locations
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United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
France
Sanofi-Aventis Administrative Office
Paris, France
Italy
Sanofi-Aventis Administrative Office
Milano, Italy
Netherlands
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Sweden
Sanofi-Aventis Administrative Office
Bromma, Sweden
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: ICD CSD Sanofi
More Information
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Additional Information:

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Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00380302    
Other Study ID Numbers: ACT10019
EUDRACT: 2006-002317-12
First Posted: September 25, 2006    Key Record Dates
Last Update Posted: December 19, 2008
Last Verified: December 2008
Keywords provided by Sanofi:
Alzheimer's disease
symptomatic
cognition
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders