Back to resultsActivity of AVE1625 in Mild to Moderate Alzheimer's Patients.
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
AVE1625
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer's disease, symptomatic, cognition
Eligibility 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
Sites / Locations
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
Outcomes
Primary Outcome Measures
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 Outcome Measures
Pharmacokinetic parameters will be assessed throughout the 12-week treatment period.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00380302
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Alzheimer's disease, symptomatic, cognition
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
AVE1625
Primary Outcome Measure Information:
Title
Safety and tolerability throughout the study:adverse events collected by spontaneous report
Title
physical examination and neurological assessment
Title
vital sign monitoring, clinical laboratories, and ECGs.
Title
Efficacy variables:measures of change in cognition, global functioning and behavior at week 12.
Secondary Outcome Measure Information:
Title
Pharmacokinetic parameters will be assessed throughout the 12-week treatment period.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Sanofi-Aventis Administrative Office
City
Paris
Country
France
Facility Name
Sanofi-Aventis Administrative Office
City
Milano
Country
Italy
Facility Name
Sanofi-Aventis Administrative Office
City
Gouda
Country
Netherlands
Facility Name
Sanofi-Aventis Administrative Office
City
Bromma
Country
Sweden
12. IPD Sharing Statement
Links:
URL
http://www.sanofi-aventis.com
Description
Related Info
Learn more about this trial
Activity of AVE1625 in Mild to Moderate Alzheimer's Patients.
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