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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

162

participants targeted

Target at P75+ for phase_1 alzheimer-disease

Timeline

Completed

Started Sep 2006

Geographic Reach

5 countries

5 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

10 months study duration

Study Start

First participant enrolled

September 1, 2006

Completed

21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2006

Completed

3 days until next milestone

First Posted

Study publicly available on registry

September 25, 2006

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed

Last Updated

December 19, 2008

Status Verified

December 1, 2008

Enrollment Period

10 months

First QC Date

September 22, 2006

Last Update Submit

December 18, 2008

Conditions

Alzheimer Disease

Keywords

Alzheimer's diseasesymptomaticcognition

Outcome Measures

Primary Outcomes (4)

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 Outcomes (1)

Pharmacokinetic parameters will be assessed throughout the 12-week treatment period.

Interventions

AVE1625DRUG

Eligibility Criteria

Age50 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.