Activity of AVE1625 in Mild to Moderate Alzheimer's Patie... | NCT00380302

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

NCT00380302

Sponsor

Sanofi

Status

Completed

Last Update Posted

Dec 19, 2008Estimated

Enrollment

162Actual

Phase

Phase 1Phase 2

Conditions

Alzheimer Disease

Interventions

AVE1625

Countries

United States
France
Italy
Netherlands
Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EUDRACT: 2006-002317-12

Status Module

Record Verification Date

Dec 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Jul 2007Actual

Completion Date

Jul 2007Actual

First Submitted Date

Sep 22, 2006

First Submission Date that Met QC Criteria

Sep 22, 2006

First Posted Date

Sep 25, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2008

Last Update Posted Date

Dec 19, 2008Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

162Actual

Name	Type	Description	Arm Group Labels	Other Names
AVE1625	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Pharmacokinetic parameters will be assessed throughout the 12-week treatment period.

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ICD CSD	Sanofi	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis Administrative Office		Bridgewater	New Jersey	08807	United States
Sanofi-Aventis Administrative Office

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C523652	AVE1625

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided