Brief Summary

The primary objective is to assess the long term safety/tolerability of 4 mg/day of SR57667B in comparison to placebo in patients with mild-to-moderate Alzheimer's Disease (AD). A secondary objective is to describe the long term progression of Alzheimer's symptoms in patients treated by 4 mg/day of SR57667B.

Trial Health

On Track

Trial Health Score

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

Enrollment

390

participants targeted

Target at P75+ for phase_2 alzheimer-disease

Timeline

Completed

Started Mar 2004

Geographic Reach

7 countries

7 active sites

Status

completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.7 years study duration

Study Start

First participant enrolled

March 1, 2004

Completed

1.9 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2006

Completed

1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2006

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed

Last Updated

December 23, 2008

Status Verified

December 1, 2008

Enrollment Period

2.7 years

First QC Date

January 31, 2006

Last Update Submit

December 22, 2008

Conditions

Alzheimer Disease

Keywords

Alzheimer diseasenerve growth factorsClinical Trial

Outcome Measures

Primary Outcomes (1)

Adverse events recorded quarterly.

Secondary Outcomes (1)

ADAS-cog, CDR, MMSE, CGIC, ADCS-ADL, NPI measured at baseline and at 2,6,9 and 12 months.

Interventions

SR57667BDRUG

Eligibility Criteria

Age50 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Patients who have participated in Study EFC5286 and completed the study.
Patient, identified caregiver and, if applicable, patient surrogate (primary relative, legal guardian, medical proxy) have given their informed written consent and are capable of following study procedures specifically for this LTS5283 extension.

You may not qualify if:

Females who are pregnant or breast-feeding.
Females of child bearing potential (premenopausal female biologically capable of becoming pregnant) must have a confirmed negative serum b-HCG pregnancy test at the screening visit,and must use an acceptable method of birth control.

Contact the study team to confirm eligibility.