Open-Label Extension of the Phase III Study With Tramiprosate (3APS) in Patients With Mild to Moderate Alzheimer's Disease

Alzheimer's Disease Clinical Trial

Official title:

An Open-Label Extension of the Phase III Study CL-758007 With Tramiprosate (3APS) in Patients With Alzheimer's Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00314912
• Other study ID #: CL-758017
• Status: Active, not recruiting
• Phase: Phase 3
• First received: April 13, 2006
• Last updated: July 13, 2007
• Start date: May 2006

Study information

• Verified date: July 2007
• Source: Bellus Health Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The purpose of this Phase III open-label extension study is to evaluate the long-term safety of Tramiprosate (3APS) in patients with mild to moderate Alzheimer’s disease.

Description:

Duration of treatment: 12 months. Patients who complete the Phase III clinical trial will be offered the opportunity to receive Tramiprosate (3APS) in an open-label extension study

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 650
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• The patient must have successfully completed the full 78-week duration of the double-blind CL-758007 study.

• Male or female (age 50 years and older): Female must be of non-childbearing potential (i.e. surgically sterilized or at least 2 years post-menopausal).

• Patient must be living in the community with a reliable caregiver. Participant living in an assisted living facility may be included if study medication intake is supervised and participant has a reliable caregiver.

• The patient must be presenting a reasonably good nutritional status.

• Signed inform consent from the patient or legal representative.

Exclusion Criteria:

Patients will not be eligible to participate in the study if they meet any of the following criteria:

• The patient participates in another drug trial during the study.

• The patient with a clinically significant and/or uncontrolled condition or other significant medical disease.

• The patient is unable to swallow medication tablets.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Tramiprosate (3APS)

Locations

Country	Name	City	State
United States	San Francisco Clinical Research Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Bellus Health Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the long-term safety of Tramiprosate (3APS).
Secondary	To provide additional long-term data on the efficacy of Tramiprosate (3APS).