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

Primary Purpose

Alzheimer's Disease

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tramiprosate (3APS)
Sponsored by
Bellus Health Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • San Francisco Clinical Research Center

Outcomes

Primary Outcome Measures

To evaluate the long-term safety of Tramiprosate (3APS).

Secondary Outcome Measures

To provide additional long-term data on the efficacy of Tramiprosate (3APS).

Full Information

First Posted
April 13, 2006
Last Updated
July 13, 2007
Sponsor
Bellus Health Inc
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1. Study Identification

Unique Protocol Identification Number
NCT00314912
Brief Title
Open-Label Extension of the Phase III Study With Tramiprosate (3APS) in Patients With Mild to Moderate Alzheimer's Disease
Official Title
An Open-Label Extension of the Phase III Study CL-758007 With Tramiprosate (3APS) in Patients With Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Unknown status
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Bellus Health Inc

4. Oversight

5. Study Description

Brief 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.
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
650 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tramiprosate (3APS)
Primary Outcome Measure Information:
Title
To evaluate the long-term safety of Tramiprosate (3APS).
Secondary Outcome Measure Information:
Title
To provide additional long-term data on the efficacy of Tramiprosate (3APS).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
San Francisco Clinical Research Center
City
San Francisco
State/Province
California
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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