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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00314912
Recruitment Status : Unknown
Verified July 2007 by Bellus Health Inc.
Recruitment status was:  Active, not recruiting
First Posted : April 17, 2006
Last Update Posted : July 16, 2007
Information provided by:
Bellus Health Inc

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Tramiprosate (3APS) Phase 3

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 650 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Extension of the Phase III Study CL-758007 With Tramiprosate (3APS) in Patients With Alzheimer's Disease
Study Start Date : May 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. To evaluate the long-term safety of Tramiprosate (3APS).

Secondary Outcome Measures :
  1. To provide additional long-term data on the efficacy of Tramiprosate (3APS).

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00314912

United States, California
San Francisco Clinical Research Center
San Francisco, California, United States
Sponsors and Collaborators
Bellus Health Inc Identifier: NCT00314912     History of Changes
Other Study ID Numbers: CL-758017
First Posted: April 17, 2006    Key Record Dates
Last Update Posted: July 16, 2007
Last Verified: July 2007

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs