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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2007 by Bellus Health Inc.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00314912
First Posted: April 17, 2006
Last Update Posted: July 16, 2007
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.
Information provided by:
Bellus Health Inc
  Purpose
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 Intervention Phase
Alzheimer's Disease Drug: Tramiprosate (3APS) Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bellus Health Inc:

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).

Estimated Enrollment: 650
Study Start Date: May 2006
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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00314912


Locations
United States, California
San Francisco Clinical Research Center
San Francisco, California, United States
Sponsors and Collaborators
Bellus Health Inc
  More Information

ClinicalTrials.gov Identifier: NCT00314912     History of Changes
Other Study ID Numbers: CL-758017
First Submitted: April 13, 2006
First Posted: April 17, 2006
Last Update Posted: July 16, 2007
Last Verified: July 2007

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