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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 because the information has not been verified recently.
Verified July 2007 by Bellus Health Inc.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Bellus Health Inc
ClinicalTrials.gov Identifier:
NCT00314912
First received: April 13, 2006
Last updated: July 13, 2007
Last verified: July 2007
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314912

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

No publications provided

ClinicalTrials.gov Identifier: NCT00314912     History of Changes
Other Study ID Numbers: CL-758017
Study First Received: April 13, 2006
Last Updated: July 13, 2007
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Homotaurine
 GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013