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
Information provided by:
Bellus Health Inc
First received: April 13, 2006
Last updated: July 13, 2007
Last verified: July 2007
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.
Drug: Tramiprosate (3APS)
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||An Open-Label Extension of the Phase III Study CL-758007 With Tramiprosate (3APS) in Patients With Alzheimer's Disease
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:
| Study Start Date:
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
|Ages Eligible for Study:
||50 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
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.
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314912
|San Francisco Clinical Research Center
|San Francisco, California, United States |
Bellus Health Inc
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 13, 2006
||July 13, 2007
||United States: Food and Drug Administration
Canada: Health Canada
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 23, 2014
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Nervous System Diseases
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs