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

Tracking Information
First Received Date ^ICMJE	April 13, 2006
Last Updated Date	July 13, 2007
Start Date ^ICMJE	May 2006
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: April 13, 2006)	To evaluate the long-term safety of Tramiprosate (3APS).
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00314912 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 13, 2006)	To provide additional long-term data on the efficacy of Tramiprosate (3APS).
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Open-Label Extension of the Phase III Study With Tramiprosate (3APS) in Patients With Mild to Moderate Alzheimer's Disease
Official Title ^ICMJE	An Open-Label Extension of the Phase III Study CL-758007 With Tramiprosate (3APS) in Patients With Alzheimer's Disease
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
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Alzheimer's Disease
Intervention ^ICMJE	Drug: Tramiprosate (3APS)
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	650
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	50 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00314912
Other Study ID Numbers ^ICMJE	CL-758017
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Bellus Health Inc
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Bellus Health Inc
Verification Date	July 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top