Evaluation of 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 February 2007 by Bellus Health Inc.
Recruitment status was Active, not recruiting

Sponsor:

Information provided by:

Bellus Health Inc

ClinicalTrials.gov Identifier:

NCT00088673

First received: July 30, 2004

Last updated: February 27, 2007

Last verified: February 2007

History of Changes

Tracking Information
First Received Date ^ICMJE	July 30, 2004
Last Updated Date	February 27, 2007
Start Date ^ICMJE	June 2004
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: February 8, 2006)	The two primary efficacy parameters are the change from baseline to month 18 in the Alzheimer's Disease Assessment Scale, cognitive subpart (ADAS-cog) and the clinical Deterioration Scale Sum of Boxes (CDR-SB) scores. The brain volume change from baseline as measured by Magnetic Resonance Imaging will also be assessed.
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00088673 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Evaluation of 3APS in Patients With Mild to Moderate Alzheimer’s Disease
Official Title ^ICMJE	A Phase III Study of the Efficacy and Safety of 3APS in Patients With Mild to Moderate Alzheimer’s Disease
Brief Summary	The purpose of this Phase III study is to evaluate the efficacy and safety of 3APS compared to placebo (inactive substance pill) in patients with mild to moderate Alzheimer’s disease.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Alzheimer Disease
Intervention ^ICMJE	Drug: 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	950
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients may be included in this study if they meet all of the following criteria: 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). Diagnosis of probable Alzheimer’s disease based on the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer’s Disease and Related Disorders Association (NINCDS-ADRDA criteria). Severity of dementia of mild to moderate degree as assessed by the Mini Mental State Examination (MMSE) performed at the screening visit. 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. Potential participant must be treated with conventional Alzheimer’s disease therapies and must be on stable dose for at least 4 months prior to the screening visit and during the entire study period. Fluency in English, French or Spanish (oral and written). Signed informed consent from potential participant or legal representative and caregiver. Exclusion Criteria: Patients will not be eligible to participate in the study if they meet any of the following criteria: Potential participant with any other cause of dementia. Life expectancy less than 2 years. Potential participant with a clinically significant and/or uncontrolled condition or other significant medical disease. Use of an investigational drug within 30 days prior to the screening visit or during the entire study. Previous use of 3APS. Patient recruitment is done by participating centers.
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, Canada

Administrative Information
NCT Number ^ICMJE	NCT00088673
Other Study ID Numbers ^ICMJE	CL-758007
Has Data Monitoring Committee	Yes
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	February 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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