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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

July 30, 2004
February 27, 2007
June 2004
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  • 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.
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Complete list of historical versions of study NCT00088673 on ClinicalTrials.gov Archive Site
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Evaluation of 3APS in Patients With Mild to Moderate Alzheimer’s Disease
A Phase III Study of the Efficacy and Safety of 3APS in Patients With Mild to Moderate Alzheimer’s Disease

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Alzheimer Disease
Drug: 3APS
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
950
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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.

Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00088673
CL-758007
Yes
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Bellus Health Inc
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Bellus Health Inc
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP