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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
  Purpose

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.


Condition Intervention Phase
Alzheimer Disease
Drug: 3APS
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase III Study of the Efficacy and Safety of 3APS in Patients With Mild to Moderate Alzheimer’s Disease

Resource links provided by NLM:


Further study details as provided by Bellus Health Inc:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 950
Study Start Date: June 2004
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
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: NCT00088673

  Show 67 Study Locations
Sponsors and Collaborators
Bellus Health Inc
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00088673     History of Changes
Other Study ID Numbers: CL-758007
Study First Received: July 30, 2004
Last Updated: February 27, 2007
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Bellus Health Inc:
Alzheimer Disease

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 23, 2014