Evaluation of 3APS in Patients With Mild to Moderate Alzheimer's Disease

Phase 3

• Conditions: Alzheimer Disease

• Registration Number: NCT00088673
• Lead Sponsor: Bellus Health Inc. - a GSK company

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 available

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2004-07-30
• Study First Submitted QC: 2004-08-02
• Study First Posted: 2004-08-03
• Status Verified: 2007-02
• Last Update Submitted: 2007-02-27
• Last Update Posted: 2007-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 950

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (65)

Pivotal Research Centers; 🇺🇸 Peoria, Arizona, United States

21st Century Neurology, a division of Xenoscience; 🇺🇸 Phoenix, Arizona, United States

Central Arkansas Research; 🇺🇸 Hot Springs, Arkansas, United States

Margolin Brain Institute; 🇺🇸 Fresno, California, United States

Senior Clinical Trials, Inc.; 🇺🇸 Laguna Hills, California, United States

Pacific Research Network, Inc.; 🇺🇸 San Diego, California, United States

San Francisco Clinical Research Center; 🇺🇸 San Francisco, California, United States

Radiant Research; 🇺🇸 Denver, Colorado, United States

Research Center for Clinical Studies, Inc.; 🇺🇸 Darien, Connecticut, United States

Yale University, Alzheimer's Disesase Research Unit; 🇺🇸 New Haven, Connecticut, United States

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