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
Recruitment status was Active, not recruiting
Sponsor:
Bellus Health Inc
Information provided by:
Bellus Health Inc
ClinicalTrials.gov Identifier:
NCT00088673
First received: July 30, 2004
Last updated: February 27, 2007
Last verified: February 2007
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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:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00088673
Show 67 Study Locations
Show 67 Study LocationsSponsors 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 Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Homotaurine |
GABA Agonists GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Anticonvulsants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013