Alzheimer DiseasePhase 3NCT00088673
Evaluation of 3APS in Patients With Mild to Moderate Alzheimer's Disease
A Phase 3 study testing 3APS in people with Alzheimer Disease, run by Bellus Health Inc. - a GSK company at 67 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- 3APS
- How many people
- 950 participants
- Where
- 67 sitesin 2 countries
- Study dates
- Jun 2004to not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
67 sites in 2 countries.
67 sites in 2 countries
United States50 sites
Neurological Associates of Albany
Albany, New York
Comprehensive Neurology Specialists, PC
Atlanta, Georgia
Emory University
Atlanta, Georgia
The Memory Clinic
Bennington, Vermont
Brigham & Women's Hospital
Boston, Massachusetts
University Memory and Aging Center
Cleveland, Ohio
Research Center for Clinical Studies, Inc.
Darien, Connecticut, 06820
Radiant Research
Denver, Colorado
CNS Research, Inc.
East Providence, Rhode Island
Mood & Memory Clinic - Dr Aronson
Farmington Hills, Michigan
Neuropsychiatric Research Center of SouthWest Florida
Fort Myers, Florida
Margolin Brain Institute
Fresno, California
Berma Research Group
Hialeah, Florida
Central Arkansas Research
Hot Springs, Arkansas
University of Texas Mental Sciences Institute
Houston, Texas
Senior Clinical Trials, Inc.
Laguna Hills, California
Memory Enhancement Center
Long Branch, New Jersey
Clinical Research Services at Tennessee Christian Medical Center
Madison, Tennessee
Tukoi Institute for Clinical Research
Miami, Florida
Yale University, Alzheimer's Disesase Research Unit
New Haven, Connecticut
Eastside Comprehensive Medical Center
New York, New York
NYU School of Medicine
New York, New York
MUSC - Alzheimer's Research and Clinical Programs
North Charleston, South Carolina
Global Research and Consulting
Olean, New York
Nathan S. Kline Institute
Orangeburg, New York
Palm Beach Neurological Center
Palm Beach Gardens, Florida
Pivotal Research Centers
Peoria, Arizona
CNS Research Institute
Philadelphia, Pennsylvania
Farber Institute for Neurosciences
Philadelphia, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania
21st Century Neurology, a division of Xenoscience
Phoenix, Arizona
University of Pittsburgh ADRC
Pittsburgh, Pennsylvania
Quantum Laboratories Inc at the Memory Disorders Clinic, North Broward Medical Center
Pompano Beach, Florida
Memory and Aging Program, Butler Hospital
Providence, Rhode Island
Richard H. Weisler, MD, PA and Associates
Raleigh, North Carolina
University of Rochester-Program in Neurobehavioral Therapeutics
Rochester, New York
Air Force Villages-Freedom House Research (Study open to Air Force Village residents only)
San Antonio, Texas
Pacific Research Network, Inc.
San Diego, California
San Francisco Clinical Research Center
San Francisco, California
Southern Illinois University (SIU) School of Medicine, Department of Neurology
Springfield, Illinois
New England Research Institute
Stamford, Connecticut
Axiom Clinical Research
Tampa, Florida
Byrd Alzheimer's Center and Research Institute
Tampa, Florida
Stedman Clinical Trials
Tampa, Florida
University of South Florida, Suncoast Gerontology Center
Tampa, Florida
Neurology and Neuroscience Center of Ohio
Toledo, Ohio
Clinical Pharmaceuticals Trials, Inc.
Tulsa, Oklahoma
Georgetown University Medical Center
Washington D.C., District of Columbia
Premiere Research Institute Palm Beach Neurology
West Palm Beach, Florida
Wake Forest University School of Medicine, Department of Psychiatry and Behavioral Medicine
Winston-Salem, North Carolina
Canada17 sites
Study site
Calgary, Alberta
Clinique Neuro Rive-Sud
Greenfield Park, Quebec
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia
Queen's University
Kingston, Ontario
Geriatric Clinical Trials Group, Parkwood Hospital
London, Ontario
Hôpital Maisonneuve-Rosemont, Recherche Clinique de Neurologie
Montreal, Quebec
Jewish General Hospital- Memory Clinic
Montreal, Quebec
Study site
Ottawa, Ontario
The Medical Arts Health Research Group, a Division of PCT Networks, Inc.
Penticton, British Columbia
Hôpital de l'Enfant-Jésus
Québec, Quebec
Memory & Motor Skills Disorders Clinic
Québec, Quebec
St. Joseph's Hospital
Saint John, New Brunswick
Centre de recherche Novabyss
Sherbrooke, Quebec
Gerontion Research
Toronto, Ontario
Sunnybrook and Women's College Health Science Centre
Toronto, Ontario
Toronto Memory Program
Toronto, Ontario
McGill Centre for Studies in Aging
Verdun (Montreal), Quebec
About this study
Official title: 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.
- Conditions
- Alzheimer Disease
- Being tested
- 3APS
- Keywords
- Alzheimer Disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3APSDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2004 (estimated)
- Study startJun 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 950 participants
Sponsor and investigators
- Lead sponsor
- Bellus Health Inc. - a GSK company
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00088673
- Sponsor's protocol ID
- CL-758007
- Status last verified
- Feb 2007
- First submitted
- 30 Jul 2004
- Last updated
- 28 Feb 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study of the Efficacy and Safety of 3APS in Patients With Mild to Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00088673
- Acronym / sponsor ID
- CL-758007
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 950 participants
- Lead sponsor
- Bellus Health Inc. - a GSK companyIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- First posted
- 3 Aug 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3APS | Drug | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
67 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 3APS in people with Alzheimer Disease, run by Bellus Health Inc. - a GSK company at 67 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2007.