Alzheimer's DiseasePhase 2NCT00810147
A Phase II, Multicenter, Double Blind, Placebo-Controlled Safety, Tolerability Study of BMS-708163 in Patients With Mild to Moderate Alzheimer's Disease
A Phase 2 study testing BMS-708163 in people with Alzheimer's Disease, run by Bristol-Myers Squibb at 41 sites in 4 countries.
Trial summary
The purpose of this study is to determine the safety and tolerability of BMS-708163 in patients with mild to moderate Alzheimer's disease over a treatment period of 12-weeks and the course of any potential effects during a 12-week wash-out period Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- BMS-708163
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 209 participants
- Where
- 41 sitesin 4 countries
- Study dates
- Feb 2009to Jun 2010
- Phase
- Phase 2
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Mild to Moderate Alzheimer's disease (MMSE 16-26)
- 6 Month cognitive decline
- Stable marketed AD therapy x2 months or additional marketed AD therapy during study
- Score of <=4 on the Modified Hachinski Ischemia Scale
- CT results consistent with Alzheimer's disease
- Medically stable
Show all 9Show fewer
- 6 years education
- Reliable study partner (caregiver)
- Must be able to swallow capsules
Who cannot join
- Premenopausal women
- Dementia due to other causes than Alzheimer's disease
- History of stroke
- Immunocompromised
- Active peptic ulcer, GI bleed, chronic inflammatory bowel disease, chronic diarrhea or past GI surgery that would impact drug absorption
- Unstable Vitamin B-12 deficiency
Show all 14Show fewer
- Hematologic or solid malignancy within 5 years
- Geriatric Depression Scale >= 6
- Unstable medical condition
- Alcohol or drug abuse history with 12-months of study entry
- Significant drug allergy
- Alzheimer's disease modification experimental therapy with 12 months of study entry
- Prisoners, compulsory psychiatric patients, or residents of nursing home or skilled nursing facility at entry
- Any other experimental therapy with 30-days of study entry
Trial locations and contacts
41 sites in 4 countries.
41 sites in 4 countries
United States35 sites
University Of Alabama At Birmingham
Birmingham, Alabama, 35294
Meridien Research
Brooksville, Florida, 34601
The Ohio State University
Columbus, Ohio, 43210
The University Of Texas
Dallas, Texas, 75390
Brain Matters Research
Delray Beach, Florida, 33445
Professional Neurological Associates, Pc
Dunmore, Pennsylvania, 18512
R.I. Mood & Memory Research Institute
East Providence, Rhode Island, 02914
Memory Enhancement Center Of Amercia, Inc.
Eatontown, New Jersey, 07724
Margolin Brain Institute
Fresno, California, 93720
Collaborative Neuroscience Network, Inc.
Garden Grove, California, 92845
Md Clinical
Hallandale, Florida, 33009
Indiana University Medical Center
Indianapolis, Indiana, 46202
The Clinical Trial Center Llc
Jenkintown, Pennsylvania, 19046
Pacific Institute For Medical Research, Inc.
Los Angeles, California, 90024
Mary S. Easton Center
Los Angeles, California, 90095
Dean Foundation For Health Research & Education
Middleton, Wisconsin, 53562
Yale University School Of Medicine
New Haven, Connecticut, 06510
Columbia University
New York, New York, 10032
Comprehensive Psychiatric Care
Norwich, Connecticut, 06360
Compass Research, Llc
Orlando, Florida, 32806
Four Rivers Clinical Research, Inc
Paducah, Kentucky, 42003
21st Century Neurology
Phoenix, Arizona, 85004
Banner Alzheimer'S Institute
Phoenix, Arizona, 85006
Global Medical Institutes, Llc
Princeton, New Jersey, 08540
Butler Hospital
Providence, Rhode Island, 02906
Richard H. Weisler, Md, Pa & Associates
Raleigh, North Carolina, 27609
University Of Rochester
Rochester, New York, 14620
Pacific Research Network, Inc
San Diego, California, 92103
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, 91403
Miami Research Associates
South Miami, Florida, 33143
Sun Health Research Institue
Sun City, Arizona, 85351
Usf Suncoast Alzheimer'S And Gerontology Center
Tampa, Florida, 33613
Neurology & Neuroscience Center Of Ohio
Toledo, Ohio, 43623
Tulsa Clinical Research, Llc
Tulsa, Oklahoma, 74104
Center For Clinical Trials
Venice, Florida, 34285
Sweden3 sites
Local Institution
Malmö, 212 24
Local Institution
Mölndal, 431 41
Local Institution
Stockholm, 141 86
About this study
Official title: Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacodynamic and Pharmacokinetic Effects of BMS-708163 in the Treatment of Patients With Mild to Moderate Alzheimer's Disease
The purpose of this study is to determine the safety and tolerability of BMS-708163 in patients with mild to moderate Alzheimer's disease over a treatment period of 12-weeks and the course of any potential effects during a 12-week wash-out period
- Conditions
- Alzheimer's Disease
- Being tested
- BMS-708163, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-708163Drug
Capsules, Oral, 25 mg, once daily, 24 weeks
BMS-708163Drug
Capsules, Oral, 50 mg, once daily, 24 weeks
BMS-708163Drug
Capsules, Oral, 100 mg, once daily, 24 weeks
BMS-708163Drug
Capsules, Oral, 125 mg, once daily, 24 weeks
PlaceboDrug
Capsules, Oral, 0 mg, once daily, 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| A1 | Active comparator | Not described Receives: Drug: BMS-708163 |
| A2 | Active comparator | Not described Receives: Drug: BMS-708163 |
| A3 | Active comparator | Not described Receives: Drug: BMS-708163 |
| A4 | Active comparator | Not described Receives: Drug: BMS-708163 |
| A5 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Measured: Weekly for the first 12-weeks of the 24-Week dosing period (Baseline-Week-12) and every 2 weeks during the second 12-weeks of the 24-Week dosing period (Weeks 14-24) and during the subsequent 12-week washout period (Weeks 28, 32, & 36)
Secondary outcomes (8)
Pharmacodynamics effects of Cerebral Spinal Fluid
Measured: Baseline, Week 12 and Week 24
Pharmacodynamics effects of the Alzheimer's Disease Assessment Scale - Cognitive Subscale
Measured: Baseline, Week 12, Week 24 and Week 36
Pharmacodynamics effects of the Alzheimer's Disease Collaborative Study - Activities of Daily Living scale
Measured: Baseline, Week 12, Week 24 and Week 36
Pharmacodynamics effects of the Global clinical impression as assessed with the Clinical Dementia Rating-Sum of Boxes
Measured: Baseline, Week 12, Week 24 and Week 36
Characterize Pharmacodynamics/Pharmacokinetics effects of the plasma exposure of BMS-708163 and variability in a population with Alzheimer's disease
Measured: Baseline, Week 12 and Week 24
Characterize Pharmacodynamics/Pharmacokinetics effects in refining the Pharmacokinetics/Pharmacodynamics model with Phase 2 data
Measured: Baseline, Week 12 and Week 24
Characterize Pharmacodynamics/Pharmacokinetics effects by exploring correlations between exposure, biomarkers, and clinical effects
Measured: Baseline, Week 12 and Week 24
Characterize Pharmacodynamics/Pharmacokinetics effects by exploring Pharmacokinetics variability, including the correlation between polymorphisms of CYP enzymes
Measured: Baseline, Week 12 and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startFeb 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810147
- Sponsor's protocol ID
- CN156-013
- Other IDs
- EUDRACT: 2008-005929-11
- Status last verified
- Sep 2015
- First submitted
- 16 Dec 2008
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Coric V, van Dyck CH, Salloway S, Andreasen N, Brody M, Richter RW, Soininen H, Thein S, Shiovitz T, Pilcher G, Colby S, Rollin L, Dockens R, Pachai C, Portelius E, Andreasson U, Blennow K, Soares H, Albright C, Feldman HH, Berman RM. Safety and tolerability of the gamma-secretase inhibitor avagacestat in a phase 2 study of mild to moderate Alzheimer disease. Arch Neurol. 2012 Nov;69(11):1430-40. doi: 10.1001/archneurol.2012.2194.
PubMed 22892585
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, Pharmacodynamic and Pharmacokinetic Effects of BMS-708163 in the Treatment of Patients With Mild to Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00810147
- Acronym / sponsor ID
- CN156-013
- Conditions
- Alzheimer's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 17 Dec 2008 (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 study is to determine the safety and tolerability of BMS-708163 in patients with mild to moderate Alzheimer's disease over a treatment period of 12-weeks and the course of any potential effects during a 12-week wash-out period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| A1 | Active comparator | Drug: BMS-708163 |
| A2 | Active comparator | Drug: BMS-708163 |
| A3 | Active comparator | Drug: BMS-708163 |
| A4 | Active comparator | Drug: BMS-708163 |
| A5 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Clinical diagnosis of Mild to Moderate Alzheimer's disease (MMSE 16-26)
- 6 Month cognitive decline
- Stable marketed AD therapy x2 months or additional marketed AD therapy during study
- Score of <=4 on the Modified Hachinski Ischemia Scale
- CT results consistent with Alzheimer's disease
Key exclusion criteria (14 listed)
- Premenopausal women
- Dementia due to other causes than Alzheimer's disease
- History of stroke
- Immunocompromised
- Active peptic ulcer, GI bleed, chronic inflammatory bowel disease, chronic diarrhea or past GI surgery that would impact drug absorption
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 |
|---|---|---|
| BMS-708163Capsules, Oral, 25 mg, once daily, 24 weeks | Drug | A1 |
| BMS-708163Capsules, Oral, 50 mg, once daily, 24 weeks | Drug | A2 |
| BMS-708163Capsules, Oral, 100 mg, once daily, 24 weeks | Drug | A3 |
| BMS-708163Capsules, Oral, 125 mg, once daily, 24 weeks | Drug | A4 |
| PlaceboCapsules, Oral, 0 mg, once daily, 24 weeks | Drug | A5 |
Primary outcome
Adverse Events
Time frame: Weekly for the first 12-weeks of the 24-Week dosing period (Baseline-Week-12) and every 2 weeks during the second 12-weeks of the 24-Week dosing period (Weeks 14-24) and during the subsequent 12-week washout period (Weeks 28, 32, & 36)
8 secondary outcomes
Pharmacodynamics effects of Cerebral Spinal Fluid
Time frame: Baseline, Week 12 and Week 24
Pharmacodynamics effects of the Alzheimer's Disease Assessment Scale - Cognitive Subscale
Time frame: Baseline, Week 12, Week 24 and Week 36
Pharmacodynamics effects of the Alzheimer's Disease Collaborative Study - Activities of Daily Living scale
Time frame: Baseline, Week 12, Week 24 and Week 36
Pharmacodynamics effects of the Global clinical impression as assessed with the Clinical Dementia Rating-Sum of Boxes
Time frame: Baseline, Week 12, Week 24 and Week 36
Characterize Pharmacodynamics/Pharmacokinetics effects of the plasma exposure of BMS-708163 and variability in a population with Alzheimer's disease
Time frame: Baseline, Week 12 and Week 24
Characterize Pharmacodynamics/Pharmacokinetics effects in refining the Pharmacokinetics/Pharmacodynamics model with Phase 2 data
Time frame: Baseline, Week 12 and Week 24
Characterize Pharmacodynamics/Pharmacokinetics effects by exploring correlations between exposure, biomarkers, and clinical effects
Time frame: Baseline, Week 12 and Week 24
Characterize Pharmacodynamics/Pharmacokinetics effects by exploring Pharmacokinetics variability, including the correlation between polymorphisms of CYP enzymes
Time frame: Baseline, Week 12 and Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
- Derived from this study: PubMed 22892585Coric V, van Dyck CH, Salloway S, Andreasen N, Brody M, Richter RW, Soininen H, Thein S, Shiovitz T, Pilcher G, Colby S, Rollin L, Dockens R, Pachai C, Portelius E, Andreasson U, Blennow K, Soares H, Albright C, Feldman HH, Berman RM. Safety and tolerability of the gamma-secretase inhibitor avagacestat in a phase 2 study of mild to moderate Alzheimer disease. Arch Neurol. 2012 Nov;69(11):1430-40. doi: 10.1001/archneurol.2012.2194.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
41 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMS-708163 in people with Alzheimer's Disease, run by Bristol-Myers Squibb at 41 sites in 4 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 9 inclusion and 14 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: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Sweden, Finland, Denmark. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse Events (time frame: Weekly for the first 12-weeks of the 24-Week dosing period (Baseline-Week-12) and every 2 weeks during the second 12-weeks of the 24-Week dosing period (Weeks 14-24) and during the subsequent 12-week washout period (Weeks 28, 32, & 36)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00810147, which also lists 1 linked publication.
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 12 Oct 2015.