Alzheimer's DiseasePhase 2NCT00890890
A Multicenter, Double Blind, Placebo-Controlled, Safety and Tolerability Study of BMS-708163 in Patients With Prodromal Alzheimer's Disease
A Phase 2 study testing Avagacestat in people with Alzheimer's Disease, run by Bristol-Myers Squibb at 64 sites in 6 countries.
Trial summary
The purpose of this study is to determine the safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease over a treatment period of a minimum of 104-weeks. In addition patients will be seen for safety visits at 4 and 12 weeks post treatment. Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Avagacestat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 263 participants
- Where
- 64 sitesin 6 countries
- Study dates
- May 2009to Jul 2013
- 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 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient meets clinical criteria for prodromal Alzheimer's disease (MMSE 24-30)
- Memory complaint by subject or study partner
- CSF aβ42 levels < 200pg/mL or Total Tau/aβ42 ratio of ≥ 0.39
- 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
- Must be able to swallow capsules
Who cannot join
- Premenopausal women
- DSM-IV diagnosis of Dementia 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
- Hematologic or solid malignancy within 5 years
Show all 12Show fewer
- Geriatric Depression Scale ≥ 6
- Unstable medical condition
- Alcohol or drug abuse history with 12-months of study entry
- Significant drug allergy
- 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
64 sites in 6 countries.
64 sites in 6 countries
United States50 sites
Senior Adults Specialty Research (Sasr)
Austin, Texas, 78757
University Of Alabama At Birmingham
Birmingham, Alabama, 35294
Brigham & Women'S Hospital
Boston, Massachusetts, 02115
Spri Clinical Trials, Llc
Brooklyn, New York, 11235
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
Radiant Research, Inc.
Denver, Colorado, 80239
Duke University Medical Center
Durham, North Carolina, 27710
Memory Enhancement Center Of Amercia, Inc.
Eatontown, New Jersey, 07724
Margolin Brain Institute
Fresno, California, 93720
Md Clinical
Hallandale, Florida, 33009
Indiana University Medical Center
Indianapolis, Indiana, 46202
Cleveland Clinic Lou Ruvo Center For Brain Health
Las Vegas, Nevada, 89106
Collaborative Neuroscience Network, Inc.
Long Beach, California, 90806
Mary S. Easton Center
Los Angeles, California, 90095
Dean Foundation For Health Research & Education
Middleton, Wisconsin, 53562
Mcw Clinics At Froedtert Hospital
Milwaukee, Wisconsin, 53226
Robert Wood Johnson Medical School, Umdnj
New Brunswick, New Jersey, 08903
Yale University School Of Medicine
New Haven, Connecticut, 06510
Nyu Langone Medical Center
New York, New York, 10016
Columbia University
New York, New York, 10032
Pharmacology Research Institute
Newport Beach, California, 92660
Comprehensive Psychiatric Care
Norwich, Connecticut, 06360
Uc Irvine Medical Center
Orange, California, 92868
Compass Research, Llc
Orlando, Florida, 32806
Four Rivers Clinical Research, Inc
Paducah, Kentucky, 42003
Pivotal Research Centers
Peoria, Arizona, 85381
21st Century Neurology
Phoenix, Arizona, 85004
Banner Alzheimer'S Institute
Phoenix, Arizona, 85006
Providence Cognitive Assessment Clinic
Portland, Oregon, 97225
Oregon Health & Science University
Portland, Oregon, 97239
Global Medical Institutes, Llc
Princeton, New Jersey, 08540
Butler Hospital
Providence, Rhode Island, 02906
Raleigh Neurology Associates, Pa
Raleigh, North Carolina, 27607
Richard H. Weisler, Md, Pa & Assoc.
Raleigh, North Carolina, 27609
University Of Rochester Medical Center
Rochester, New York, 14642
Pacific Research Network
San Diego, California, 92103
Affiliated Research Institute
San Diego, California, 92108
University Of California, San Diego
San Diego, California, 92161
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, 91403
St Louis University
St Louis, Missouri, 63104
Washington University School Of Medicine
St Louis, Missouri, 63108
Sun Health Research Institue
Sun City, Arizona, 85351
Neurology & Neuroscience Center Of Ohio
Toledo, Ohio, 43623
Memory Enhancement Center Of Nj, Inc.
Toms River, New Jersey, 08755
Tulsa Clinical Research, Llc
Tulsa, Oklahoma, 74104
Clinical Trials Of America, Inc.
Winston-Salem, North Carolina, 27103
Wake Forest University School Of Medicine
Winston-Salem, North Carolina, 27157
Canada5 sites
Local Institution
Calgary, Alberta, T2N 4Z6
Local Institution
Greenfield Park, Quebec, J4V 2J2
Local Institution
London, Ontario, N6C 5J1
Local Institution
Toronto, Ontario, M5T 2S8
Local Institution
Vancouver, British Columbia, V6T 2B5
France5 sites
Local Institution
Bordeaux, 33076
Local Institution
Dijon, 21033
Local Institution
Nantes, 44093
Local Institution
Rennes, 35033
Local Institution
Toulouse, Cedex 9, 31059
Sweden2 sites
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 Prodromal Alzheimer's Disease
The purpose of this study is to determine the safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease over a treatment period of a minimum of 104-weeks. In addition patients will be seen for safety visits at 4 and 12 weeks post treatment.
- Conditions
- Alzheimer's Disease
- Being tested
- Avagacestat, 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.
AvagacestatDrug
Also called BMS-708163
Capsules, Oral, 50 mg, once daily, 104 - 220 Weeks
PlaceboDrug
Capsules, Oral, 0 mg, once daily, 104 - 220 Weeks
| Study group | Role | What they receive |
|---|---|---|
| Avagacestat (50 mg) | Experimental | Not described Receives: Drug: Avagacestat |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease as measured by adverse events, vital signs, laboratory assessments, electrocardiograms (ECGs) and Safety Head Magnetic resonance imaging (MRI) findings
Measured: Every 12 weeks up to week 220
Safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease as measured by adverse events, vital signs, laboratory assessments, electrocardiograms (ECGs) and Safety Head Magnetic resonance imaging (MRI) findings
Measured: Avagacestat-treated patients will be seen for safety visits at 4 Post Treatment/Study Termination
Safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease as measured by adverse events, vital signs, laboratory assessments, electrocardiograms (ECGs) and Safety Head Magnetic resonance imaging (MRI) findings
Measured: Avagacestat-treated patients will be seen for safety visits at 12 Post Treatment/Study Termination
Safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease as measured by adverse events, vital signs, laboratory assessments, electrocardiograms (ECGs) and Safety Head Magnetic resonance imaging (MRI) findings
Measured: Avagacestat-treated patients will have a 24 week post treatment skin examination by a dermatologist
Secondary outcomes (1)
Predictive value of Cerebral Spinal Fluid (CSF) biomarkers (Aβ40, and Aβ42, total Tau, total Tau/Aβ42 ratio, phosphorylated Tau) on progression to dementia
Measured: Baseline (Week 0), Week 2 (optional), Week 24 and Week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionJul 2013
- Study completionJul 2013
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
- 263 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
- NCT00890890
- Sponsor's protocol ID
- CN156-018
- Other IDs
- 2009-010067-16, 2009
- Status last verified
- Sep 2015
- First submitted
- 29 Apr 2009
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Coric V, Salloway S, van Dyck CH, Dubois B, Andreasen N, Brody M, Curtis C, Soininen H, Thein S, Shiovitz T, Pilcher G, Ferris S, Colby S, Kerselaers W, Dockens R, Soares H, Kaplita S, Luo F, Pachai C, Bracoud L, Mintun M, Grill JD, Marek K, Seibyl J, Cedarbaum JM, Albright C, Feldman HH, Berman RM. Targeting Prodromal Alzheimer Disease With Avagacestat: A Randomized Clinical Trial. JAMA Neurol. 2015 Nov;72(11):1324-33. doi: 10.1001/jamaneurol.2015.0607.
PubMed 26414022
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 Prodromal Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00890890
- Acronym / sponsor ID
- CN156-018
- Conditions
- Alzheimer's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 30 Apr 2009 (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 Prodromal Alzheimer's disease over a treatment period of a minimum of 104-weeks. In addition patients will be seen for safety visits at 4 and 12 weeks post treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Avagacestat (50 mg) | Experimental | Drug: Avagacestat |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient meets clinical criteria for prodromal Alzheimer's disease (MMSE 24-30)
- Memory complaint by subject or study partner
- CSF aβ42 levels < 200pg/mL or Total Tau/aβ42 ratio of ≥ 0.39
- Score of ≤4 on the Modified Hachinski Ischemia Scale
- CT results consistent with Alzheimer's disease
Key exclusion criteria (12 listed)
- Premenopausal women
- DSM-IV diagnosis of Dementia 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
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 |
|---|---|---|
| AvagacestatAlso: BMS-708163Capsules, Oral, 50 mg, once daily, 104 - 220 Weeks | Drug | Avagacestat (50 mg) |
| PlaceboCapsules, Oral, 0 mg, once daily, 104 - 220 Weeks | Drug | Placebo |
Primary outcome
Safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease as measured by adverse events, vital signs, laboratory assessments, electrocardiograms (ECGs) and Safety Head Magnetic resonance imaging (MRI) findings
Time frame: Every 12 weeks up to week 220
Safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease as measured by adverse events, vital signs, laboratory assessments, electrocardiograms (ECGs) and Safety Head Magnetic resonance imaging (MRI) findings
Time frame: Avagacestat-treated patients will be seen for safety visits at 4 Post Treatment/Study Termination
Safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease as measured by adverse events, vital signs, laboratory assessments, electrocardiograms (ECGs) and Safety Head Magnetic resonance imaging (MRI) findings
Time frame: Avagacestat-treated patients will be seen for safety visits at 12 Post Treatment/Study Termination
Safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease as measured by adverse events, vital signs, laboratory assessments, electrocardiograms (ECGs) and Safety Head Magnetic resonance imaging (MRI) findings
Time frame: Avagacestat-treated patients will have a 24 week post treatment skin examination by a dermatologist
1 secondary outcome
Predictive value of Cerebral Spinal Fluid (CSF) biomarkers (Aβ40, and Aβ42, total Tau, total Tau/Aβ42 ratio, phosphorylated Tau) on progression to dementia
Time frame: Baseline (Week 0), Week 2 (optional), Week 24 and Week 104
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
- Derived from this study: PubMed 26414022Coric V, Salloway S, van Dyck CH, Dubois B, Andreasen N, Brody M, Curtis C, Soininen H, Thein S, Shiovitz T, Pilcher G, Ferris S, Colby S, Kerselaers W, Dockens R, Soares H, Kaplita S, Luo F, Pachai C, Bracoud L, Mintun M, Grill JD, Marek K, Seibyl J, Cedarbaum JM, Albright C, Feldman HH, Berman RM. Targeting Prodromal Alzheimer Disease With Avagacestat: A Randomized Clinical Trial. JAMA Neurol. 2015 Nov;72(11):1324-33. doi: 10.1001/jamaneurol.2015.0607.
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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
64 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Avagacestat in people with Alzheimer's Disease, run by Bristol-Myers Squibb at 64 sites in 6 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 12 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: stopped early, 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 64 sites in United States, Canada, France, Sweden, Denmark and 1 more country. 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 was stopped early. 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?
Safety and tolerability of BMS-708163 in patients with Prodromal Alzheimer's disease as measured by adverse events, vital signs, laboratory assessments, electrocardiograms (ECGs) and Safety Head Magnetic resonance imaging (MRI) findings (time frame: Every 12 weeks up to week 220). The study lists 4 primary outcomes in all. 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 NCT00890890, 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.