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A Multicenter, Double Blind, Placebo-Controlled, Safety and Tolerability Study of BMS-708163 in Patients With Prodromal Alzheimer's Disease

Primary Purpose

Alzheimer's Disease

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Avagacestat
Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

45 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 6 years education
  • Reliable study partner
  • Must be able to swallow capsules

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • University Of Alabama At Birmingham
  • Pivotal Research Centers
  • 21st Century Neurology
  • Banner Alzheimer'S Institute
  • Sun Health Research Institue
  • Margolin Brain Institute
  • Collaborative Neuroscience Network, Inc.
  • Mary S. Easton Center
  • Pharmacology Research Institute
  • Uc Irvine Medical Center
  • Pacific Research Network
  • Affiliated Research Institute
  • University Of California, San Diego
  • California Neuroscience Research Medical Group, Inc.
  • Radiant Research, Inc.
  • Yale University School Of Medicine
  • Comprehensive Psychiatric Care
  • Meridien Research
  • Brain Matters Research
  • Md Clinical
  • Compass Research, Llc
  • Indiana University Medical Center
  • Four Rivers Clinical Research, Inc
  • Brigham & Women'S Hospital
  • St Louis University
  • Washington University School Of Medicine
  • Cleveland Clinic Lou Ruvo Center For Brain Health
  • Memory Enhancement Center Of Amercia, Inc.
  • Robert Wood Johnson Medical School, Umdnj
  • Global Medical Institutes, Llc
  • Memory Enhancement Center Of Nj, Inc.
  • Spri Clinical Trials, Llc
  • Nyu Langone Medical Center
  • Columbia University
  • University Of Rochester Medical Center
  • Duke University Medical Center
  • Raleigh Neurology Associates, Pa
  • Richard H. Weisler, Md, Pa & Assoc.
  • Clinical Trials Of America, Inc.
  • Wake Forest University School Of Medicine
  • The Ohio State University
  • Neurology & Neuroscience Center Of Ohio
  • Tulsa Clinical Research, Llc
  • Providence Cognitive Assessment Clinic
  • Oregon Health & Science University
  • Butler Hospital
  • Senior Adults Specialty Research (Sasr)
  • The University Of Texas
  • Dean Foundation For Health Research & Education
  • Mcw Clinics At Froedtert Hospital
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Avagacestat (50 mg)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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
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
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
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

Secondary Outcome Measures

Predictive value of Cerebral Spinal Fluid (CSF) biomarkers (Aβ40, and Aβ42, total Tau, total Tau/Aβ42 ratio, phosphorylated Tau) on progression to dementia

Full Information

First Posted
April 29, 2009
Last Updated
September 23, 2015
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00890890
Brief Title
A Multicenter, Double Blind, Placebo-Controlled, Safety and Tolerability Study of BMS-708163 in Patients With Prodromal Alzheimer's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Study Start Date
May 2009 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
263 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Avagacestat (50 mg)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Avagacestat
Other Intervention Name(s)
BMS-708163
Intervention Description
Capsules, Oral, 50 mg, once daily, 104 - 220 Weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsules, Oral, 0 mg, once daily, 104 - 220 Weeks
Primary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 6 years education Reliable study partner Must be able to swallow capsules Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
University Of Alabama At Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Pivotal Research Centers
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
21st Century Neurology
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Banner Alzheimer'S Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Sun Health Research Institue
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Margolin Brain Institute
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Collaborative Neuroscience Network, Inc.
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Mary S. Easton Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Pharmacology Research Institute
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Uc Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Pacific Research Network
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Affiliated Research Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
University Of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
California Neuroscience Research Medical Group, Inc.
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Facility Name
Radiant Research, Inc.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80239
Country
United States
Facility Name
Yale University School Of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Comprehensive Psychiatric Care
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Meridien Research
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34601
Country
United States
Facility Name
Brain Matters Research
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Md Clinical
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Compass Research, Llc
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Indiana University Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Four Rivers Clinical Research, Inc
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Brigham & Women'S Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
St Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Washington University School Of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Cleveland Clinic Lou Ruvo Center For Brain Health
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Memory Enhancement Center Of Amercia, Inc.
City
Eatontown
State/Province
New Jersey
ZIP/Postal Code
07724
Country
United States
Facility Name
Robert Wood Johnson Medical School, Umdnj
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Global Medical Institutes, Llc
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Memory Enhancement Center Of Nj, Inc.
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Spri Clinical Trials, Llc
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Nyu Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University Of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Raleigh Neurology Associates, Pa
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Richard H. Weisler, Md, Pa & Assoc.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Clinical Trials Of America, Inc.
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Wake Forest University School Of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Neurology & Neuroscience Center Of Ohio
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Tulsa Clinical Research, Llc
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Providence Cognitive Assessment Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Senior Adults Specialty Research (Sasr)
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
The University Of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Dean Foundation For Health Research & Education
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States
Facility Name
Mcw Clinics At Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Local Institution
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Local Institution
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2B5
Country
Canada
Facility Name
Local Institution
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 5J1
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
Local Institution
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
Facility Name
Local Institution
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Local Institution
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
Local Institution
City
Toulouse
State/Province
Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Local Institution
City
Bordeaux Cedex
ZIP/Postal Code
33076
Country
France
Facility Name
Local Institution
City
Dijon
ZIP/Postal Code
21033
Country
France
Facility Name
Local Institution
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Local Institution
City
Rennes Cedex 9
ZIP/Postal Code
35033
Country
France
Facility Name
Local Institution
City
Molndal
ZIP/Postal Code
431 41
Country
Sweden
Facility Name
Local Institution
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
26414022
Citation
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.
Results Reference
derived
Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource

Learn more about this trial

A Multicenter, Double Blind, Placebo-Controlled, Safety and Tolerability Study of BMS-708163 in Patients With Prodromal Alzheimer's Disease

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