A Phase II, Multicenter, Double Blind, Placebo-Controlled Safety, Tolerability Study of BMS-708163 in Patients With Mild to Moderate Alzheimer's Disease

September 23, 2015 updated by: Bristol-Myers Squibb

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
209

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Local Institution
  • Finland
      • Kuopio, Finland, 70210
        • Local Institution
      • Turku, Finland, 20520
        • Local Institution
  • Sweden
      • Malmo, Sweden, 212 24
        • Local Institution
      • Molndal, Sweden, 431 41
        • Local Institution
      • Stockholm, Sweden, 141 86
        • Local Institution
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner Alzheimer's Institute
      • Phoenix, Arizona, United States, 85004
        • 21st Century Neurology
      • Sun City, Arizona, United States, 85351
        • Sun Health Research Institue
    • California
      • Fresno, California, United States, 93720
        • Margolin Brain Institute
      • Garden Grove, California, United States, 92845
        • Collaborative Neuroscience Network, Inc.
      • Los Angeles, California, United States, 90024
        • Pacific Institute For Medical Research, Inc.
      • Los Angeles, California, United States, 90095
        • Mary S. Easton Center
      • San Diego, California, United States, 92103
        • Pacific Research Network, Inc
      • Sherman Oaks, California, United States, 91403
        • California Neuroscience Research Medical Group, Inc.
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University School Of Medicine
      • Norwich, Connecticut, United States, 06360
        • Comprehensive Psychiatric Care
    • Florida
      • Brooksville, Florida, United States, 34601
        • Meridien Research
      • Delray Beach, Florida, United States, 33445
        • Brain Matters Research
      • Hallandale Beach, Florida, United States, 33009
        • MD Clinical
      • Orlando, Florida, United States, 32806
        • Compass Research, LLC
      • South Miami, Florida, United States, 33143
        • Miami Research Associates
      • Tampa, Florida, United States, 33613
        • Usf Suncoast Alzheimer'S And Gerontology Center
      • Venice, Florida, United States, 34285
        • Center for Clinical Trials
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Medical Center
    • Kentucky
      • Paducah, Kentucky, United States, 42003
        • Four Rivers Clinical Research, Inc
    • New Jersey
      • Eatontown, New Jersey, United States, 07724
        • Memory Enhancement Center Of Amercia, Inc.
      • Princeton, New Jersey, United States, 08540
        • Global Medical Institutes, LLC
    • New York
      • New York, New York, United States, 10032
        • Columbia University
      • Rochester, New York, United States, 14620
        • University of Rochester
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Richard H. Weisler, MD, PA & Associates
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
      • Toledo, Ohio, United States, 43623
        • Neurology & Neuroscience Center Of Ohio
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Tulsa Clinical Research, LLC
    • Pennsylvania
      • Dunmore, Pennsylvania, United States, 18512
        • Professional Neurological Associates, Pc
      • Jenkintown, Pennsylvania, United States, 19046
        • The Clinical Trial Center LLC
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • R.I. Mood & Memory Research Institute
      • Providence, Rhode Island, United States, 02906
        • Butler Hospital
    • Texas
      • Dallas, Texas, United States, 75390
        • The University of Texas
    • Wisconsin
      • Middleton, Wisconsin, United States, 53562
        • Dean Foundation For Health Research & Education

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: A1
Drug: BMS-708163
Capsules, Oral, 25 mg, once daily, 24 weeks
Drug: BMS-708163
Capsules, Oral, 50 mg, once daily, 24 weeks
Drug: BMS-708163
Capsules, Oral, 100 mg, once daily, 24 weeks
Drug: BMS-708163
Capsules, Oral, 125 mg, once daily, 24 weeks
Active Comparator: A2
Drug: BMS-708163
Capsules, Oral, 25 mg, once daily, 24 weeks
Drug: BMS-708163
Capsules, Oral, 50 mg, once daily, 24 weeks
Drug: BMS-708163
Capsules, Oral, 100 mg, once daily, 24 weeks
Drug: BMS-708163
Capsules, Oral, 125 mg, once daily, 24 weeks
Active Comparator: A3
Drug: BMS-708163
Capsules, Oral, 25 mg, once daily, 24 weeks
Drug: BMS-708163
Capsules, Oral, 50 mg, once daily, 24 weeks
Drug: BMS-708163
Capsules, Oral, 100 mg, once daily, 24 weeks
Drug: BMS-708163
Capsules, Oral, 125 mg, once daily, 24 weeks
Placebo Comparator: A5
Drug: Placebo
Capsules, Oral, 0 mg, once daily, 24 weeks
Active Comparator: A4
Drug: BMS-708163
Capsules, Oral, 25 mg, once daily, 24 weeks
Drug: BMS-708163
Capsules, Oral, 50 mg, once daily, 24 weeks
Drug: BMS-708163
Capsules, Oral, 100 mg, once daily, 24 weeks
Drug: BMS-708163
Capsules, Oral, 125 mg, once daily, 24 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Pharmacodynamics effects of Cerebral Spinal Fluid
Time Frame: Baseline, Week 12 and Week 24
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
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
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
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
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
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
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
Baseline, Week 12 and Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 12, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CN156-013
  • EUDRACT: 2008-005929-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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