Study to Evaluate the Safety, Tolerability and the Effect of BMS-241027 on Cerebrospinal Fluid Biomarkers in Subjects With Mild Alzheimer's Disease

July 23, 2014 updated by: Bristol-Myers Squibb

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and the Effect of BMS-241027 on Cerebrospinal Fluid Biomarkers in Subjects With Mild Alzheimer's Disease

The purpose of the study is to evaluate safety and the pharmacodynamic effects of BMS-241027 on cerebrospinal fluid (CSF) Tau, connectivity magnetic resonance imaging (MRI), and computerized cognitive tests in mild Alzheimer's disease (AD) subjects, following 9 weekly intravenous (IV) infusions of BMS-241027

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.
40

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 1

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

  • Canada
    • Ontario
      • London, Ontario, Canada, N6C 5J1
        • Local Institution
      • Toronto, Ontario, Canada, M3B 2S7
        • Local Institution
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2J2
        • Local Institution
  • France
      • Lille Cedex, France, 59037
        • Local Institution
      • Paris, France, 75013
        • Local Institution
    • Cedex 9
      • Toulouse, Cedex 9, France, 31059
        • Local Institution
  • Germany
      • Berlin, Germany, 14050
        • Local Institution
      • Heidelberg, Germany, 69115
        • Local Institution
  • Sweden
      • Stockholm, Sweden, 141 86
        • Local Institution
  • United States
    • California
      • Anaheim, California, United States, 92801
        • Anaheim Clinical Trials Llc
      • Long Beach, California, United States, 90806
      • San Francisco, California, United States, 94158
        • UCSF Memory and Aging Center
    • Colorado
      • Boulder, Colorado, United States, 80304
        • Alpine Clinical Research Center, Inc.
    • Connecticut
      • Fairfield, Connecticut, United States, 06824
        • Associated Neurologists of Southern Connecticut, P.C.
    • Florida
      • Orlando, Florida, United States, 32806
        • Compass Research, LLC
      • Palm Beach Gardens, Florida, United States, 33410
        • Palm Beach Neurological Center Advanced Research Consultants
    • Illinois
      • Elk Grove Village, Illinois, United States, 60007
        • Alexian Brothers Neurosciences Institute Clinical Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
    • Michigan
      • East Lansing, Michigan, United States, 48824
        • Michigan State University
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
        • The Clinical Trial Center, LLC
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn Memory Center
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Lifetree Clinical Research

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

46 years to 86 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Mild AD Subjects meeting National Institute of Neurological Disorders and Stroke - Alzheimer's Disease Related Disorders Association(NINCDS-ADRDA) and Diagnostic and Statistical Manual of Mental Disorders-Forth Edition, Text Revision (DSM-IV-TR) criteria
  • Mini-Mental State Exam (MMSE) Score between 20 & 26 (inclusive)
  • CSF consistent with AD pathology
  • Screening brain MRI - normal - commensurate with age or demonstrate atrophy consistent with AD diagnosis (dx); reveal no more than mild white matter disease; up to 2 lacunar infarcts acceptable except in anterior thalamus, genu of internal capsule or basal forebrain; reveal no cortical infarcts; reveal no more than 4 microbleeds; reveal no focal asymmetric lobar atrophy or other findings suggesting primary cause of dementia is attributed to a cause other than AD; reveal no macrohemorrhages (>10 mm)
  • Subjects must have reliable study partners
  • Men and Women of Non Child Bearing Potentia (WONCBP), ages 50-90 years

Exclusion Criteria:

  • Subjects with any other medical condition other than mild AD that could explain subjects' memory or cognitive deficits
  • Subjects diagnosed with moderate or severe AD per DSM-IV criteria
  • Subjects with a history (hx) of stroke
  • Subjects with a hx of GI illnesses
  • Subjects with Vitamin B12 or folate deficiency
  • Subjects with any unstable cardiovascular (CV), pulmonary, Gastrointestinal (GI) or hepatic disease within 30 days prior to screening
  • Subjects with active liver dx or history of hepatic intolerance
  • Subjects with a Geriatric Depression Scale score of ≥ 6 at screening
  • Subjects treated for or have had a diagnosis of schizophrenia
  • Subjects treated for or have had a diagnosis of bipolar disease within 3 years prior to screening
  • Subjects with a history of generalized peripheral neuropathy

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.
Experimental: Arm 1: BMS-241027 (0.003 mg/kg)
Drug: BMS-241027
Intravenous (IV), 0.003 mg/kg, Once Weekly, 9 weeks
Drug: BMS-241027
Intravenous (IV), 0.01 mg/kg, Once Weekly, 9 weeks
Drug: BMS-241027
Intravenous (IV), 0.03 mg/kg, Once Weekly, 9 weeks
Experimental: Arm 2: BMS-241027 (0.01 mg/kg)
Drug: BMS-241027
Intravenous (IV), 0.003 mg/kg, Once Weekly, 9 weeks
Drug: BMS-241027
Intravenous (IV), 0.01 mg/kg, Once Weekly, 9 weeks
Drug: BMS-241027
Intravenous (IV), 0.03 mg/kg, Once Weekly, 9 weeks
Experimental: Arm 3: BMS-241027 (0.03 mg/kg)
Drug: BMS-241027
Intravenous (IV), 0.003 mg/kg, Once Weekly, 9 weeks
Drug: BMS-241027
Intravenous (IV), 0.01 mg/kg, Once Weekly, 9 weeks
Drug: BMS-241027
Intravenous (IV), 0.03 mg/kg, Once Weekly, 9 weeks
Experimental: Arm 4: Placebo matching BMS-241027
Drug: Placebo matching BMS-241027
Intravenous (IV), 0.0 mg/kg, Once Weekly, 9 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
Safety assessments: based on frequency of Serious Adverse Events (SAEs), frequency of Adverse events (AEs), discontinuation due to AEs and dose reduction
Time Frame: Within the first 70 day after first dose
Within the first 70 day after first dose
Biomarker Measures: CSF levels of Tau N-terminal domain fragments
Time Frame: Within the first 70 day after first dose
Within the first 70 day after first dose

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
Measure Description
Time Frame
Effects of BMS-241027 on CSF levels of the mid-domain Tau fragment
Time Frame: Within the first 70 days after first dose
Within the first 70 days after first dose
Effects of BMS-241027 on cognitive performance using computerized cognitive tests
Time Frame: Weeks 3, 6 and 9
Weeks 3, 6 and 9
Effects of BMS-241027 on connectivity MRI
Time Frame: Within the first 70 days after first dose
Within the first 70 days after first dose
Maximal observed plasma concentration (Cmax) of BMS-241027 in subjects with mild Alzheimer's disease
Time Frame: Weeks 1, 4, and 9
Intensive pharmacokinetic parameter Cmax will be derived from subgroups of subjects at Week 7
Weeks 1, 4, and 9
Observed plasma concentration at 24 hours post dose (C24) of BMS-241027 in subjects with mild Alzheimer's disease
Time Frame: Weeks 1, 4, and 9
Intensive pharmacokinetic parameter C24 will be derived from subgroups of subjects at Week 7
Weeks 1, 4, and 9
Time of maximal observed plasma concentration (Tmax) of BMS-241027 in subjects with mild Alzheimer's disease
Time Frame: Weeks 1, 4, and 9
Intensive pharmacokinetic parameter Tmax will be derived from subgroups of subjects at Week 7
Weeks 1, 4, and 9
Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-241027 in subjects with mild Alzheimer's disease
Time Frame: Weeks 1, 4, and 9
Intensive pharmacokinetic parameter AUC(TAU) will be derived from subgroups of subjects at Week 7
Weeks 1, 4, and 9
Safety assessments: based on vital sign measurements, ECGs and clinical laboratory tests
Time Frame: Within the first 70 day after first dose
Within the first 70 day after first dose
Effects of BMS-241027 on CSF levels of neurofilaments
Time Frame: Within the first 70 days after first dose
Within the first 70 days after first dose

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.

Helpful Links

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, 2012

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.
October 1, 2013

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.
October 1, 2013

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 13, 2011

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 13, 2011

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 15, 2011

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.
July 24, 2014

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.
July 23, 2014

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.
October 1, 2013

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.
  • CN167-003
  • 2011-004065-33 (EudraCT Number)

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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