NCT01492374

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2012

Geographic Reach
5 countries

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 15, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

July 24, 2014

Status Verified

October 1, 2013

Enrollment Period

1.7 years

First QC Date

December 13, 2011

Last Update Submit

July 23, 2014

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (2)

  • Safety assessments: based on frequency of Serious Adverse Events (SAEs), frequency of Adverse events (AEs), discontinuation due to AEs and dose reduction

    Within the first 70 day after first dose

  • Biomarker Measures: CSF levels of Tau N-terminal domain fragments

    Within the first 70 day after first dose

Secondary Outcomes (9)

  • Effects of BMS-241027 on CSF levels of the mid-domain Tau fragment

    Within the first 70 days after first dose

  • Effects of BMS-241027 on cognitive performance using computerized cognitive tests

    Weeks 3, 6 and 9

  • Effects of BMS-241027 on connectivity MRI

    Within the first 70 days after first dose

  • Maximal observed plasma concentration (Cmax) of BMS-241027 in subjects with mild Alzheimer's disease

    Weeks 1, 4, and 9

  • Observed plasma concentration at 24 hours post dose (C24) of BMS-241027 in subjects with mild Alzheimer's disease

    Weeks 1, 4, and 9

  • +4 more secondary outcomes

Study Arms (4)

Arm 1: BMS-241027 (0.003 mg/kg)

EXPERIMENTAL
Drug: BMS-241027

Arm 2: BMS-241027 (0.01 mg/kg)

EXPERIMENTAL
Drug: BMS-241027

Arm 3: BMS-241027 (0.03 mg/kg)

EXPERIMENTAL
Drug: BMS-241027

Arm 4: Placebo matching BMS-241027

EXPERIMENTAL
Drug: Placebo matching BMS-241027

Interventions

BMS-241027DRUG

Intravenous (IV), 0.003 mg/kg, Once Weekly, 9 weeks

Arm 1: BMS-241027 (0.003 mg/kg)
Placebo matching BMS-241027DRUG

Intravenous (IV), 0.0 mg/kg, Once Weekly, 9 weeks

Arm 4: Placebo matching BMS-241027

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Anaheim Clinical Trials Llc

Anaheim, California, 92801, United States

Location

Unknown Facility

Long Beach, California, 90806, United States

Location

Ucsf Memory And Aging Center

San Francisco, California, 94158, United States

Location

Alpine Clinical Research Center, Inc.

Boulder, Colorado, 80304, United States

Location

Associated Neurologists Of Southern Connecticut, P.C.

Fairfield, Connecticut, 06824, United States

Location

Compass Research, Llc

Orlando, Florida, 32806, United States

Location

Palm Beach Neurological Center Advanced Research Consultants

Palm Beach Gardens, Florida, 33410, United States

Location

Alexian Brothers Neurosciences Institute Clinical Research

Elk Grove Village, Illinois, 60007, United States

Location

Brigham And Women'S Hospital

Boston, Massachusetts, 02115, United States

Location

Michigan State University

East Lansing, Michigan, 48824, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

The Clinical Trial Center, Llc

Jenkintown, Pennsylvania, 19046, United States

Location

Hospital Of The University Of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Penn Memory Center

Philadelphia, Pennsylvania, 19104, United States

Location

Lifetree Clinical Research

Salt Lake City, Utah, 84106, United States

Location

Local Institution

London, Ontario, N6C 5J1, Canada

Location

Local Institution

Toronto, Ontario, M3B 2S7, Canada

Location

Local Institution

Greenfield Park, Quebec, J4V 2J2, Canada

Location

Local Institution

Toulouse, Cedex 9, 31059, France

Location

Local Institution

Lille, 59037, France

Location

Local Institution

Paris, 75013, France

Location

Local Institution

Berlin, 14050, Germany

Location

Local Institution

Heidelberg, 69115, Germany

Location

Local Institution

Stockholm, 141 86, Sweden

Location

Related Links

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2011

First Posted

December 15, 2011

Study Start

February 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

July 24, 2014

Record last verified: 2013-10

Locations

FR(3)DE(2)SE(1)CA(3)US(15)