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Alzheimer's DiseasePhase 1NCT01492374

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

A Phase 1 study testing BMS-241027 in people with Alzheimer's Disease, run by Bristol-Myers Squibb at 24 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 50 to 90 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
BMS-241027
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
24 sitesin 5 countries
Study dates
Feb 2012to Oct 2013
Phase
Phase 1
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 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

24 sites in 5 countries.

24 sites in 5 countries

United States15 sites

  • Anaheim Clinical Trials Llc

    Anaheim, California, 92801

  • Brigham And Women'S Hospital

    Boston, Massachusetts, 02115

  • Alpine Clinical Research Center, Inc.

    Boulder, Colorado, 80304

  • The Ohio State University

    Columbus, Ohio, 43210

  • Michigan State University

    East Lansing, Michigan, 48824

  • Alexian Brothers Neurosciences Institute Clinical Research

    Elk Grove Village, Illinois, 60007

  • Associated Neurologists Of Southern Connecticut, P.C.

    Fairfield, Connecticut, 06824

  • The Clinical Trial Center, Llc

    Jenkintown, Pennsylvania, 19046

  • Study site

    Long Beach, California, 90806

  • Compass Research, Llc

    Orlando, Florida, 32806

  • Palm Beach Neurological Center Advanced Research Consultants

    Palm Beach Gardens, Florida, 33410

  • Hospital Of The University Of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Penn Memory Center

    Philadelphia, Pennsylvania, 19104

  • Lifetree Clinical Research

    Salt Lake City, Utah, 84106

  • Ucsf Memory And Aging Center

    San Francisco, California, 94158

Other trials in United States

Canada3 sites

  • Local Institution

    Greenfield Park, Quebec, J4V 2J2

  • Local Institution

    London, Ontario, N6C 5J1

  • Local Institution

    Toronto, Ontario, M3B 2S7

Other trials in Canada

France3 sites

  • Local Institution

    Lille, 59037

  • Local Institution

    Paris, 75013

  • Local Institution

    Toulouse, Cedex 9, 31059

Other trials in France

Germany2 sites

  • Local Institution

    Berlin, 14050

  • Local Institution

    Heidelberg, 69115

Other trials in Germany

Sweden1 site

  • Local Institution

    Stockholm, 141 86

Other trials in Sweden

About this study

Official title: 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

Being tested
BMS-241027, Placebo matching BMS-241027
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BMS-241027Drug

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

  • BMS-241027Drug

    Intravenous (IV), 0.01 mg/kg, Once Weekly, 9 weeks

  • BMS-241027Drug

    Intravenous (IV), 0.03 mg/kg, Once Weekly, 9 weeks

  • Placebo matching BMS-241027Drug

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

Study groups in NCT01492374
Study groupRoleWhat they receive
Arm 1: BMS-241027 (0.003 mg/kg)ExperimentalNot described
Receives: Drug: BMS-241027
Arm 2: BMS-241027 (0.01 mg/kg)ExperimentalNot described
Receives: Drug: BMS-241027
Arm 3: BMS-241027 (0.03 mg/kg)ExperimentalNot described
Receives: Drug: BMS-241027
Arm 4: Placebo matching BMS-241027ExperimentalNot described
Receives: Drug: Placebo matching BMS-241027

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Within the first 70 day after first dose

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

    Measured: Within the first 70 day after first dose

Secondary outcomes (9)

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

    Measured: Within the first 70 days after first dose

  2. Effects of BMS-241027 on cognitive performance using computerized cognitive tests

    Measured: Weeks 3, 6 and 9

  3. Effects of BMS-241027 on connectivity MRI

    Measured: Within the first 70 days after first dose

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

    Intensive pharmacokinetic parameter Cmax will be derived from subgroups of subjects at Week 7

    Measured: Weeks 1, 4, and 9

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

    Intensive pharmacokinetic parameter C24 will be derived from subgroups of subjects at Week 7

    Measured: Weeks 1, 4, and 9

  6. Time of maximal observed plasma concentration (Tmax) of BMS-241027 in subjects with mild Alzheimer's disease

    Intensive pharmacokinetic parameter Tmax will be derived from subgroups of subjects at Week 7

    Measured: Weeks 1, 4, and 9

  7. Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-241027 in subjects with mild Alzheimer's disease

    Intensive pharmacokinetic parameter AUC(TAU) will be derived from subgroups of subjects at Week 7

    Measured: Weeks 1, 4, and 9

  8. Safety assessments: based on vital sign measurements, ECGs and clinical laboratory tests

    Measured: Within the first 70 day after first dose

  9. Effects of BMS-241027 on CSF levels of neurofilaments

    Measured: Within the first 70 days after first dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2011 (estimated)
  2. Study startFeb 2012
  3. Primary completionOct 2013
  4. Study completionOct 2013

Resources

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01492374
Sponsor's protocol ID
CN167-003
Other IDs
2011-004065-33
Status last verified
Oct 2013
First submitted
13 Dec 2011
Last updated
24 Jul 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BMS-241027 in people with Alzheimer's Disease, run by Bristol-Myers Squibb at 24 sites in 5 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 6 inclusion and 11 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: finished, as of the sponsor's last update on 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States, Canada, France, Germany, Sweden. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 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). The study lists 2 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 NCT01492374.

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 24 Jul 2014.

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