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Single Ascending Dose Study of BIIB037 in Subjects With Alzheimer's Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01397539
First received: June 30, 2011
Last updated: September 20, 2012
Last verified: September 2012
History of Changes
  Purpose

The purpose of the study is to evaluate the safety and tolerability of a range of BIIB037 doses administered as single intravenous (IV) infusions in subjects with AD.


Condition Intervention Phase
Alzheimer's Disease
 Drug: BIIB037
Other: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Blinded, Placebo-Controlled Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB037 in Subjects With Mild to Moderate Alzheimer's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • Safety as measured by adverse event monitoring, laboratory assessments and MRI Tolerability as measured by adverse event monitoring, laboratory assessments and MRI [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • evaluate the PK of BIIB037 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • evaluate the immunogenicity of BIIB037 after single dose administration [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 48
Study Start Date: June 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIIB037 Drug: BIIB037
Subjects will receive a single dose of BIIB037 IV
Placebo Comparator: Placebo Other: Placebo
IV

Detailed Description:

BIIB037 is an investigational product being developed as a treatment for Alzheimer's disease (AD). BIIB037 is a fully human immunoglobulin gamma 1 (IgG1) monoclonal antibody that is selective for the fibrillar of Aß. In animal models of Alzheimer's disease, treatment with BIIB037 was shown to decrease beta amyloid content in animal brain. The study will be conducted in subjects with mild to moderate AD to profile the safety, tolerability, and pharmacokinetics (PK) of single doses of BIIB037 in the presence of the biological target (i.e., Aß plaques).

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women aged 55 to 85 years old, inclusive, at the time of informed consent
  • Must be ambulatory

  • Must have a clinical diagnosis of AD consistent with the following:

    1. Probable AD, according to National Institute of Neurological and Communicative Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria [McKhann et al. 1984].
    2. Dementia of Alzheimer's type, according to Diagnostic and Statistical Manual of Mental Disorders-Text Revision (DSM IV TR) criteria [American Psychiatric Association 2000]
  • Subject (or subject's permanent caregiver) has the ability to understand the purpose and risks of the study and provide signed and dated informed consent (or assent) and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
  • Must have a Mini Mental State Examination (MMSE) score of 14 to 26 inclusive.

Exclusion Criteria:

  • Any medical or neurological condition (other than AD) that in the opinion of the Investigator could be a contributing cause of the subject's dementia (e.g., medication use, vitamin B12 deficiency, abnormal thyroid function, stroke or other cerebrovascular condition, diffuse Lewy body disease, head trauma).
  • History within the past 6 months or evidence of clinically significant psychiatric illness (e.g., major depression, schizophrenia, or bipolar affective disorder).
  • Subject currently lives in a nursing home.
  • Blood donation (1 unit or more) within the 1 month prior to Screening
  • Participation in any other drug, biologic, device, or clinical study or treatment with any investigational drug or approved therapy for investigational use within 30 days (or 5 half lives, whichever is longer) prior to Screening, and/or participation in any other clinical study involving experimental medications for AD within the 60 days (or 5 half lives, whichever is longer) prior to Screening.
  • Any contraindications to having a brain MRI (e.g., pacemaker; non MRI-compatible aneurysm clips, artificial heart valves, or other metal foreign body; claustrophobia).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01397539

Locations
United States, California
Glendale Adventist Medical Center
Glendale, California, United States
United States, Florida
MD Clinical
Hallandale Beach, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec Medical Director, Biogen Idec Inc
ClinicalTrials.gov Identifier: NCT01397539     History of Changes
Other Study ID Numbers: 221AD101
Study First Received: June 30, 2011
Last Updated: September 20, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013