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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01397539
Recruitment Status : Completed
First Posted : July 19, 2011
Last Update Posted : March 23, 2015
Information provided by (Responsible Party):

Brief Summary:
The primary objective of the study is to evaluate the safety and tolerability of a range of BIIB037 doses administered as single intravenous (IV) infusions in participants with mild to moderate Alzheimer's Disease (AD). Secondary objectives of this study in this study population are to assess the pharmacokinetics(PK) and to evaluate the immunogenicity of BIIB037 after single-dose administration.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: BIIB037 Other: Placebo Phase 1

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 form of beta amyloid (Aß).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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
Study Start Date : June 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Aducanumab

Arm Intervention/treatment
Experimental: BIIB037
A single dose of BIIB037 by intravenous infusion.
Drug: BIIB037
Participants receive a single dose of BIIB037 by intravenous (IV) infusion in cohorts assigned to the following ascending doses: .03 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg, 30 mg/kg, and 60 mg/kg.
Other Names:
  • Aducanumab
  • fully human IgG1 anti-Aβ mAb

Placebo Comparator: Placebo
A single dose of placebo matching BIIB037 by intravenous infusion.
Other: Placebo
Participants receive a single dose of matching BIIB037 placebo by intravenous (IV) infusion.

Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 6 months ]
    Incidence and nature of adverse events (AEs) and serious adverse events (SAEs). Significant assessments reported as AEs or SAEs include clinical laboratory assessments and vital signs, physical and neurological examination, 12-lead electrocardiogram (ECG), and brain MRI findings (including the occurrence of vasogenic edema and incident hemorrhage).

Secondary Outcome Measures :
  1. Area Under the Curve from Time Zero Extrapolated to Infinity [AUC0-∞] [ Time Frame: 6 months ]
  2. Area Under the Curve from Time 0 to Time of the Last Measurable Concentration [AUC0-tlast] [ Time Frame: 6 months ]
  3. Maximum Concentration [Cmax] of BIIB037 [ Time Frame: 6 Months ]
  4. Time to Cmax [Tmax] [ Time Frame: 6 Months ]
  5. Elimination Half-life [t1/2] [ Time Frame: 6 Months ]
  6. Clearance [Cl] [ Time Frame: 6 Months ]
  7. Incidence of Anti-BIIB037 Antibodies in Serum [ Time Frame: 6 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  • Must be ambulatory
  • Must have a clinical diagnosis of Alzheimer's Disease (AD) consistent with the following:

    1. Probable Alzheimer's Disease (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.

Key Exclusion Criteria:

  • Any medical or neurological condition other than Alzheimer's Disease (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 Magnetic Resonance Imaging (MRI) e.g., pacemaker; Non-Magnetic Resonance Imaging (MRI)-compatible aneurysm clips, artificial heart valves, or other metal foreign body; claustrophobia).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01397539

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United States, Florida
Brain Matters Research
Delray Beach, Florida, United States, 33445
Compass Research, LLC
Orlando, Florida, United States, 32806
United States, Ohio
Insight Clinical Trials, LLC
Beachwood, Ohio, United States, 44122
Sponsors and Collaborators
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Study Director: Medical Director Biogen
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Biogen Identifier: NCT01397539    
Other Study ID Numbers: 221AD101
First Posted: July 19, 2011    Key Record Dates
Last Update Posted: March 23, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders