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Trial record 2 of 7 for:    BIIB037

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):

Tracking Information
First Submitted Date  ICMJE June 30, 2011
First Posted Date  ICMJE July 19, 2011
Last Update Posted Date March 23, 2015
Study Start Date  ICMJE June 2011
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2014)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: July 18, 2011)
  • nature of adverse events (AEs) [ Time Frame: 6 months ]
  • serious adverse events (SAEs) [ Time Frame: 6 months ]
  • clinical laboratory assessments [ Time Frame: 6 months ]
  • vital signs [ Time Frame: 6 months ]
  • brain magnetic resonance imaging (MRI) findings (including the occurrence of vasogenic edema and incident hemorrhage). [ Time Frame: 6 months ]
  • neurological examination [ Time Frame: 6 months ]
Change History Complete list of historical versions of study NCT01397539 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2014)
  • Area Under the Curve from Time Zero Extrapolated to Infinity [AUC0-∞] [ Time Frame: 6 months ]
  • Area Under the Curve from Time 0 to Time of the Last Measurable Concentration [AUC0-tlast] [ Time Frame: 6 months ]
  • Maximum Concentration [Cmax] of BIIB037 [ Time Frame: 6 Months ]
  • Time to Cmax [Tmax] [ Time Frame: 6 Months ]
  • Elimination Half-life [t1/2] [ Time Frame: 6 Months ]
  • Clearance [Cl] [ Time Frame: 6 Months ]
  • Incidence of Anti-BIIB037 Antibodies in Serum [ Time Frame: 6 Months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2011)
serum BIIB037 concentrations and PK parameters (including AUC0-∞, AUC0 tlast, maximum concentration [Cmax], time to Cmax [Tmax], elimination half-life [t1/2], and Cl); and incidence of anti-BIIB037 antibodies in serum. [ Time Frame: 6 Months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Single Ascending Dose Study of BIIB037 in Participants With Alzheimer's Disease
Official Title  ICMJE 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
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.
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • 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
  • Other: Placebo
    Participants receive a single dose of matching BIIB037 placebo by intravenous (IV) infusion.
Study Arms  ICMJE
  • Experimental: BIIB037
    A single dose of BIIB037 by intravenous infusion.
    Intervention: Drug: BIIB037
  • Placebo Comparator: Placebo
    A single dose of placebo matching BIIB037 by intravenous infusion.
    Intervention: Other: Placebo
Publications * Ferrero J, Williams L, Stella H, Leitermann K, Mikulskis A, O'Gorman J, Sevigny J. First-in-human, double-blind, placebo-controlled, single-dose escalation study of aducanumab (BIIB037) in mild-to-moderate Alzheimer's disease. Alzheimers Dement (N Y). 2016 Jun 20;2(3):169-176. doi: 10.1016/j.trci.2016.06.002. eCollection 2016 Sep.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 12, 2014)
Original Estimated Enrollment  ICMJE
 (submitted: July 18, 2011)
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01397539
Other Study ID Numbers  ICMJE 221AD101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biogen
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP