Trial record 2 of 5 for:    BIIB037

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2015 by Biogen
Information provided by (Responsible Party):
Biogen Identifier:
First received: April 30, 2015
Last updated: July 2, 2015
Last verified: June 2015

The primary objective of the study is to evaluate the safety and tolerability of single and multiple intravenous (IV) infusions of BIIB037 in Japanese participants with mild to moderate Alzheimer's Disease (AD). The secondary objectives of this study are as follows: To evaluate the serum pharmacokinetics (PK) of BIIB037 after single and multiple intravenous (IV) infusions of BIIB037; To evaluate the effect of single and multiple IV infusions of BIIB037 on immunogenicity.

Condition Intervention Phase
Alzheimer's Disease
Drug: BIIB037 (aducanumab)
Drug: Placebo
Phase 1

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

Resource links provided by NLM:

Further study details as provided by Biogen:

Primary Outcome Measures:
  • Incidence and nature of adverse events (AE) / serious adverse events(SAE) [ Time Frame: Up to week 42 ] [ Designated as safety issue: Yes ]
  • Brain magnetic resonance imaging (MRI) findings to assess amyloid-related imaging abnormalities (ARIA), including incidence of ARIA-E (edema) or ARIA-H (hemosiderosis) [ Time Frame: Up to week 42 ] [ Designated as safety issue: No ]
  • Clinically significant changes in vital signs and 12-lead electrocardiogram (ECG) data; abnormalities in neurological and physical examinations [ Time Frame: Up to week 42 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Area under the concentration-time curve (AUC) from time zero extrapolated to infinity (AUC0-∞) [ Time Frame: Up to 8 weeks post dosing ] [ Designated as safety issue: No ]
  • AUC from time zero to time of the last measurable concentration (AUC0-last) [ Time Frame: Up to 8 weeks post dosing ] [ Designated as safety issue: No ]
  • Maximum observed serum concentration (Cmax) of BIIB037 [ Time Frame: Up to 8 weeks post dosing ] [ Designated as safety issue: No ]
  • Time to Cmax (Tmax) [ Time Frame: Up to 8 weeks post dosing ] [ Designated as safety issue: No ]
  • Elimination half-life (t1/2) [ Time Frame: Up to 8 weeks post dosing ] [ Designated as safety issue: No ]
  • Volume of distribution at steady state (Vss) [ Time Frame: Up to 8 weeks post dosing ] [ Designated as safety issue: No ]
  • Clearance (CL) [ Time Frame: Up to 8 weeks post dosing ] [ Designated as safety issue: No ]
  • Incidence of anti-BIIB037 antibodies in serum [ Time Frame: Up to week 42 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: May 2015
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIIB037

IV infusion in cohorts assigned to doses up to 6 mg/kg

1 participant per cohort will receive placebo

Drug: BIIB037 (aducanumab)
As described in the treatment arm
Drug: Placebo
IV administration of 0.9% sodium chloride


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

Key Inclusion Criteria:

  • Must be ambulatory
  • Must have a clinical diagnosis of mild to moderate AD
  • Must be in good health as determined by the Investigator, based on medical history and Screening assessments
  • Must have a caregiver who, understands the study and assents to accompany the subject to all study site visits, provide information to the Investigator/study site staff, specifically about cognitive abilities and AEs/SAEs and return for per-protocol follow-up visits and procedures
  • Must consent to blood sample collection for deoxyribonucleic acid (DNA; genotyping) and ribonucleic acid (RNA; for potential future analysis).

Key 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
  • Transient ischemic attack or stroke or any unexplained loss of consciousness within 1 year prior to Screening
  • Poorly controlled diabetes mellitus, as defined by having dosage adjustment of diabetic medication within the 3 months prior to Day 1
  • History of unstable angina, myocardial infarction, chronic heart failure
  • Chronic, uncontrolled hypertension
  • History of seizure within 3 years prior to Screening
  • History within the past 6 months or evidence of clinically significant psychiatric illness
  • History of severe allergic or anaphylactic reactions, or history of hypersensitivity to any of the inactive ingredients in the drug product

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02434718

Contact: Biogen

Research Site Recruiting
Kamakura, Kanagawa, Japan
Research Site Recruiting
Shinjuku, Tokoyo, Japan
Sponsors and Collaborators
Study Director: Medical Director Biogen
  More Information

No publications provided

Responsible Party: Biogen Identifier: NCT02434718     History of Changes
Other Study ID Numbers: 221AD104
Study First Received: April 30, 2015
Last Updated: July 2, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency (PMDA)

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies processed this record on October 09, 2015