Single and Multiple Ascending Dose Study of Aducanumab (BIIB037) in Japanese Participants With Alzheimer's Disease
NCT ID: NCT02434718
Last Updated: 2020-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
21 participants
INTERVENTIONAL
2015-06-24
2016-12-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Cohort 1
IV infusion in cohorts assigned to low dose 1; 1 participant per cohort will receive placebo
Aducanumab
As described in the treatment arm
Placebo
IV administration of 0.9% sodium chloride
Cohort 2
IV infusion in cohorts assigned to low dose 2; 1 participant per cohort will receive placebo
Aducanumab
As described in the treatment arm
Placebo
IV administration of 0.9% sodium chloride
Cohort 3
IV infusion in cohorts assigned to high dose; 1 participant per cohort will receive placebo
Aducanumab
As described in the treatment arm
Placebo
IV administration of 0.9% sodium chloride
Cohort 4
IV infusion in cohorts assigned to mid dose; 1 participant per cohort will receive placebo
Aducanumab
As described in the treatment arm
Placebo
IV administration of 0.9% sodium chloride
Interventions
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Aducanumab
As described in the treatment arm
Placebo
IV administration of 0.9% sodium chloride
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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
55 Years
85 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Research Site
Tōon, Ehime, Japan
Research Site
Kobe, Hyōgo, Japan
Research Site
Kamakura, Kanagawa, Japan
Research Site
Kanzaki, Saga-ken, Japan
Research Site
Kodaira, Tokoyo, Japan
Research Site
Shinjuku, Tokoyo, Japan
Research Site
Kyoto, , Japan
Countries
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Other Identifiers
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221AD104
Identifier Type: -
Identifier Source: org_study_id
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