Clinical trial NCT02434718: Single and Multiple Ascending Dose Study of Aducanumab (BIIB037) in Japanese Participants With Alzheimer's Disease
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Aducanumab (BIIB037) in Japanese Subjects With Mild to Moderate Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2015-05-05
Enrollment: 21
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to evaluate the safety and tolerability of single and multiple intravenous (IV) infusions of Aducanumab 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 Aducanumab after single and multiple intravenous (IV) infusions of Aducanumab; To evaluate the effect of single and multiple IV infusions of Aducanumab on immunogenicity.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence and nature of adverse events (AE) / serious adverse events(SAE)
timeFrame: Up to week 42
measure: Clinically significant changes in vital signs and 12-lead electrocardiogram (ECG) data; abnormalities in neurological and physical examinations
timeFrame: Up to week 42
measure: Brain magnetic resonance imaging (MRI) findings to assess amyloid-related imaging abnormalities (ARIA), including incidence of ARIA-E (edema) or ARIA-H (hemosiderosis)
timeFrame: Up to week 42
Secondary outcomes:
measure: Area under the concentration-time curve (AUC) from time zero extrapolated to infinity (AUC0-∞)
timeFrame: Up to 8 weeks post dosing
measure: AUC from time zero to time of the last measurable concentration (AUC0-last)
timeFrame: Up to 8 weeks post dosing
measure: Maximum observed concentration (Cmax)
timeFrame: Up to 8 weeks post dosing
measure: Time to Cmax (Tmax)
timeFrame: Up to 8 weeks post dosing
measure: Elimination half-life (t1/2)
timeFrame: Up to 8 weeks post dosing
measure: Volume of distribution at steady state (Vss)
timeFrame: Up to 8 weeks post dosing
measure: Clearance (CL) after a single IV infusion of aducanumab
timeFrame: Up to 8 weeks post dosing
measure: Incidence of anti-aducanumab antibodies in serum
timeFrame: Up to week 42
Other outcomes:
Locations:
city: Toon
country: Japan
facility: Research Site
state: Ehime
city: Kobe
country: Japan
facility: Research Site
state: Hyogo
city: Kamakura
country: Japan
facility: Research Site
state: Kanagawa
city: Kanzaki
country: Japan
facility: Research Site
state: Saga
city: Kodaira
country: Japan
facility: Research Site
state: Tokoyo
city: Shinjuku
country: Japan
facility: Research Site
state: Tokoyo
city: Kyoto
country: Japan
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: