Overview

This trial is active, not recruiting.

Condition alzheimer's disease
Treatments aducanumab, placebo
Phase phase 1
Sponsor Biogen
Start date June 2015
End date December 2016
Trial size 21 participants
Trial identifier NCT02434718, 221AD104

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
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
(Experimental)
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
(Experimental)
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
(Experimental)
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

Primary Outcomes

Measure
Incidence and nature of adverse events (AE) / serious adverse events(SAE)
time frame: Up to week 42
Clinically significant changes in vital signs and 12-lead electrocardiogram (ECG) data; abnormalities in neurological and physical examinations
time frame: Up to week 42
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

Secondary Outcomes

Measure
Area under the concentration-time curve (AUC) from time zero extrapolated to infinity (AUC0-∞)
time frame: Up to 8 weeks post dosing
AUC from time zero to time of the last measurable concentration (AUC0-last)
time frame: Up to 8 weeks post dosing
Maximum observed concentration (Cmax)
time frame: Up to 8 weeks post dosing
Time to Cmax (Tmax)
time frame: Up to 8 weeks post dosing
Elimination half-life (t1/2)
time frame: Up to 8 weeks post dosing
Volume of distribution at steady state (Vss)
time frame: Up to 8 weeks post dosing
Clearance (CL) after a single IV infusion of aducanumab
time frame: Up to 8 weeks post dosing
Incidence of anti-aducanumab antibodies in serum
time frame: Up to week 42

Eligibility Criteria

Male or female participants from 55 years up to 85 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Biogen.