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

Alzheimer's Disease Clinical Trial

— PROPEL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02434718
• Other study ID #: 221AD104
• Status: Completed
• Phase: Phase 1
• Start date: June 24, 2015
• Est. completion date: December 9, 2016

Study information

• Verified date: August 2020
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 9, 2016
• Est. primary completion date: December 9, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Aducanumab
As described in the treatment arm
• Placebo
IV administration of 0.9% sodium chloride

Locations

Country	Name	City	State
Japan	Research Site	Kamakura	Kanagawa
Japan	Research Site	Kanzaki	Saga
Japan	Research Site	Kobe	Hyogo
Japan	Research Site	Kodaira	Tokoyo
Japan	Research Site	Kyoto
Japan	Research Site	Shinjuku	Tokoyo
Japan	Research Site	Toon	Ehime

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and nature of adverse events (AE) / serious adverse events(SAE)		Up to week 42
Primary	Clinically significant changes in vital signs and 12-lead electrocardiogram (ECG) data; abnormalities in neurological and physical examinations		Up to week 42
Primary	Brain magnetic resonance imaging (MRI) findings to assess amyloid-related imaging abnormalities (ARIA), including incidence of ARIA-E (edema) or ARIA-H (hemosiderosis)		Up to week 42
Secondary	Area under the concentration-time curve (AUC) from time zero extrapolated to infinity (AUC0-8)		Up to 8 weeks post dosing
Secondary	AUC from time zero to time of the last measurable concentration (AUC0-last)		Up to 8 weeks post dosing
Secondary	Maximum observed concentration (Cmax)		Up to 8 weeks post dosing
Secondary	Time to Cmax (Tmax)		Up to 8 weeks post dosing
Secondary	Elimination half-life (t1/2)		Up to 8 weeks post dosing
Secondary	Volume of distribution at steady state (Vss)		Up to 8 weeks post dosing
Secondary	Clearance (CL) after a single IV infusion of aducanumab		Up to 8 weeks post dosing
Secondary	Incidence of anti-aducanumab antibodies in serum		Up to week 42