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

Sponsor

Biogen (Industry)

Overall Status

Completed

CT.gov ID

NCT02434718

Collaborator

(none)

Enrollment

Locations

Arms

17.5

Actual Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease	Drug: Aducanumab Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, 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 Aducanumab (BIIB037) in Japanese Subjects With Mild to Moderate Alzheimer's Disease

Actual Study Start Date :

Jun 24, 2015

Actual Primary Completion Date :

Dec 9, 2016

Actual Study Completion Date :

Dec 9, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 IV infusion in cohorts assigned to low dose 1; 1 participant per cohort will receive placebo	Drug: Aducanumab As described in the treatment arm Drug: Placebo IV administration of 0.9% sodium chloride
Experimental: Cohort 2 IV infusion in cohorts assigned to low dose 2; 1 participant per cohort will receive placebo	Drug: Aducanumab As described in the treatment arm Drug: Placebo IV administration of 0.9% sodium chloride
Experimental: Cohort 3 IV infusion in cohorts assigned to high dose; 1 participant per cohort will receive placebo	Drug: Aducanumab As described in the treatment arm Drug: Placebo IV administration of 0.9% sodium chloride
Experimental: Cohort 4 IV infusion in cohorts assigned to mid dose; 1 participant per cohort will receive placebo	Drug: Aducanumab As described in the treatment arm Drug: Placebo IV administration of 0.9% sodium chloride

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country
1	Research Site	Toon	Ehime	Japan
2	Research Site	Kobe	Hyogo	Japan
3	Research Site	Kamakura	Kanagawa	Japan
4	Research Site	Kanzaki	Saga	Japan
5	Research Site	Kodaira	Tokoyo	Japan
6	Research Site	Shinjuku	Tokoyo	Japan
7	Research Site	Kyoto		Japan

Sponsors and Collaborators

Biogen

Investigators

Study Director: Medical Director, Biogen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Biogen

ClinicalTrials.gov Identifier:

NCT02434718

Other Study ID Numbers:

221AD104

First Posted:

May 5, 2015

Last Update Posted:

Aug 21, 2020

Last Verified:

Aug 1, 2020

Additional relevant MeSH terms:

Alzheimer Disease

Study Results

No Results Posted as of Aug 21, 2020