PROPEL

CompletedPhase 1

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

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

Lead sponsor

Biogen

Asset

Aducanumab

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•Study partner/caregiver required

Primary endpoints

•Incidence and nature of adverse events (AE) / serious adverse events(SAE)•Clinically significant changes in vital signs•Brain magnetic resonance imaging (MRI) findings to assess amyloid-related

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID221AD104

NCT IDNCT02434718

Timeline

Milestones

Study first posted2015-05-05estimated

Study start2015-06-24actual

Primary completion2016-12-09actual

Study completion2016-12-09actual

Last update posted2020-08-21actual

Assets

Drug assets

Aducanumab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion 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)

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

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Amyloid biomarkers

1 endpoint

Primary/protocol endpoint

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

event count, event

Safety / tolerability / PK

7 endpoints

Primary/protocol endpoint

Incidence and nature of adverse events (AE) / serious adverse events(SAE)

Time frame:Up to week 42

event count, event

Primary/protocol endpoint

Clinically significant changes in vital signs and 12-lead electrocardiogram (ECG) data; abnormalities in neurological and physical examinations

Time frame:Up to week 42

descriptive

Secondary/protocol endpoint

Area under the concentration-time curve (AUC) from time zero extrapolated to infinity (AUC0-∞)