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Completed

NCT Number: NCT02434718

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

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Tōon, Ehime, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aducanumab

Drug

As described in the treatment arm

Placebo

Drug

IV administration of 0.9% sodium chloride

Primary outcomes

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

    Time frame: Up to week 42

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

    Time frame: Up to week 42

  3. 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

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

    Time frame: Up to 8 weeks post dosing

  2. AUC from time zero to time of the last measurable concentration (AUC0-last)

    Time frame: Up to 8 weeks post dosing

  3. Maximum observed concentration (Cmax)

    Time frame: Up to 8 weeks post dosing

  4. Time to Cmax (Tmax)

    Time frame: Up to 8 weeks post dosing

  5. Elimination half-life (t1/2)

    Time frame: Up to 8 weeks post dosing

  6. Volume of distribution at steady state (Vss)

    Time frame: Up to 8 weeks post dosing

  7. Clearance (CL) after a single IV infusion of aducanumab

    Time frame: Up to 8 weeks post dosing

  8. Incidence of anti-aducanumab antibodies in serum

    Time frame: Up to week 42

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study 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

Acronym: PROPEL

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 5, 2015
Registry last updated
Aug 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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