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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
Aducanumab
Placebo
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Arm Description

IV infusion in cohorts assigned to low dose 1; 1 participant per cohort will receive placebo

IV infusion in cohorts assigned to low dose 2; 1 participant per cohort will receive placebo

IV infusion in cohorts assigned to high dose; 1 participant per cohort will receive placebo

IV infusion in cohorts assigned to mid dose; 1 participant per cohort will receive placebo

Outcomes

Primary Outcome Measures

Incidence and nature of adverse events (AE) / serious adverse events(SAE)
Clinically significant changes in vital signs and 12-lead electrocardiogram (ECG) data; abnormalities in neurological and physical examinations
Brain magnetic resonance imaging (MRI) findings to assess amyloid-related imaging abnormalities (ARIA), including incidence of ARIA-E (edema) or ARIA-H (hemosiderosis)

Secondary Outcome Measures

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

Full Information

First Posted
April 30, 2015
Last Updated
August 20, 2020
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT02434718
Brief Title
Single and Multiple Ascending Dose Study of Aducanumab (BIIB037) in Japanese Participants With Alzheimer's Disease
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
June 24, 2015 (Actual)
Primary Completion Date
December 9, 2016 (Actual)
Study Completion Date
December 9, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
IV infusion in cohorts assigned to low dose 1; 1 participant per cohort will receive placebo
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
IV infusion in cohorts assigned to low dose 2; 1 participant per cohort will receive placebo
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
IV infusion in cohorts assigned to high dose; 1 participant per cohort will receive placebo
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
IV infusion in cohorts assigned to mid dose; 1 participant per cohort will receive placebo
Intervention Type
Drug
Intervention Name(s)
Aducanumab
Intervention Description
As described in the treatment arm
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
IV administration of 0.9% sodium chloride
Primary Outcome Measure Information:
Title
Incidence and nature of adverse events (AE) / serious adverse events(SAE)
Time Frame
Up to week 42
Title
Clinically significant changes in vital signs and 12-lead electrocardiogram (ECG) data; abnormalities in neurological and physical examinations
Time Frame
Up to week 42
Title
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 Outcome Measure Information:
Title
Area under the concentration-time curve (AUC) from time zero extrapolated to infinity (AUC0-∞)
Time Frame
Up to 8 weeks post dosing
Title
AUC from time zero to time of the last measurable concentration (AUC0-last)
Time Frame
Up to 8 weeks post dosing
Title
Maximum observed concentration (Cmax)
Time Frame
Up to 8 weeks post dosing
Title
Time to Cmax (Tmax)
Time Frame
Up to 8 weeks post dosing
Title
Elimination half-life (t1/2)
Time Frame
Up to 8 weeks post dosing
Title
Volume of distribution at steady state (Vss)
Time Frame
Up to 8 weeks post dosing
Title
Clearance (CL) after a single IV infusion of aducanumab
Time Frame
Up to 8 weeks post dosing
Title
Incidence of anti-aducanumab antibodies in serum
Time Frame
Up to week 42

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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). 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Toon
State/Province
Ehime
Country
Japan
Facility Name
Research Site
City
Kobe
State/Province
Hyogo
Country
Japan
Facility Name
Research Site
City
Kamakura
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Kanzaki
State/Province
Saga
Country
Japan
Facility Name
Research Site
City
Kodaira
State/Province
Tokoyo
Country
Japan
Facility Name
Research Site
City
Shinjuku
State/Province
Tokoyo
Country
Japan
Facility Name
Research Site
City
Kyoto
Country
Japan

12. IPD Sharing Statement

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

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