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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02434718
Recruitment Status : Completed
First Posted : May 5, 2015
Last Update Posted : April 10, 2017
Sponsor:
Information provided by (Responsible Party):
Biogen

Tracking Information
First Submitted Date  ICMJE April 30, 2015
First Posted Date  ICMJE May 5, 2015
Last Update Posted Date April 10, 2017
Actual Study Start Date  ICMJE June 30, 2015
Actual Primary Completion Date December 9, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2015)
  • Incidence and nature of adverse events (AE) / serious adverse events(SAE) [ Time Frame: Up to week 42 ]
  • Clinically significant changes in vital signs and 12-lead electrocardiogram (ECG) data; abnormalities in neurological and physical examinations [ Time Frame: 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) [ Time Frame: Up to week 42 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 30, 2015)
  • Incidence and nature of adverse events (AE) / serious adverse events(SAE) [ Time Frame: Up to week 42 ]
  • Brain magnetic resonance imaging (MRI) findings to asses amyloid-related imaging abnormalities (ARIA), including incidence of ARIA-E (edema) or ARIA-H (hemosiderosis) [ Time Frame: Up to week 42 ]
  • Clinically significant changes in vital signs and 12-lead electrocardiogram (ECG) data; abnormalities in neurological and physical examinations [ Time Frame: Up to week 42 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2016)
  • Area under the concentration-time curve (AUC) from time zero extrapolated to infinity (AUC0-∞) [ Time Frame: Up to 8 weeks post dosing ]
  • AUC from time zero to time of the last measurable concentration (AUC0-last) [ Time Frame: Up to 8 weeks post dosing ]
  • Maximum observed concentration (Cmax) [ Time Frame: Up to 8 weeks post dosing ]
  • Time to Cmax (Tmax) [ Time Frame: Up to 8 weeks post dosing ]
  • Elimination half-life (t1/2) [ Time Frame: Up to 8 weeks post dosing ]
  • Volume of distribution at steady state (Vss) [ Time Frame: Up to 8 weeks post dosing ]
  • Clearance (CL) after a single IV infusion of aducanumab [ Time Frame: Up to 8 weeks post dosing ]
  • Incidence of anti-aducanumab antibodies in serum [ Time Frame: Up to week 42 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2015)
  • Area under the concentration-time curve (AUC) from time zero extrapolated to infinity (AUC0-∞) [ Time Frame: Up to 8 weeks post dosing ]
  • AUC from time zero to time of the last measurable concentration (AUC0-last) [ Time Frame: Up to 8 weeks post dosing ]
  • Maximum observed serum concentration (Cmax) of BIIB037 [ Time Frame: Up to 8 weeks post dosing ]
  • Time to Cmax (Tmax) [ Time Frame: Up to 8 weeks post dosing ]
  • Elimination half-life (t1/2) [ Time Frame: Up to 8 weeks post dosing ]
  • Volume of distribution at steady state (Vss) [ Time Frame: Up to 8 weeks post dosing ]
  • Clearance (CL) [ Time Frame: Up to 8 weeks post dosing ]
  • Incidence of anti-BIIB037 antibodies in serum [ Time Frame: Up to week 42 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single and Multiple Ascending Dose Study of Aducanumab (BIIB037) in Japanese Participants With Alzheimer's Disease
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: Aducanumab
    As described in the treatment arm
  • Drug: Placebo
    IV administration of 0.9% sodium chloride
Study Arms  ICMJE
  • Experimental: Cohort 1
    IV infusion in cohorts assigned to low dose 1; 1 participant per cohort will receive placebo
    Interventions:
    • Drug: Aducanumab
    • Drug: Placebo
  • Experimental: Cohort 2
    IV infusion in cohorts assigned to low dose 2; 1 participant per cohort will receive placebo
    Interventions:
    • Drug: Aducanumab
    • Drug: Placebo
  • Experimental: Cohort 3
    IV infusion in cohorts assigned to high dose; 1 participant per cohort will receive placebo
    Interventions:
    • Drug: Aducanumab
    • Drug: Placebo
  • Experimental: Cohort 4
    IV infusion in cohorts assigned to mid dose; 1 participant per cohort will receive placebo
    Interventions:
    • Drug: Aducanumab
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 7, 2016)
21
Original Estimated Enrollment  ICMJE
 (submitted: April 30, 2015)
25
Actual Study Completion Date  ICMJE December 9, 2016
Actual Primary Completion Date December 9, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02434718
Other Study ID Numbers  ICMJE 221AD104
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biogen
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP