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

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ClinicalTrials.gov Identifier: NCT02434718
Recruitment Status : Completed
First Posted : May 5, 2015
Last Update Posted : August 21, 2020
Sponsor:
Information provided by (Responsible Party):
Biogen

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : June 24, 2015
Actual Primary Completion Date : December 9, 2016
Actual Study Completion Date : December 9, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Aducanumab

Arms and Interventions
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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
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02434718


Locations
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Japan
Research Site
Toon, Ehime, Japan
Research Site
Kobe, Hyogo, Japan
Research Site
Kamakura, Kanagawa, Japan
Research Site
Kanzaki, Saga, Japan
Research Site
Kodaira, Tokoyo, Japan
Research Site
Shinjuku, Tokoyo, Japan
Research Site
Kyoto, Japan
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
More Information
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02434718    
Other Study ID Numbers: 221AD104
First Posted: May 5, 2015    Key Record Dates
Last Update Posted: August 21, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders