臨床研究等提出・公開システム

A Phase 3b/4 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Verify the Clinical Benefit of Aducanumab (BIIB037) in Participants with Alzheimer's Disease

Phase 3b/4 Study of Aducanumab in Alzheimer's Disease

Toda Yasuo

Biogen Japan Ltd.

Nihonbashi 1-chome Mitsui Building 14F, 1-4-1, Nihonbashi, Chuo-ku, Tokyo, 103-0027

japan-medinfo@biogen.com

Biogen Japan Medical Information

Biogen Japan Ltd.

Nihonbashi 1-chome Mitsui Building 14F, 1-4-1, Nihonbashi, Chuo-ku, Tokyo, 103-0027

+81-120-560-086

japan-medinfo@biogen.com

Suspended

Jan. 31, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

-The participant must have confirmed amyloid beta pathology by CSF or amyloid PET.

-The participant must have a history of subjective memory decline with gradual onset and slow progression over the last 6 months before Screening, confirmed by study partner.

-The participant must meet all of the following clinical criteria for MCI due to Alzheimer's disease or mild Alzheimer's disease according to NIA-AA criteria
-Have an MMSE score between 22 and 30 inclusive
-Have a CDR memory score >= 0.5
-Have a CDR-GS of 0.5 or 1.0
-Have an RBANS score of 85 or lower indicative of objective cognitive impairment

-The participant must be in good health, apart from a clinical diagnosis of early Alzheimer's disease, as determined by the Investigator based on medical history and screening assessments.

-The participant must consent to ApoE genotyping.

-The participant must have 1 informant/care partner who, in the Investigator's opinion, has frequent and sufficient contact with the participant (at least 10 hours/week in person or by phone) as to be able to provide accurate information about the participant's cognitive and functional abilities over time.

-Any uncontrolled medical or neurological/neurodegenerative condition (other than Alzheimer's disease) that, in the opinion of the Investigator, might be a contributing cause of the participant's cognitive impairment.

-Clinically significant and/or unstable psychiatric illness within 6 months prior to Screening.

-Transient ischemic attack or stroke or any unexplained loss of consciousness within 1 year prior to Screening.

-History of severe allergic or anaphylactic reactions or of hypersensitivity to any of the inactive ingredients in the drug product.

-Participation in any study with purported disease-modifying effect in Alzheimer's disease within 12 months prior to Screening unless documentation of receipt of placebo is available.

-Current use or previous use of medications with a purported disease-modifying effect in Alzheimer's disease, outside of investigational studies.

-Use of any medications that, in the opinion of the Investigator, may contribute to cognitive impairment, put the participant at higher risk for AEs, or impair the participant's ability to perform cognitive testing or complete study procedures.

-Use of any investigational drug.

-Prior exposure to aducanumab either commercially or by participation in a previous study with aducanumab. (Participants are eligible if they did not receive active aducanumab.)

-A negative PET scan result with any amyloid-targeting ligand within 12 months prior to Screening.

Both

Alzheimer's Disease

Research Name : BIIB037
Generic Name : Aducanumab-avwa
Trade Names : Aduhelm
participants will receive either aducanumab 10 mg/kg or placebo IV every 4 weeks.

Change from baseline in CDR-SB score at Week 78.

-Change from baseline in amyloid PET signal at Week 78 and Week 104

-Change from baseline in tau PET signal at Week 78 and Week 104

-Change from baseline in CDR-SB score at Week 106

-Change from baseline in iADRS score at Week 78 and 106

-Change from baseline in ADCS-ADL-MCI score at Week 78 and 106

-Change from baseline in ADAS-Cog13 score at Week 78 and 106

-Change from baseline in MMSE score at Week 78 and 106

-Change from baseline in NPI-10 score at Week 78 and 106

-Change from baseline in GST composite z-score(based on CDR-SB, ADAS-Cog13 and ADCSADL-MCI) at Week 78 and Week 106

+81-24-934-5322

Sept. 18, 2022

France/Italy/Spain/Germany/Portugal/Belgium/Finland/Poland/Switzerland/Sweden/South Korea/Australia/Canada/Brazil/Mexico/United States/United Kingdom