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

JRCT ID: jRCT2021220027

Registered date:25/10/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Alzheimer's Disease
• Date of first enrollment: 22/12/2022
• Target sample size: 1512
• Countries of recruitment: France,Japan,Italy,Japan,Spain,Japan,Germany,Japan,Portugal,Japan,Belgium,Japan,Finland,Japan,Poland,Japan,Switzerland,Japan,Sweden,Japan,South Korea,Japan,Australia,Japan,Canada,Japan,Brazil,Japan,Mexico,Japan,United States,Japan,United Kingdom,Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Change from baseline in CDR-SB score at Week 78.

Secondary Outcome

-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

Key inclusion & exclusion criteria

• Age minimum: >= 60age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

-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.

Exclude criteria

-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.

Related Information

• Primary Sponsor: Toda Yasuo
• Secondary ID(s): NCT05310071