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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05310071




Registration number
NCT05310071
Ethics application status
Date submitted
25/03/2022
Date registered
4/04/2022

Titles & IDs
Public title
A Study to Verify the Clinical Benefit of Aducanumab in Participants With Early Alzheimer's Disease
Scientific title
A Phase 3b/4 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Verify the Clinical Benefit of Aducanumab (BIIB037) in Participants With Alzheimer's Disease
Secondary ID [1] 0 0
2022-001671-14
Secondary ID [2] 0 0
221AD305
Universal Trial Number (UTN)
Trial acronym
ENVISION
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Aducanumab
Treatment: Drugs - Placebo

Experimental: Aducanumab - Participants will receive aducanumab, up to 10 milligrams per kilograms (mg/kg), monthly (once every four weeks), administered as intravenous (IV) infusion.

Placebo comparator: Placebo - Participants will receive placebo, monthly (once every four weeks), administered as IV infusion.


Treatment: Drugs: Aducanumab
Administered as specified in the treatment arm.

Treatment: Drugs: Placebo
Administered as specified in the treatment arm.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline in CDR-SB Score at Week 78
Timepoint [1] 0 0
Baseline, Week 78
Secondary outcome [1] 0 0
Change From Baseline in Integrated Alzheimer's Disease Rating Scale (iADRS) Score at Weeks 78 and 106
Timepoint [1] 0 0
Baseline, Weeks 78 and 106
Secondary outcome [2] 0 0
Change From Baseline in ADCS-ADL-MCI Score at Weeks 78 and 106
Timepoint [2] 0 0
Baseline, Weeks 78 and 106
Secondary outcome [3] 0 0
Change From Baseline in ADAS-Cog13 Score at Weeks 78 and 106
Timepoint [3] 0 0
Baseline, Weeks 78 and 106
Secondary outcome [4] 0 0
Change From Baseline in Mini-Mental State Examination (MMSE) Score at Weeks 78 and 106
Timepoint [4] 0 0
Baseline, Weeks 78 and 106
Secondary outcome [5] 0 0
Change From Baseline in Neuropsychiatric Inventory-10 (NPI-10) Score at Weeks 78 and 106
Timepoint [5] 0 0
Baseline, Weeks 78 and 106
Secondary outcome [6] 0 0
Change From Baseline in Amyloid Positron Emission Tomography (PET) Signal at Weeks 78 and 104
Timepoint [6] 0 0
Baseline, Weeks 78 and 104
Secondary outcome [7] 0 0
Change From Baseline in Tau PET Signal at Weeks 78 and 104
Timepoint [7] 0 0
Baseline, Weeks 78 and 104
Secondary outcome [8] 0 0
Change From Baseline in CDR-SB Score at Week 106
Timepoint [8] 0 0
Baseline, Week 106
Secondary outcome [9] 0 0
Change From Baseline in Global Statistical Test (GST) Composite Z-Score
Timepoint [9] 0 0
Baseline, Weeks 78 and 106

Eligibility
Key inclusion criteria
Key

* The participant must have confirmed amyloid beta pathology by cerebrospinal fluid (CSF) or amyloid PET
* Must have history of subjective memory decline with gradual onset and slow progression over the 6 months before Screening, confirmed by study partner
* 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
* Must meet all of the following clinical criteria for MCI due to Alzheimer's disease or mild Alzheimer's disease according to National Institute on Aging and Alzheimer's Association (NIA-AA) criteria

1. Have an MMSE score between 22 and 30 inclusive
2. Have a CDR memory score >0.5
3. Have a Clinical Dementia Rating Scale Global Score (CDR-GS) of 0.5 or 1.0
4. Have a Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score of 85 or lower indicative of objective cognitive impairment
* Apart from a clinical diagnosis of early Alzheimer's disease, the participant must be in good health as determined by the Investigator based on medical history and screening assessments
* Must consent to apolipoprotein E (ApoE) genotyping. (Note: Participants are not required to be ApoE e4 carriers)

Key
Minimum age
60 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion 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

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
12/08/2024
Sample size
Target
Accrual to date
Final
1027
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [2] 0 0
KaRa Institute of Neurological Diseases - Macquarie Park
Recruitment hospital [3] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [4] 0 0
Frankston Hospital - Frankston
Recruitment hospital [5] 0 0
Austin Health - Heidelberg
Recruitment hospital [6] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [7] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [8] 0 0
Australian Alzheimer's Research Foundation - Nedlands
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2113 - Macquarie Park
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 0 0
3199 - Frankston
Recruitment postcode(s) [5] 0 0
3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment outside Australia
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Scania
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Bristol

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biogen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Biogen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05310071