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ENVISION

A study to verify the clinical benefit of Aducanumab in participants with early Alzheimer's disease

Sponsor
Biogen
Clinical Trial
Drug
Aducanumab

Information about the drug that will be tested in the study

Administration

The drug will be administered via an intravenous infusion (an injection into the vein), monthly (once every four weeks).

Is the drug already on the market for another medical condition?

No

Will all participants receive the same drug?

Participants will be selected by chance to receive one of the following options:

  • An intravenous injection of Aducanumab (up to 10 milligrams per kilograms (mg/kg))
  • An intravenous injection of placebo (also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested with no active therapeutic effect).

Neither the participant nor his/her doctor will know if the person is receiving the investigational drug or the placebo.

Information about participating in the trial

What are the researchers trying to find out?

The purpose of the study is to verify the Clinical Benefit of monthly doses of Aducanumab in slowing cognitive and functional impairment in people with early Alzheimer's disease.

How long will the treatment last?

2 years

What your involvement will entail?

During the study, participants will be asked:

  • To complete a test that will assess memory, orientation, judgment and problem solving, personal care and community affairs (this is a test called CDR-SB)
  • To complete other tests that will assess their cognition, daily function, memory, and behaviour (i.e. tests like iADRS, ADCS-ADL-MCI, ADAS-Cog, MMSE, NPI-10)
  • Participants will have to undergo brain scan (PET).

Further information on the procedures, tests and number of visits can be obtained from the study team.

Who can participate in this study?

Who can participate in the study?
  • Be between 60 and 85 years old
  • Have a history of subjective memory decline with gradual onset and slow progression over the 6 months before screening, confirmed by study partner
  • Have a study partner who has a sufficient contact with the participant (at least 10 hours/week in person or by phone), provides the necessary information about the participant’s memory, behaviour and functioning
  • Have a score between 22-30 points in the MMSE test (a test about a range of everyday mental skills), a score of 0.5 or 1 on the Clinical Dementia Rating-Global Score (CDR-GS) and a score of 85 or lower in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). This would suggest that the person has an mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease according to National Institute on Aging and Alzheimer's Association (NIA-AA) criteria
  • Consent to apolipoprotein E (ApoE) genotyping
  • Have confirmed amyloid beta pathology by cerebrospinal fluid (CSF) or amyloid PET
  • Be in good health as determined by the Investigator based on medical history and screening assessments (apart from a clinical diagnosis of early Alzheimer's disease).
Who cannot participate in the study?

People cannot take part in the study if they have or have experienced (main exclusion criteria):

  • Any evidence of a condition other than Alzheimer’s disease that may affect cognition (e.g. other type of dementia, other neurodegenerative disease or infections with neurological involvement)
  • A disease or medical condition that may interfere with the study assessments and will make the participant unsuitable for participation in or completion of the trial procedures (i.e. delirium, psychosis, psychiatric disorder, stroke)
  • 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
  • Current use or previous use of medications with a purported disease-modifying effect in Alzheimer's disease, outside of investigational studies
  • Prior exposure to aducanumab either commercially or by participation in a previous study with aducanumab.

Information for your doctor

EudraCT Number

2022-001671-14

Clinicaltrials.gov identifier

NCT05310071

Study contact information

clinicaltrials@biogen.com

+41 21 345 9121

Link to full text

https://classic.clinicaltrials.gov/ct2/show/NCT05310071

The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) in April 2024.

The pharmaceutical company running this trial has reviewed this document.

Click here to download the accessible easy-to-read version of this document

Attachments
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Acknowledgement

Alzheimer Europe's Clinical Trials Watch database was developed as part of the 2018 Work Plan which received funding under an operating grant from the European Union’s Health Programme (2014–2020).

Alzheimer Europe gratefully acknowledges the support of its corporate sponsors for the update and maintenance of the database.

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