ENVISION Study (Closed)

This study is now closed.

What is the ENVISION study? 
ENVISION is a Phase 3b/4, Randomized, Double-Blind, Placebo-Controlled study for participants with Alzheimer’s (AD), including those with Mild Cognitive Impairment (MCI) due to Alzheimer’s disease or mild Alzheimer’s disease dementia. Approximately 1,512 participants will be enrolled in the study across 220 global study centers. Aducanumab or the placebo will be administered by IV once every four weeks over the two-and-a-half-year study. The study will include up to 24 months of treatment as well as screening and post-treatment follow up activities.
What is the purpose of the ENVISION study? 
The purpose of this Phase 3b/4 confirmatory study is to verify the clinical benefit of aducanumab and its effect on clinical decline compared with placebo in participants with AD, including those with MCI due to AD or mild AD dementia.

The ENVISION study follows the EMBARK, ENGAGE and PRIME studies (from the same researchers) which demonstrated that higher doses of aducanumab reduced beta-amyloid accumulation in multiple areas of the brain, and slowed decline in cognitive functioning as measured by two different cognitive assessment scales.
What is Aducanumab? 
Aducanumab is a monoclonal antibody targeting soluble and insoluble aggregated forms of amyloid beta. Aducanumab modifies the underlying pathophysiological disease course 
by removing amyloid plaques, which are considered one of the hallmarks of Alzheimer’s 
disease. In June 2021, aducanumab was approved by the US FDA under the accelerated approval pathway as a treatment for Alzheimer’s disease.
Eligibility

This study is for men and women aged 60-85 with a diagnosis of MCI due to AD or mild AD.


Interested individuals can learn more about their eligibility by contacting the Memory and Aging Program Outreach Team at 401-455-6402 or by sending an email to memory@butler.org.

Organization
Butler Hospital

Recruitment Status
Open