TrialSite News’ readers have access to unique, transparent coverage of events in the clinical trials industry. We decided, however, to take this even further by providing site-specific, consumer-centric information about various clinical investigational sites. These are sites across the U.S. and internationally that are involved in current clinical trials for new investigative treatments. In this summary, we’ll be covering McLean Hospital in Belmont, Massachusetts, and their role in treating Alzheimer’s disease.
About McLean Hospital
McLean Hospital’s staff of more than 1,900 caring and compassionate individuals focus on the hospital’s mission to deliver compassionate clinical care, conduct innovative scientific discovery, and provide comprehensive professional training and public education. With a rich history spanning over 200 years, McLean is proud to be a leader in mental health. Many groundbreaking milestones in the field of psychiatry have taken place at McLean.
Biogen is the sponsor of this study, which is officially titled “221AD302 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer’s Disease (EMERGE).” Biogen was founded in 1978 as one of the world’s first global biotechnology companies by Charles Weissman, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp, Biogen has led innovative scientific research with the goal over the last decade to defeat devastating neurological diseases.
Study Details and Participation
The primary start date was in September 2015 and was marked as complete in August of 2019. It was previously terminated but physicians and clinical trial leaders recently decided to continue research efforts.
The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with early AD. Secondary objectives are to assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by Mini-Mental State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) [ADAS-Cog 13], and AD Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) [ADCS-ADL-MCI].
It has, as listed on ClinicalTrials.gov, 1638 participants and nearly 200 sites are listed in the trial.
Key Principal Investigator
Our researchers did not find any significant Warning Letters or Inspections from the FDA. You can learn more about their online reputation and the opinions of their patients through their Facebook, Yelp and Google Listing.
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