To help ensure our readers can make the most well-informed decisions regarding their health and medical treatments, TrialSite News is providing complete summaries of various clinical investigation sites. These sites are part of current clinical trials, and we’ll be covering the quality of care at these sites, their physicians’ reputation and the details of the trials they are involved in. So far, we’ve reviewed clinical investigation sites that are treating NASH and prostate cancer. In this summary, we’ll be researching Josephson, Wallack, Munshower Neurology treating Alzheimer’s Disease.
About Josephson, Wallack, Munshower (JWM) Neurology
As mentioned on their website, “JWM Neurology is a premier group of Neurologists and Sleep Medicine physicians in Indianapolis, Indiana. [They] treat patients with all types of neurological conditions and sleep disorders. The neurologists at JWM Neurology are specially trained physicians who diagnose, treat and manage adult and pediatric patients who have all types of neurologic diseases and conditions. [Their] physicians also conduct neurologic-related clinical research trials through the JWM Neurology Research Center, enabling us to offer the latest treatment options available.”
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
With 12 locations in the Indianapolis and central Indiana area, TrialSite researchers were unable to identify the principal investigator at JWM Neurology. However, JWM Neurology has a research department that has been in operation since 2005 and is directed by Craig Herrman, MD. They also have a dedicated Research Manager and three specially trained clinical study coordinators who assist their physicians with the recruitment of and conducting the clinical trials. Their research department has participated in clinical trials for a vast array of neurologic diagnoses including but not limited to:
- Multiple Sclerosis
- Alzheimer’s disease
- Chronic Pain
- Restless Leg Syndrome
We invite you to learn more about their research department here.
Upon our initial inspection, we found no Warning Letters or Inspections from the FDA. This means, ideally, they are adhering to regulations and laws pertaining to their practices. For more information on what their patients have to say, we invite you to review their Facebook page, Yelp page and various Google Listings.
Call to Action: Is there a specific clinical investigation site treating Alzheimer’s Disease that you’re interested in? Reach out to TrialSite News, and we’ll be happy to provide you with more information.