Alzheimer’s Disease treatment studied by Accel Research Sites approved by FDA

LAKE MARY, Fla., 2021-Jun-19 — /EPR Network/ — Accel Research Sites is proud to announce that a drug studied by the company—ADUHELM™—has been granted accelerated approval by the FDA for the treatment of Alzheimer’s Disease.

Accel Research Sites was a lead enroller of this clinical trial. ADUHELM™ is the first new treatment for Alzheimer’s Disease in nearly 20 years. This treatment is the first medication cleared by U.S. regulators to slow cognitive decline in Alzheimer’s patients. This landmark decision has been eagerly awaited by millions of Americans diagnosed with the condition.

The approved treatment marks the first and only Alzheimer’s Disease medication to address a defining pathology of the disease by reducing harmful clumps of a protein called amyloid beta plaques in the brain. In clinical trials, ADUHELM™ reduced amyloid beta plaques by 59 to 71 percent at 18 months of treatment.

“We’re excited to have played a part in this clinical trial for Alzheimer’s Disease and more importantly to bring a treatment option for patients and families who have so eagerly been awaiting it,” said Dr. Marshall L. Nash, lead investigator on the ADUHELM™ trial. “We want to continue to spread awareness of the importance of clinical trials to bring a cure to Alzheimer’s Disease.”

The effectiveness of ADUHELM™ was assessed in two Phase 3 clinical trials in patients with early stages of Alzheimer’s Disease, including mild cognitive impairment and mild dementia, with confirmed presence of amyloid pathology. The effects of ADUHELM™ were also assessed in the double-blind, randomized, placebo-controlled, dose-ranging Phase 1b study.

Continued approval for ADUHELM™’s indication as a treatment for Alzheimer’s Disease may be contingent upon verification of clinical benefit in confirmatory trial(s).

“I am very fortunate to have worked with such an amazing team on these clinical trials,” said John Holbert, a patient in the ADUHELM™ clinical trial. “I’ve been in the trial for years and the only word to sum up this news is blessed. The doctors and staff have been amazing, very considerate and kind. I have nothing bad to say about them. If you are able to enter a clinical trial, I highly recommend!”

“Accel Research Sites is proud to have been part of the ADUHELM™ clinical trial for Alzheimer’s Disease, and we extend our congratulations to Biogen and Eisai,” said Lora Parahovnik, CEO of Accel Research Sites. “This groundbreaking research gives us a better understanding of the disease so we can continue to learn and develop through clinical trials. Developments like this are clinical trials in action.”

For more information about the launch of ADUHELM™ in the U.S. is available here.

If you are interested in enrolling in a clinical trial or would like to learn more about Accel Research Sites, please visit accelresearchsites.com.

About Accel Research Sites

Accel Research Sites is a multi-therapeutic network of clinical research sites dedicated to the expert delivery of treatment options to patients and providers. They partner with the most innovative and significant pharmaceutical, biotechnology, and medical device companies worldwide to advance healthcare and wellness in the communities they serve.