Bolivar patients played a role in clinical trial for a prospective Alzheimer's treatment
Last week, a leading pharmaceutical company shared results of its clinical trial for an Alzheimer's disease treatment. Eli Lilly reported that nearly half of its study participants with early symptomatic Alzheimer's Disease who took its medication donanemab had no cognitive or functional decline for a year, compared to 29% of participants who took a placebo.
The study had about 1,700 participants, including patients at Citizens Memorial Hospital's Missouri Memory Center in Bolivar, according to a press release.
"Results of studies such as this offer hope to patients, families and medical care providers that wrestle with the devastation of Alzheimer’s disease. Options for slowing this unforgiving disease may be on the horizon," said Dr. Curtis P. Schreiber, medical director of the memory center and the CMH research department.
More: Eli Lilly says new Alzheimer's drug donanemab slows early stages of disease by 35%
Schreiber was the principal investigator on the study in Bolivar, which started in 2001.
The study also found that participants on donanemab were 38% less likely to progress to the next stage of the disease compared with those on the placebo.
In a statement, the Alzheimer's Association said the trial had the strongest Phase 3 data to date, and called for the Centers for Medicare and Medicaid Services to "stop blocking access to FDA-approved treatments."
"These are the strongest phase 3 data for an Alzheimer's treatment to date. This further underscores the inflection point we are at for the Alzheimer's field. The progress we've seen in this class of treatments, as well as the diversification of potential new therapies over the past few years, provides hope to those impacted by this devastating disease," said Maria C. Carrillo, Ph.D., Alzheimer's Association chief science officer. "Yet, Medicare stubbornly continues to block access for the people who could benefit."
More: As Missourians age, dementia is expected to increase. Is the state set up to handle it?
According to the Food and Drug Administration, a Phase 3 clinical trial is when an experimental treatment or drug is given to large groups of people. During this trial, researchers confirm whether the experimental treatment is effective, monitor its side effects and compare it to standard or more commonly used treatments. This is the last phase of clinical trials that takes place before a developer can apply for approval from the FDA.
In April 2022, CMS published a national coverage determination that said the specific class of drugs may only be covered if approved by the FDA and if patients received them in a clinical trial. That means that even if approved, donanemab may not be widely available to all Medicare recipients.
Susan Szuch is the health and public policy reporter for the Springfield News-Leader. Follow her on Twitter @szuchsm. Story idea? Email her at sszuch@gannett.com.
This article originally appeared on Springfield News-Leader: Bolivar patients are part of clinical trial for Alzheimer's drug
