Almost 1 million people face Parkinson’s disease, and about 50 percent of these people experience dementia symptoms. Currently, there is only one treatment option for the nearly 500,000 patients affected by dementia symptoms of PD. There is a high need to discover additional, better treatment options for Parkinson’s disease dementia, and the only way to address that is through clinical trial research. The primary goal of clinical trial research is to determine the safety and efficacy of new treatments, however, they can be intimidating to get involved in. We asked Dr. Hans Moebius, Chief Medical Officer at Athira Pharma, to provide some guidance. Here is what he had to say:
“Before a new treatment can be offered to the public, it must be approved by the FDA. But in order to get FDA approval, the treatment must first be shown to be safe and effective through several phases of clinical trials with study volunteers. In turn, these clinical trials can only be started on the basis of extensive pre-clinical research to ensure the safety of new research compounds. Though one of the primary goals is to advance medicines and get new treatments to those that need them, there are many other reasons to participate in clinical trials:
Why Participate in Clinical Trials?
One of the largest benefits of participating in a clinical trial is potentially getting access to a cutting-edge treatment before it’s widely available. If the standard of care is not enough for the affected patient, clinical trial participation may be a good fit.
When taking part in a clinical trial, physicians closely monitor the participant to assess safety and efficacy. During the study period, the participant will be empowered to be actively involved in their own care while receiving a high standard of care from the physicians and nursing staff, free of charge.
Even if the clinical trial does not result in an FDA-approved treatment, every step taken to contribute to medical advancements through clinical research will help the scientific community reach the common goal of improving the treatment options for future generations.
The treatment options available will never improve unless volunteers continue to participate in clinical trials. Patients and their caregivers are not only the most important part of clinical research but through clinical trial participation, they can actively take part in improving their own healthcare.
How to Participate in Clinical Trials
In order of priority, here are some steps potential clinical trial participants and their caregivers should take to get involved:
- Talk to the patient’s primary care physician or health care team for clinical trial consideration and ask for recommendations.
- Research clinical trials listed by national/local patient advocacy groups such as the Michael J Fox Foundation.
- Reference www.clinicaltrials.gov to learn more about clinical trials in-depth.
Although there are several reasons to participate in clinical trials, patients and family members should make an informed decision to participate based on doctor recommendations, time commitment of the study, and family life factors.”
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Athira Pharma is currently conducting a Phase 2 study of a new investigational drug, fosgonimeton, the SHAPE trial, which is testing whether the treatment is safe and effective in improving symptoms of Parkinson’s disease dementia and dementia with Lewy bodies. Fosgonimeton is designed to boost a naturally occurring regenerative pathway for brain cells, promoting brain health and function.
If you are looking for a clinical trial, consider the SHAPE trial: www.shapetrial.com.
Hans Moebius, MD (FAAN), PhD
Chief Medical Officer, Athira Pharma, Inc.
Medical Disclaimer: Dr. Moebius’s comments are not prescriptive advice and do not supplant the directions of your treating physician. His views are his alone, based on years of practice and experience, and do not represent the views of his employer or any other organization. Always make medical decisions only under the guidance of your treating doctor.