December 06, 2020
To improve the landscape of clinical trials involving patients with Lewy body dementia, which includes dementia with Lewy bodies as well as Parkinson disease dementia, the Lewy Body Dementia Association launched an Industry Advisory Council. In June 2019, the council held its inaugural meeting, which included representatives from regulatory agencies, explained a review article in Alzheimer’s Research & Therapy.
“Partnership and consultation across patients, clinicians, researchers, industry, and government agencies on trial design and regulatory guidance regarding [the] US Food and Drug Administration will be vital for the future of Lewy body dementia trials,” the wrote lead author Jennifer G. Goldman, MD, section chief of the Parkinson’s Disease and Movement Disorders Program at Northwestern University Feinberg School of Medicine, and coauthors.
Only two medications are currently approved for Lewy body dementia, and a multitude of challenges currently hamper clinical trials to develop more. These include a lack of standardized clinical assessment tools and limited evidence-based management strategies for patients.
“The heterogeneity of Lewy body dementia symptoms and presentations not only make a uniform standard of care difficult,” the authors wrote, “but also underlie some clinical trial design challenges regarding study focus, subject criteria, and outcome measures.”
Demands of study participation, such as travel, in-person visits, and duration, also hinder study enrollment and retention, as well as outcomes. Participants are often male, younger, Caucasian, healthier, and wealthier, according to the paper, which may limit generalizability of study findings.
However, efforts such as harmonizing clinical assessment tools, establishing standardized biomarkers, and better engaging the patient community could help advance the field, experts believe.
“In summary, there are challenges,” the authors wrote, “but also opportunities for clinical trials in Lewy body dementia.”
Goldman JG, Forsberg LK, Boeve BF, et al. Challenges and opportunities for improving the landscape for Lewy body dementia clinical trials. Alzheimers Res Ther. 2020;12(1):137. Published 2020 Oct 29. doi:10.1186/s13195-020-00703-5