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CTAD 2022 | Implementing novel clinical trial designs for dementia with Lewy bodies

Dementia with Lewy bodies (DLB) is a clinically heterogeneous disorder. Patients with DLB can present with a wide variety of symptoms and neuropathologically, DLB can coexist with features of Alzheimer’s disease (AD), TDP-43 proteinopathy, and cerebrovascular disease. These co-pathologies can impact clinical presentation and disease progression. The prodromal stage of DLB is a potential target window for disease-modifying treatment, however little is known about how the disease will progress from this stage. For example, patients with isolated REM sleep behavior disorder can progress to DLB but could also progress to either Parkinson’s disease (PD) or multiple system atrophy (MSA). Carla Abdelnour, PhD, Stanford University, Palo Alto, CA, suggests novel clinical trial designs that could help to overcome some of these challenges. Namely these include adaptive methodologies, which allow for pre-specified modifications to the clinical trial during the period of data collection such as changes to eligibility criteria, endpoints, or patient allocation; and master protocols, whereby a single protocol is used to test multiple therapies and/or multiple diseases simultaneously. These innovative designs could improve the efficiency of DLB clinical trials. This interview took place at the Clinical Trials on Alzheimer’s Disease congress 2022 in San Francisco.

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Carla Abdelnour reports the following disclosures:
I’m a board member of the Lewy Body Dementia Association (LBDA), and I have received honoraria for presentations from F. Hoffmann-La Roche Ltd, Zambon, Nutricia and Schwabe Farma Ibérica S.A.U.