Understanding Cholinergic Degeneration and Cognitive Fluctuations in Lewy Body Dementia and Parkinsons Disease Dementia

What this Trial Is About

The trial investigates cholinergic degenerations role in cognitive fluctuations in people with Lewy Body Dementia DLB and Parkinson Disease Dementia PDD. It aims to fill knowledge gaps by integrating biomarkers, advanced brain imaging, and EEG assessments to better understand these fluctuations. The study includes cross-sectional comparisons and long-term follow-ups to explore how cognitive fluctuations change over time. Participants include 45 individuals with DLB or PDD who have cognitive fluctuations, 45 Lewy Body disease patients without cognitive fluctuations, and 30 healthy controls. A subset of 20 participants will join an 8-week treatment phase with galantamine, starting with 8mg daily for 4 weeks, then increasing to 16mg daily. Safety and adherence will be checked through phone calls at 2, 4, and 6 weeks. Throughout the study, participants undergo assessments including skin biopsies, multimodal MRI, prolonged EEG monitoring, blood biomarker collection, and cognitive testing. Researchers will measure cognitive fluctuation severity using several scales at baseline, 56 days, and annual follow-ups over two years. Safety monitoring, neuropsychiatric inventories, and sleep behavior questionnaires are also included to track participant well-being and study effects.

Elucidating the Role of Cholinergic Degeneration in Cognitive Fluctuations in Lewy Body Dementia