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Study of Dimethyl Fumarate for Improving Brain Function and Quality of Life in Adults 55 to 90 with Mild Cognitive Impairment and Alzheimers Disease Dementia
Led by Medical University of Lodz · Updated on 2025-02-27
30
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of dimethyl fumarate on cognitive functions, including memory, attention, thinking, executive, and language abilities in people diagnosed with mild cognitive impairment MCI and Alzheimers disease AD. This phase 2 trial involves participants aged 55 to 90 years and aims to compare cognitive improvements between those taking dimethyl fumarate and those receiving a placebo, focusing on scores from the Repeatable Battery for the Assessment of Neuropsychological Status RBANS. Participants will take 480 mg of dimethyl fumarate daily or a placebo. The trial will assess safety, daily functioning using the Alzheimers Disease Cooperative Study - Activity of Daily Living scale ADCS-ADL, neuropsychiatric and behavioral symptoms with the Neuropsychiatric Inventory and Geriatric Depression Scale, and quality of life for patients and caregivers. Brain changes will be monitored with MRI, while functional connections will be evaluated through resting-state fMRI and EEG. Peripheral markers of oxidative stress and inflammation will also be studied. The trial will explore the rate of progression from MCI to dementia and cognitive changes with the MMSE and Clinical Dementia Rating scales. During the 15-month study, participants will undergo cognitive testing, brain imaging, and assessments of daily function, mood, and quality of life. Safety will be closely monitored throughout. Researchers will track changes in brain atrophy and functional brain connections at specified intervals. The trial includes questionnaires and scales to evaluate symptoms and caregiver burden. Participants adherence and health status will be regularly assessed to measure the impact of dimethyl fumarate compared to placebo.
CONDITIONS
Brief Title
Efficacy and Safety of Dimethyl Fumarate Among Patients with Mild Cognitive Impairment and Dementia Due to Alzheimer's Disease
Research Team
M
Medical University of Lodz Medical University of Lodz
J
Jakub Kazmierski, PhD
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