The goal of this clinical trial is to assess the degree of improvement in cognitive functions, including memory, attention, thinking, executive and language functions in diagnosed patients MCI and AD taking dimethyl fumarate 480 mg daily compared to patients taking placebo. Participant will be 55 to 90 years old, both genders. The main question it aims to answer is: Changing the degree of cognitive improvement based on the RBANS score among patients diagnosed with MCI and AD after completing dimethyl fumarate therapy test group compared to the placebo group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
480 mg per day
Department of Old Age Psychiatry and Psychotic Disorders Medical University of Lodz
Lodz, Łódź Voivodeship, Poland
RECRUITINGChange in the degree of cognitive improvement based on the RBANS score among patients diagnosed with MCI and AD after completing dimethyl fumarate therapy test group compared to the placebo group.
The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) is a neuropsychological measure used in the assessment of cognitive function in older adults, studies of mild cognitive impairment and Alzheimer's disease dementia, and studies evaluating the effectiveness of therapeutic interventions. The test generates index scores in five neurocognitive domains, as well as a Total Scale Index score. The RBANS is characterized by high sensitivity in detecting disease and assessing changes in scores during treatment in patients with MCI in the course of Alzheimer's disease. with MCI and AD after completing dimethyl fumarate therapy test group compared to the placebo group.
Time frame: 15 months
Assessment of the safety of therapy
Time frame: 15 months
Assessment of the impact of therapy on the daily functioning of patients - Alzheimer's Disease Cooperative Study - Activity of Daily Living (ADCS-ADL) scale.
Time frame: 15 months
Assessment of the impact of therapy on the presence of neuropsychiatric symptoms/behavioral disorders in patients using the Neuropsychiatric Inventory (NPI) scale and the Geriatric Depression Scale (GDS).
Time frame: 15 months
Assessment of the impact of therapy on the quality of life of patients and their caregivers (EQ-5D scales; Zarit Burden Interview).
Time frame: 12 months
Assessment of the effect of therapy on the reduction of the degree of brain atrophy in patients from the active group compared to the control group (MRI study).
Time frame: 6 months
Assessment of the effect of therapy on the improvement of functional connections assessed in rs-fMRI and rs-EEG.
EEG and MRI data will be processed using standard processing pipelines. The results will be a topographic map of the EEG frequency band distribution on the brain surface, temporal and time-frequency analyses based on FFT and wavelets, entropy analysis, and EEG coherence markers. Then, inverse localization of EEG signals generated on the scalp over the brain surface will be performed. Particular emphasis will be put on frontal structures and areas detected by MRI clustering. We will perform machine learning-based clustering of EEG and MRI data to detect significant features. CDR "Clinical Dementia Rating Assessment" score from 0.5 to 2
Time frame: 15 months
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