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.
Men and women aged 55-90 years.
Patients diagnosed with mild cognitive impairment in Alzheimer's disease and mild to moderate Alzheimer's dementia (MMSE >16) diagnosed based on NIA-AA criteria.
MMSE score from 17 to 30 points.
CDR score from 0.5 to 2.
Lack of informed voluntary consent to participate in the study.
Patients who cannot read or write.
Pregnant, breastfeeding or childbearing women who do not use effective contraception (hormonal contraception, surgical sterilization, intrauterine device, condom in combination with vaginal spermicide).
Participation in another clinical trial, currently or within 3 months prior to the screening visit.
Parallel
dimethyl fumarate
Drug480 mg per day
10
Treatment groupsSee each treatment group below.
Change 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.
Assessment of the safety of therapy
Assessment of the impact of therapy on the daily functioning of patients - Alzheimer's Disease Cooperative Study - Activity of Daily Living (ADCS-ADL) scale.
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).
Assessment of the impact of therapy on the quality of life of patients and their caregivers (EQ-5D scales; Zarit Burden Interview).
Assessment of the effect of therapy on peripheral markers of oxidative stress and pro-inflammatory markers.
Assessment of the degree of reduction of the MCI progression rate to dementia after the end of the clinical phase of the study.
Assessment of the degree of improvement of cognitive functions using the MMSE and CDR scales.
MMSE (Mini-Mental State Examination) score from 17 to 30 points CDR (The Clinical Dementia Rating) score from 0,5 to 2 points
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