Randomized, Double-blind, Placebo- Controlled Trial Evaluating Efficacy and Safety of Dimethyl Fumarate in Brain Atrophy Reduction, Synaptic Functional Connectivity, Cognitive Functions, Quality of Life, and Activity of Daily Living Improvement Among Patients with Mild Cognitive Impairment and Dementia Due to Alzheimer's Disease
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 90
Healthy Volunteers: t
View:
• 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.
• The patient signs an informed, voluntary consent to participate in the study.
• The patient has a close person/de facto guardian who agrees to help the patient during participation in the study.
• At least 6 years of education.
• In the case of anti-Alzheimer's drugs, the use of cholinesterase inhibitors is permitted provided that they are included at least 3 months before entering the study and used at a stable dose for at least 60 days before entering the study. In the case of memantine, its use is permitted provided that it is included at least 4 months before entering the study and used at a stable dose for at least 3 months before entering the study.
Locations
Other Locations
Poland
Department of Old Age Psychiatry and Psychotic Disorders Medical University of Lodz
RECRUITING
Lodz
Contact Information
Primary
Medical University of Lodz Medical University of Lodz
cwbk@umed.lodz.pl
+48 422725239
Backup
Jakub Kazmierski, PhD
jakub.kazmierski@umed.lodz.pl
+48 426757372
Time Frame
Start Date:2024-10-28
Estimated Completion Date:2027-12-31
Participants
Target number of participants:30
Treatments
Placebo_comparator: Assessment of the degree of improvement in cognitive functions in diagnosed patients MCI and AD.
Assessment of 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.
Other: Assessment of the safety of therapy
Assessment of the safety of therapy
Placebo_comparator: Assessment of the impact of therapy on patients' daily functioning
Assessment of the impact of therapy on patients' daily functioning - Scale Alzheimer's Disease Cooperative Study - Activity of Daily Living (ADCS-ADL).
Placebo_comparator: Assessment of the impact of therapy on the presence of symptoms neuropsychiatric/behavioral disorder
Assessment of the impact of therapy on the presence of symptoms neuropsychiatric/behavioral disorders in patients scale Neuropsychiatric Inventory (NPI), Geriatric Depression Scale (GDS).
Placebo_comparator: Assessment of the impact of therapy on the quality of life of patients and their caregivers
Assessment of the impact of therapy on the quality of life of patients and their caregivers (scales EQ-5D; Zarit Burden Interview).
Placebo_comparator: reducing the degree of brain atrophy in patients - MRI examination
Assessment of the impact of therapy on reducing the degree of brain atrophy in patients from the active group compared to the control group (MRI examination)
Placebo_comparator: impact of therapy on improvement in functional connections assessed in rs-fMRI rs-EEG
Assessment of the impact of therapy on improvement in functional connections assessed in rs-fMRI and rs-EEG
Placebo_comparator: Effect of therapy on peripheral markers of oxidative stress and pro-inflammatory markers
Assessment of the effect of therapy on peripheral markers of oxidative stress and pro-inflammatory markers
Placebo_comparator: degree of reduction in the rate of progression from MCI to dementia after completion
Assesment of the degree of reduction in the rate of progression from MCI to dementia after completion of the clinical phase of the study
Placebo_comparator: degree of improvement in cognitive functions using the MMSE and CDR scales
Assessment of the degree of improvement in cognitive functions using the MMSE and CDR scales