Actively Recruiting
Randomized, Double-blind, Placebo-Controlled Trial Evaluating Dimethyl Fumarate for Brain Atrophy, Cognitive Function, and Quality of Life in Mild Cognitive Impairment and Alzheimer's Disease
Led by Medical University of Lodz · Updated on 2025-02-27
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
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 Alzheimer's 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 Alzheimer's 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 55 to 90 years
- Diagnosed with mild cognitive impairment or mild to moderate Alzheimer's dementia (MMSE score 17 to 30)
- Clinical Dementia Rating score from 0.5 to 2
- Signed informed consent to participate
- Has a close person or guardian to assist during the study
- At least 6 years of education
- Stable use of cholinesterase inhibitors or memantine for the required time before study entry
You will not qualify if you...
- Lack of informed consent
- Inability to read or write
- Pregnant, breastfeeding, or childbearing women not using effective contraception
- Participation in another clinical trial currently or within 3 months prior
- Liver failure or active liver disease
- Chronic kidney disease with GFR below 60 ml/min/m2
- Abnormal liver enzyme levels exceeding twice the normal limit
- Low blood cell counts (leukopenia, granulocytopenia, lymphopenia)
- Severe agitation or mental retardation
- Delirium as per DSM-5 criteria
- Other neurological or neurodegenerative diseases besides Alzheimer's
- Significant brain lesions or vascular abnormalities on MRI
- Severe or uncontrolled somatic diseases such as cancer, cardiovascular, respiratory, metabolic, or digestive diseases
- Recent use of benzodiazepines or barbiturates
- Pharmacological immunosuppression
- Bipolar disorder, psychotic disorders, or interfering psychiatric conditions
- Alcoholism or drug addiction within past 5 years
- Thyroid or menopausal hormone therapy changes within 3 months
- Use of prohibited drugs such as antineoplastic, immunosuppressive drugs, corticosteroids, live attenuated vaccines, benzodiazepines, or other ethyl esters
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 15 months
Participants take dimethyl fumarate 480 mg daily or placebo to evaluate cognitive function, brain atrophy, daily functioning, neuropsychiatric symptoms, and quality of life.
Regular visits during treatment period
Trial Site Locations
Total: 1 location
1
Department of Old Age Psychiatry and Psychotic Disorders Medical University of Lodz
Lodz, Łódź Voivodeship, Poland, 92-213
Actively Recruiting
Research Team
M
Medical University of Lodz Medical University of Lodz
J
Jakub Kazmierski, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
10
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