Actively Recruiting
Efficacy and Safety of Dimethyl Fumarate Among Patients with Mild Cognitive Impairment and Dementia Due to Alzheimer's Disease
Led by Medical University of Lodz · Updated on 2025-02-27
30
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 55-90 years
- Diagnosed with mild cognitive impairment in Alzheimer's disease or mild to moderate Alzheimer's dementia (MMSE >16) based on NIA-AA criteria
- MMSE score between 17 and 30 points
- CDR score between 0.5 and 2
- Signed informed voluntary consent to participate
- Has a close person or guardian to assist during the study
- At least 6 years of education
- Use of cholinesterase inhibitors allowed if started at least 3 months before study entry and stable for 60 days
- Use of memantine allowed if started at least 4 months before study entry and stable for 3 months
You will not qualify if you...
- No informed voluntary consent
- Unable 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
- Elevated liver enzymes (ALAT > 2 times upper limit)
- Low blood cell counts (leukopenia, granulocytopenia, lymphopenia)
- Severe agitation
- Mental retardation
- Delirium diagnosed by DSM-5 criteria
- Neurological diseases other than Alzheimer's (e.g., multiple sclerosis, Parkinson's, Huntington's, stroke)
- Brain abnormalities on MRI such as hemorrhagic foci or vascular malformations
- Severe or uncontrolled somatic diseases affecting study course
- Use of benzodiazepines or barbiturates within 1 week prior to screening
- Pharmacological immunosuppression
- Bipolar disorder, psychotic disorders, or other interfering psychiatric conditions
- Alcoholism or drug addiction within past 5 years
- Any medical condition judged by investigator to exclude participation
- Recent changes in thyroid hormone or menopausal hormone therapy within 3 months
- Use of prohibited drugs such as antineoplastics, immunosuppressives, corticosteroids, or live vaccines
AI-Screening
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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
CONTACT
J
Jakub Kazmierski, PhD
CONTACT
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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