Efficacy and Safety of Dimethyl Fumarate Among Patients with Mild Cognitive Impairment and Dementia Due to Alzheimer's Disease
NCT ID: NCT06850597
Last Updated: 2025-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2024-10-28
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
dimethyl fumarate
480 mg per day
Assessment of the safety of therapy
Assessment of the safety of therapy
dimethyl fumarate
480 mg per day
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).
dimethyl fumarate
480 mg per day
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).
dimethyl fumarate
480 mg per day
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).
No interventions assigned to this group
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)
dimethyl fumarate
480 mg per day
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
dimethyl fumarate
480 mg per day
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
dimethyl fumarate
480 mg per day
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
dimethyl fumarate
480 mg per day
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
dimethyl fumarate
480 mg per day
Interventions
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dimethyl fumarate
480 mg per day
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. MMSE score from 17 to 30 points.
4. CDR score from 0.5 to 2.
5. The patient signs an informed, voluntary consent to participate in the study.
6. The patient has a close person/de facto guardian who agrees to help the patient during participation in the study.
7. At least 6 years of education.
8. 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.
Exclusion Criteria
2. Patients who cannot read or write.
3. Pregnant, breastfeeding or childbearing women who do not use effective contraception (hormonal contraception, surgical sterilization, intrauterine device, condom in combination with vaginal spermicide).
4. Participation in another clinical trial, currently or within 3 months prior to the screening visit.
5. Liver failure (i.e. cirrhosis or active liver disease), diagnosed acute or chronic hepatitis regardless of cause.
6. Chronic kidney disease with GFR below \< 60 ml/min/m2
7. Abnormal liver parameters: ALAT exceeding \> 2 times the upper limit of normal
8. Leukopenia (\<4000/mm3), granulocytopenia (\<1500/mm3) or lymphopenia (\<1000/mm3) regardless of the cause.
9. Severe agitation.
10. Mental retardation.
11. Delirium diagnosed according to DSM-5 criteria.
12. Diagnosis of neurological and neurodegenerative diseases other than Alzheimer's disease (multiple sclerosis, Parkinson's disease, Huntington's disease, previous stroke).
13. Presence of hemorrhagic foci in magnetic resonance imaging with a diameter of ≥ 2 cm3, more than three (3) ischemic stroke foci with a diameter of ≥ 1.5 cm3 or a single ischemic foci with a diameter of ≥ 2 cm3, presence of vascular malformations, aneurysms, subdural hematoma, normal pressure hydrocephalus, final decision at the discretion of the investigator.
14. Severe or uncontrolled somatic disease that could affect the course of the study (e.g. neoplastic, cardiovascular, respiratory, metabolic or digestive, severe renal failure, unstable type I or II diabetes, untreated or uncontrolled clinically significant hypertension).
15. Use of benzodiazepines or barbiturates within 1 week prior to screening.
16. Pharmacological immunosuppression.
17. Patients with bipolar disorder or psychotic disorders or any other psychiatric condition (current or past) that the Investigator believes interferes with the study.
18. Alcoholism or drug addiction as defined by DSM-5 within the past 5 years (dependent for more than 1 year and or in remission for less than 3 years).
19. Patients with any medical condition that, in the Investigator's judgment, is an exclusion criterion.
20. Thyroid hormone therapy initiated, discontinued, or modified within 3 months prior to screening visit.
21. Menopausal hormone replacement therapy initiated, discontinued, or modified within 3 months prior to screening visit.
22. Use of prohibited drugs in the study: Antineoplastic drugs (no studies). Immunosuppressive drugs (no studies). Corticosteroids (impact on project results). Live attenuated vaccines (no studies). Inactivated vaccines may be used. Benzodiazepines (impact on assessed endpoints). Other ethyl esters used orally or topically.
55 Years
90 Years
ALL
Yes
Sponsors
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Medical University of Lodz
OTHER
Responsible Party
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Jakub Kazmierski
MD, PhD, Professor
Locations
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Department of Old Age Psychiatry and Psychotic Disorders Medical University of Lodz
Lodz, Łódź Voivodeship, Poland
Countries
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Central Contacts
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Facility Contacts
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Jakub Kaźmierski
Role: primary
Other Identifiers
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2022-002171-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
010622
Identifier Type: -
Identifier Source: org_study_id
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