NCT06850597 Efficacy and Safety of Dimethyl Fumarate Among Patients with Mild Cognitive Impairment and Dementia Due to Alzheimer's Disease
| NCT ID | NCT06850597 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Medical University of Lodz |
| Condition | MCI |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-10-28 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2024-10-28 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Men and women aged 55-90 years. 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: 1. Lack of informed voluntary consent to participate in the study. 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06850597 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, up to 90 Years, studying MCI. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06850597 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06850597 currently recruiting?
Yes, NCT06850597 is actively recruiting participants. Contact the research team at cwbk@umed.lodz.pl for enrollment information.
Where is the NCT06850597 trial being conducted?
This trial is being conducted at Lodz, Poland.
Who is sponsoring the NCT06850597 clinical trial?
NCT06850597 is sponsored by Medical University of Lodz. The trial plans to enroll 30 participants.