Testing dimethyl fumarate for improving cognitive functions in Alzheimer's patients

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

This study is testing if a medication called dimethyl fumarate can help improve memory and thinking skills in older adults with mild cognitive impairment and early-stage Alzheimer's disease.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 55 Years to 90 Years
• Sex: All
• Sponsor: Medical University of Lodz (Academic / other)
• Locations: 1 site (Lodz, Łódź Voivodeship)
• Trial ID: NCT06850597 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of dimethyl fumarate in patients aged 55 to 90 diagnosed with mild cognitive impairment and early-stage Alzheimer's disease. Participants will receive either dimethyl fumarate or a placebo, and their cognitive functions will be assessed using the RBANS score to determine any improvements in memory, attention, and other cognitive abilities. The study will focus on comparing the outcomes between the treatment and placebo groups to establish the potential benefits of the medication.

Who should consider this trial

Good fit: Ideal candidates are men and women aged 55-90 with a diagnosis of mild cognitive impairment or mild to moderate Alzheimer's dementia.

Not a fit: Patients with severe cognitive impairment or those not meeting the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could lead to improved cognitive functions in patients with mild cognitive impairment and Alzheimer's disease.

How similar studies have performed: While there have been studies on cognitive enhancers, the specific use of dimethyl fumarate in this context is relatively novel and untested.

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.

Where this trial is running

Lodz, Łódź Voivodeship

• Department of Old Age Psychiatry and Psychotic Disorders Medical University of Lodz — Lodz, Łódź Voivodeship, Poland (Recruiting)

Study contacts

• Study coordinator: Medical University of Lodz Medical University of Lodz

Conditions MCI; MCI-AD, Early Stage Alzheimer's Disease; Alzheimer's Disease