RecruitingPhase 2NCT06850597

Efficacy and Safety of Dimethyl Fumarate Among Patients with Mild Cognitive Impairment and Dementia Due to Alzheimer's Disease

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

Sponsor

Medical University of Lodz

Enrollment

30 participants

Start Date

Oct 28, 2024

Study Type

INTERVENTIONAL

Conditions

MCI MCI-AD, Early Stage Alzheimer's Disease

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

Min Age: 55 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether dimethyl fumarate (DMF) — a drug currently used for multiple sclerosis and psoriasis — can slow cognitive decline or improve symptoms in people with mild cognitive impairment or mild-to-moderate Alzheimer's disease, by reducing brain inflammation. **You may be eligible if...** - You are between 55 and 90 years old - You have been diagnosed with mild cognitive impairment due to Alzheimer's disease, or mild to moderate Alzheimer's dementia - Your score on the MMSE (standard memory test) is between 17 and 30 - Your CDR (Clinical Dementia Rating) score is between 0.5 and 2 - You have a close person (family member or caregiver) who can support your participation - You are willing and able to provide written informed consent **You may NOT be eligible if...** - Your dementia is severe (MMSE below 17) - Your cognitive problems are caused by a condition other than Alzheimer's disease - You have significant kidney, liver, or heart problems - You are currently on immunosuppressant medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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