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Study on Dimethyl Fumarate for Patients with Mild Cognitive Impairment and Alzheimer's Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Alzheimer's disease, a condition that affects memory and thinking skills. The trial will explore the effects of a medication called dimethyl fumarate, which is taken as a capsule. The purpose of the study is to see if this medication can help improve brain health, memory, attention, and daily living activities in people with mild cognitive impairment and dementia due to Alzheimer's disease.

Participants in the study will be randomly assigned to receive either dimethyl fumarate or a placebo. The study will last for about a year, during which participants will take the medication daily. Throughout the study, researchers will assess changes in memory, attention, and other cognitive functions, as well as the overall quality of life and daily activities of the participants. The study will also look at any side effects that may occur.

The trial aims to provide valuable information on whether dimethyl fumarate can be a helpful treatment for improving cognitive functions and quality of life in individuals with Alzheimer's disease. This research could lead to better understanding and management of the disease, potentially offering new hope for those affected by it.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be required to sign an informed consent form. This document confirms the patient's voluntary participation and understanding of the study's procedures and objectives.
Step 2
Initial assessment
The patient will undergo an initial assessment to evaluate cognitive functions. This includes tests to measure memory, attention, thinking, executive, and language functions.
The assessment will also include a review of the patient's medical history and current medications.
Step 3
Medication administration
The patient will receive dimethyl fumarate at a dose of 480 mg daily. This medication is taken orally.
The treatment will continue throughout the study duration, with regular monitoring to assess its effects.
Step 4
Regular monitoring
The patient will attend regular appointments to monitor cognitive functions and overall health. These appointments will include tests and questionnaires to evaluate memory, daily functioning, and quality of life.
The patient's caregiver may also be asked to provide feedback on the patient's condition and any changes observed.
Step 5
Final assessment
At the end of the study, a final assessment will be conducted to evaluate the degree of improvement in cognitive functions.
The results will be compared to those of patients who received a placebo to determine the effectiveness of dimethyl fumarate.

Who can join the trial?

9 criteria

Men and women aged 55-90.
Patients diagnosed with **mild cognitive impairment** in Alzheimer's disease and mild to moderate **dementia** in Alzheimer's disease. This means they have some memory and thinking problems but are still able to do many daily activities.
**MMSE score** from 17 to 30 points. This is a test that checks memory and thinking skills. A score between 17 and 30 is needed.
**CDR score** from 0.5 to 2. This is another test that measures how much memory and thinking problems affect daily life.
The patient must sign an informed, voluntary consent to participate in the study. This means they agree to join the study after understanding what it involves.
The patient has a close person or actual guardian who agrees to help them during the study. This is someone who can support the patient throughout the study.
Minimum 6 years of education. The patient should have completed at least 6 years of schooling.
For anti-Alzheimer's drugs, **cholinesterase inhibitors** are acceptable if they were started at least 3 months before joining the study and used at a stable dose for at least 60 days before joining. These are medications that help with memory and thinking.
For **memantine**, its use is acceptable if it was started at least 4 months before joining the study and used at a stable dose for at least 3 months before joining. This is another type of medication for memory and thinking.

Who cannot join the trial?

5 criteria

Patients who do not have a diagnosis of Alzheimer's disease or Mild Cognitive Impairment (MCI). MCI is a condition where someone has minor problems with memory or thinking, but it is not severe enough to interfere with daily life.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.
Patients who are not able to take the study medication, which is dimethyl fumarate at a dose of 480 mg daily. Dimethyl fumarate is a type of medication used to treat certain conditions.
Patients who are unable to follow the study procedures or attend the required visits.

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Verified sites

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Verified
Instytut Psychiatrii I Neurologii
Warsaw, Poland
Responsive
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
Lodz, Poland

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Investigated drugs

Dimethyl Fumarate is being studied to see if it can help reduce brain atrophy and improve synaptic functional connectivity in patients with mild cognitive impairment and dementia due to Alzheimer's disease. The trial aims to assess whether this medication can enhance cognitive functions such as memory, attention, thinking, executive, and language abilities. Additionally, the study looks at whether it can improve the quality of life and daily activities for these patients.

Dimethyl Fumarate

What is already known about the treatment

Dimethyl Fumarate – This medication is administered orally in the form of capsules. It is currently being studied in clinical trials for its potential benefits in treating Alzheimer's disease, particularly in patients with mild cognitive impairment and dementia. The main therapeutic indication is to improve cognitive functions such as memory, attention, and language skills. At the molecular level, dimethyl fumarate is believed to work by activating the Nrf2 pathway, which helps protect brain cells from damage. It is classified as an immunomodulatory agent, commonly used in other conditions like multiple sclerosis, but its application in Alzheimer's disease is still under investigation.

Investigated diseases

Alzheimer's disease – Alzheimer's disease is a progressive neurological disorder that leads to the degeneration of brain cells, resulting in memory loss and cognitive decline. It typically begins with mild memory lapses and confusion, gradually worsening over time. As the disease progresses, individuals may experience difficulties with language, disorientation, mood swings, and behavioral changes. Eventually, it can impair the ability to carry out daily activities and recognize familiar people and places. The exact cause of Alzheimer's is not fully understood, but it involves the accumulation of abnormal proteins in the brain. It is the most common cause of dementia among older adults.