Alzheimer - FuDiMe

Information about the drug that will be tested in the study

Administration

Oral capsule twice daily

Is the drug already on the market for another medical condition?

Yes, relapsing-remitting multiple sclerosis

Will all participants receive the same drug?

Participants will be selected by chance to receive one of the following options:

• Capsule of dimethyl fumarate (240 mg twice daily)
• Capsule of placebo (also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested with no active therapeutic effect).

Neither the participant nor their doctor will know if the person is receiving the investigational drug or the placebo.

Information about participating in the trial

What are the researchers trying to find out?

The purpose of the study is to evaluate the effects and safety of dimethyl fumarate in people with mild cognitive impairment and dementia due to Alzheimer’s disease.

How long will the treatment last?

• Around 1 year

What your involvement will entail?

• During the study, participants will be asked to complete some tests that will assess their cognition, behaviour, function, neuropsychiatric symptoms and activities of daily living (RBANS, MMSE, CDR, NPI, GDS, ADCS-ADL)
• Complete some laboratory tests and neurological examination to evaluate the emergent adverse events (unfavourable signs, symptoms or diseases temporally associated with the use of the drug tested in the study).

Further information on the procedures, tests and number of visits can be obtained from the study team.

Who can participate in this study?

Who can participate in the study?

To take part in the study, participants must:

• Be between 55 and 90 years old
• Have a diagnosis of mild cognitive impairment in Alzheimer's disease and mild to moderate dementia in Alzheimer's disease, according to NIA-AA criteria
• Have a score from 0.5 to 2 in the CDR score and between 17-30 in the MMSE score. This would suggest that the person has an impairment in their memory that is at a mild to moderate stage
• Have a study partner who has a sufficient contact with the participant, is willing to participate in study procedures throughout the study duration
• If the person is taking an approved anti-dementia medication (i.e. donepezil, rivastigmine, galantamine) the dosing regimen must have been stable for at least 2 months weeks prior to the study inclusion. For memantine, its use is acceptable for at least 3 months prior to study inclusion.

Who cannot participate in the study?

People cannot take part in the study if they have or have experienced:

• Diagnosis of delirium, bipolar or psychotic disorder
• Diagnosis of neurological and neurodegenerative diseases other than Alzheimer's disease (e.g. multiple sclerosis, Parkinson's disease, Huntington's disease, previous stroke)
• A disease or condition that may interfere with the safety, tolerability and/or study assessments (e.g., cancer, cardiovascular, respiratory, metabolic or digestive, severe renal failure, unstable diabetes, untreated or uncontrolled clinically significant arterial hypertension)
• History of alcohol or drug abuse
• Pregnancy or breastfeeding
• Participation in another clinical trial within 3 months before the screening visit.

The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.

Information for your doctor

EuCT Number

2024-517214-16-00

Study contact information

Jakub Kaźmierski jakub.kazmierski@umed.lodz.pl

Katarzyna Wiklak-Mrowińska katarzyna.wiklak-mrowinska@umed.lodz.pl

Link to full text

https://euclinicaltrials.eu/ctis-public/view/2024-517214-16-001 

The information contained in this document is based on information available on public registries (e.g. CTIS website) in November 2024.

This document has been reviewed by the pharmaceutical company running this trial.

This document has been reviewed by a member of the European Dementia Carers Working Group.