Alzheimer

Project title: 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.

Project data

Project financing: 9 968 771,73 PLN (including financing for UMED: 6 865 478,73 PLN), financed by the Medical Research Agency (ABM) - ABM/2021/2

Project description:

The aim of the project is to evaluate the efficacy and safety of dimethyl fumarate in reducing cerebral atrophy, improving synaptic functional connections, cognitive functions as well as functioning and quality of life of patients diagnosed with mild cognitive impairment and dementia in Alzheimer’s disease.

Alzheimer’s Disease (AD) is the most common cause of dementia accounting for 60-75% of all cases. People with AD experience a progressive decline in cognitive abilities, including memory, logical thinking and social skills. The number of people in Poland with Alzheimer-type dementia is estimated at 360 000 to 470 000. Such a large medical problem generates enormous economic and social costs.

Available treatments are symptomatic and their effectiveness is severely limited. Despite numerous studies on new molecules that could find their way into effective AD therapy, no new formulas have been launched on the market yet. The investigational medicinal product dimethyl fumarate is a methyl ester of fumaric acid with potent antioxidant, anti-inflammatory and immunomodulatory effects. The therapy aims to intervene in part of the mechanisms responsible for the development of dementia, thereby inhibiting the progression of mild cognitive impairment to dementia and inhibiting the development of already present dementing symptoms.

The project is being carried out by the Medical University of Łódź in partnership with the Independent Public Healthcare Centre of the Central Clinical Hospital of the Medical University of Łódź, the Medical University of Silesia in Katowice and the Institute of Psychiatry and Neurology in Warsaw.

Beneficiary

Consortium composed of:

Medical University of Lodz (Leader)

The Central Teaching Hospital of the Medical University of Lodz (Partner)

Medical University of Silesia in Katowice (Partner)

Institute of Psychiatry and Neurology in Warsaw (Partner)

Coordinating Principal Investigator

Prof. Jakub Kaźmierski, MD, PhD

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