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

Medical University of Lodz1 个研究点分布在 1 个国家目标入组 30 人开始时间: 2024年10月28日最近更新: 2025年2月27日

适应症

干预措施

试验速览

阶段: 2 期
状态: 招募中
发起方: Medical University of Lodz
入组人数: 30
试验地点: 1
主要终点: Change in 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.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 55 Years 至 90 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Men and women aged 55-90 years.
•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.
•MMSE score from 17 to 30 points.
•CDR score from 0.5 to
•The patient signs an informed, voluntary consent to participate in the study.
•The patient has a close person/de facto guardian who agrees to help the patient during participation in the study.
•At least 6 years of education.
•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.

排除标准

•Lack of informed voluntary consent to participate in the study.
•Patients who cannot read or write.
•Pregnant, breastfeeding or childbearing women who do not use effective contraception (hormonal contraception, surgical sterilization, intrauterine device, condom in combination with vaginal spermicide).
•Participation in another clinical trial, currently or within 3 months prior to the screening visit.
•Liver failure (i.e. cirrhosis or active liver disease), diagnosed acute or chronic hepatitis regardless of cause.
•Chronic kidney disease with GFR below < 60 ml/min/m2
•Abnormal liver parameters: ALAT exceeding > 2 times the upper limit of normal
•Leukopenia (<4000/mm3), granulocytopenia (<1500/mm3) or lymphopenia (<1000/mm3) regardless of the cause.
•Severe agitation.
•Mental retardation.
•Delirium diagnosed according to DSM-5 criteria.
•Diagnosis of neurological and neurodegenerative diseases other than Alzheimer's disease (multiple sclerosis, Parkinson's disease, Huntington's disease, previous stroke).
•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.
•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).
•Use of benzodiazepines or barbiturates within 1 week prior to screening.
•Pharmacological immunosuppression.
•Patients with bipolar disorder or psychotic disorders or any other psychiatric condition (current or past) that the Investigator believes interferes with the study.
•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).
•Patients with any medical condition that, in the Investigator's judgment, is an exclusion criterion.
•Thyroid hormone therapy initiated, discontinued, or modified within 3 months prior to screening visit.
•Menopausal hormone replacement therapy initiated, discontinued, or modified within 3 months prior to screening visit.
•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.

研究组 & 干预措施

Assessment of the degree of improvement in cognitive functions in diagnosed patients MCI and AD.

Placebo Comparator

Assessment of 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.