2024-517214-16-00
Recruiting
Phase 2
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 Lodz3 sites in 1 country100 target enrollmentStarted: November 5, 2024Last updated:
Overview
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Medical University Of Lodz
- Enrollment
- 100
- Locations
- 3
- Primary Endpoint
- Change in cognitive performance as assessed by RBANS scores between the post-treatment visit (V9) and the randomisation visit (V1).
Overview
Brief Summary
Assessment of the degree of improvement in cognitive functions, including memory, attention, thinking, executive and language functions in patients diagnosed with MCI and AD receiving dimethyl fumarate at a dose of 480 mg daily compared to patients taking placebo
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men and women aged 55-
- •Patients diagnosed with mild cognitive impairment in Alzheimer's disease and mild to moderate dementia in Alzheimer's disease (MMSE> 16) diagnosed according to NIA-AA criteria.
- •MMSE score from 17 to 30 points.
- •CDR score from 0.5 to
- •Signing by the patient of informed, voluntary consent to participate in the study.
- •The patient has a close person / actual guardian who agrees to help the patient during the participation in the study.
- •Minimum 6 years of education.
- •For anti-Alzheimer's drugs, cholinesterase inhibitors are acceptable were included at least 3 months prior to study inclusion and used at a stable dose for at least 60 days prior to study inclusion. For memantine, its use is acceptable when it is included at least 4 months prior to study inclusion and used at a stable dose for at least 3 months prior to study inclusion.
Exclusion Criteria
- •Lack of informed consent to participate in the study.
- •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 MRI haemorrhagic foci ≥ 2 cm3 in diameter, more than three (3) ischemic foci ≥ 1.5 cm3 in diameter or a single ischemic focus ≥ 2 cm3, presence of vascular malformations, aneurysms, subdural hematoma, normotensive hydrocephalus, the final decision is at the discretion of the researcher.
- •Severe or uncontrolled physical disease that could interfere with the course of the study (e.g., cancer, cardiovascular, respiratory, metabolic or digestive, severe renal failure, unstable type I or II diabetes, untreated or uncontrolled clinically significant arterial hypertension) .
- •Use of benzodiazepines or barbiturates one week prior to screening.
- •Pharmacological immunosuppression.
- •Patients with bipolar disorder or psychotic disorder or any other psychiatric condition (current or past) that the Investigator considers to be interfering with the study.
- •Alcoholism, benzodiazepine dependence or drug dependence as defined by DSM-5 in the last 5 years (addicted for more than one year and or in remission for less than 3 years).
Outcomes
Primary Outcomes
Change in cognitive performance as assessed by RBANS scores between the post-treatment visit (V9) and the randomisation visit (V1).
Change in cognitive performance as assessed by RBANS scores between the post-treatment visit (V9) and the randomisation visit (V1).
Secondary Outcomes
- Assessment of the daily functioning of patients based on the ADCS-ADL scale
- Assessment of the presence of neuropsychiatric symptoms / behavioral disorders in patients using the NPI, GDS scale),
- Assessment of the quality of life of patients and their caregivers based on the EQ-5D scales, Zarit Burden Interview,
- Assessment of the expression of peripheral markers of oxidative stress and pro-inflammatory markers.
- Improvement of cognitive functions using MMSE, CDR in patients diagnosed with MCI and AD receiving dimethyl fumarate after the end of therapy compared to the placebo group.
- Difference in frequency and severity of reported adverse events in the active group versus the placebo group.
Investigators
Jakub Kaźmierski
Scientific
Medical University Of Lodz
Study Sites (3)
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