DIMETHYL FUMARATE for Mild cognitive impairment | Dementia due to Alzheimer's disease | Alzheimer's disease

Inclusion criteria

• {"criterion_text":"- Men and women aged 55-90."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- MMSE score from 17 to 30 points."}
• {"criterion_text":"- CDR score from 0.5 to 2."}
• {"criterion_text":"- Signing by the patient of informed, voluntary consent to participate in the study."}
• {"criterion_text":"- The patient has a close person / actual guardian who agrees to help the patient during the participation in the study."}
• {"criterion_text":"- Minimum 6 years of education."}
• {"criterion_text":"- 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

• {"criterion_text":"- Lack of informed consent to participate in the study."}
• {"criterion_text":"- Inability to read or write."}
• {"criterion_text":"- Women who are pregnant, breastfeeding or of childbearing age not using effective contraception (hormonal contraception, surgical sterilization, intrauterine device, condom in combination with vaginal spermicide)."}
• {"criterion_text":"- Participation in another clinical trial, currently or within 3 months before the screening visit."}
• {"criterion_text":"- Liver failure (ie cirrhosis or active liver disease), diagnosed acute or chronic hepatitis, regardless of the cause."}
• {"criterion_text":"- Chronic kidney disease with elevated serum creatinine value > 115umol/l (1,3 mg/dL)."}
• {"criterion_text":"- Abnormal results of hepatic parameters: ALT> 2 times upper limit of normal,"}
• {"criterion_text":"- Leukopenia (<4000 / mm3), granulocytopenia (<1500 / mm3) or lymphopenia (<1000 / mm3) from any cause."}
• {"criterion_text":"- Severe agitation."}
• {"criterion_text":"- Mental retardation."}
• {"criterion_text":"- Delirium diagnosed according to DSM-5 criteria."}
• {"criterion_text":"- Diagnosis of neurological and neurodegenerative diseases other than Alzheimer's disease (multiple sclerosis, Parkinson's disease, Huntington's disease, previous stroke)."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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) ."}
• {"criterion_text":"- Use of benzodiazepines or barbiturates one week prior to screening."}
• {"criterion_text":"- Pharmacological immunosuppression."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- Patients with any medical condition that the investigator considers to be an exclusion criterion."}
• {"criterion_text":"- Treatment with thyroid hormones started, stopped or modified within the 3 months prior to the selection visit."}
• {"criterion_text":"- Treatment of menopause with hormone replacement therapy, started, stopped or modified within the 3 months prior to the screening visit."}
• {"criterion_text":"- Use of drugs not allowed in the study (each time to be decided by the investigator): immunosuppressive anticancer agents, immunosuppressants, ethyl ester corticosteroids applied orally or topically and live attenuated vaccines. Inactivated vaccines can be used."}

Primary endpoints

• {"endpoint_text":"- Change in cognitive performance as assessed by RBANS scores between the post-treatment visit (V9) and the randomisation visit (V1).","definition_or_measurement_approach":"Change in RBANS (Repeatable Battery for the Assessment of Neuropsychological Status) total/scale scores measured between randomisation visit (V1) and post-treatment visit (V9)."}

Secondary endpoints

• {"endpoint_text":"- Assessment of the daily functioning of patients based on the ADCS-ADL scale","definition_or_measurement_approach":"Change in ADCS-ADL (Alzheimer's Disease Cooperative Study - Activities of Daily Living) scale scores."}
• {"endpoint_text":"- Assessment of the presence of neuropsychiatric symptoms / behavioral disorders in patients using the NPI, GDS scale),","definition_or_measurement_approach":"Change in Neuropsychiatric Inventory (NPI) and Geriatric Depression Scale (GDS) scores."}
• {"endpoint_text":"- Assessment of the quality of life of patients and their caregivers based on the EQ-5D scales, Zarit Burden Interview,","definition_or_measurement_approach":"Change in EQ-5D scores for patients and Zarit Burden Interview scores for caregivers."}
• {"endpoint_text":"- Assessment of the expression of peripheral markers of oxidative stress and pro-inflammatory markers.","definition_or_measurement_approach":"Measurement of specified peripheral biomarkers of oxidative stress and pro-inflammatory markers (laboratory assays as per protocol)."}
• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Change in MMSE (Mini-Mental State Examination) and CDR (Clinical Dementia Rating) scores post-therapy versus placebo."}
• {"endpoint_text":"- Difference in frequency and severity of reported adverse events in the active group versus the placebo group.","definition_or_measurement_approach":"Comparison of adverse event incidence and severity between treatment arms based on reported AEs/Safety assessments."}

Poland

Earliest CTIS Part Ii Submission Date

30-10-2024

Latest Decision Or Authorization Date

05-11-2024

Processing Time Days

6

Number Of Sites

3

Number Of Participants

100

Primary sponsor

Full Name

Medical University Of Lodz

Organisation Type

Educational Institution

Country Of Registered Address

Poland

Third parties

• {"country":"Poland","full_name":"Cefea Sp. z o.o. sp.k.","duties_or_roles":"1. repackaging of IMPs 2. storage of IMPs 3. labelling of IMPs 4. release of IMPs for clinical trial 5. Transport of IMPs 6. Disposal of IMPs","organisation_type":"Pharmaceutical company"}