dementia and mild cognitice impairment due to Alzheimer's Disease
Conditions
Interventions
Product Name: dimethyl fumarate
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: dimethyl fumarate
CAS Number: 624-49-7
Other descriptive name: DIMETHYL FUMARATE
Concentration
Sponsors
Medical University of Lódz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Me?z?czyz´ni i kobiety w wieku 55-90 lat. 2. Pacjenci z rozpoznaniem lagodnych zaburzen´ poznawczych w chorobie Alzheimera oraz lagodnym do umiarkowanego ote?pienia w chorobie Alzheimera (MMSE >16) zdiagnozowanym na podstawie kryterio´w NIA-AA. 3. Wynik MMSE od 17 do 30 punkto´w. 4. Wynik CDR od 0.5 do 2. 5. Podpisanie przez pacjenta swiadomej, dobrowolnej zgody na udzial w badaniu. 6. Pacjent posiada osobe bliska?/opiekuna faktycznego zgadzajacego sie? na pomoc pacjentowi w trakcie uczestnictwa w badaniu. 7. Minimalnie 6 lat edukacji. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: 1. Lack of informed consent to participate in the study. 2. Inability to read or write. 3. 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). 4. Participation in another clinical trial, currently or within 3 months before the screening visit. 5. Liver failure (ie cirrhosis or active liver disease), diagnosed acute or chronic hepatitis, regardless of the cause. 6. Chronic kidney disease with GFR 2 times upper limit of normal, 3. Leukopenia (<4000 / mm3), granulocytopenia (<1500 / mm3) or lymphopenia (<1000 / mm3) from any cause. 4. Severe agitation. 5. Mental retardation. 6. Delirium diagnosed according to DSM-5 criteria. 7. Diagnosis of neurological and neurodegenerative diseases other than Alzheimer's disease (multiple sclerosis, Parkinson's disease, Huntington's disease, previous stroke). 8. 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. 9. 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) . 10. Use of benzodiazepines or barbiturates one week prior to screening. 11. Pharmacological immunosuppression. 12. 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. 13. Alcoholism or drug addiction as defined by DSM-5 within the last 5 years (addicted for more than one year and or in remission for less than 3 years). 14. Patients with any medical condition that the investigator considers to be an exclusion criterion. 15. Treatment with thyroid hormones started, stopped or modified within the 3 months prior to the selection visit. 16. Treatment of menopause with hormone replacement therapy, started, stopped or modified within the 3 months prior to the screening visit. 17. Use of drugs not allowed in the study: Antineoplastic drugs (no studies). Immunosuppressants (no studies available). Corticosteroids (impact on project outcomes). Live attenuated vaccines (no studies). Inactivated vaccines may be used. Benzodiazepines (effect on assessed endpoints). Other ethyl esters orally or topically.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. The change in the score of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) will be assessed.;Secondary Objective: 1. Assessment of the impact of therapy on the daily functioning of patients - ADCS-ADL Scale, 2. Assessment of the effect of therapy on the presence of neuropsychiatric symptoms / behavioral disorders in patients - NPI scale, GDS scale 3. Assessment of the impact of therapy on the quality of life of patients and their caregivers (EQ-5D scales; Zarit Burden Interview), 4. Assessment of the effect of therapy on the reduction of the degree of brain atrophy in patients from the active group compared to the control group (MRI test), 5. Assessment of the impact of therapy on the improvement of functional connections assessed in rs-fMRI and in rs-EEG, 6. Assessment of the effect of therapy on peripheral markers of oxidative stress and pro-inflammatory markers, 7. Assessment of the degree of reduction in the rate of MCI progression to dementia after the end of the clinical phase of the study, 8. Assessment of the degree of improvement in cognitive functions using the MMSE and CDR scales;Primary end point(s): Assessment of the degree of improvement in cognitive functions based on the RBANS scores in patients diagnosed with MCI and AD after completing dimethyl fumarate therapy in the study group compared to the placebo group;Timepoint(s) of evaluation of this end point: Last visit (up to 3 months after last dose of IMP) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Assessment of the safety of the use of therapy, 2. Assessment of the daily functioning of patients based on the ADCS-ADL scale, 3. Assessment of the presence of neuropsychiatric symptoms / behavioral disorders in patients using the NPI, GDS scale), 4. Assessment of the quality of life of patients and their caregivers based on the EQ-5D scales, Zarit Burden Interview, 5. Assessment of the expression of peripheral markers of oxidative stress and pro-inflammatory markers, 6. 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.;Timepoint(s) of evaluation of this end point: Last visit (up to 3 months after last dose of IMP) | — |
Countries
Poland
Contacts
Public ContactClinical Trial Support Unit
Medical University of Lódz
Outcome results
None listed