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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2022-002171-11
    Sponsor's Protocol Code Number:010622
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-10-05
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2022-002171-11
    A.3Full title of the trial
    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
    Randomizowane, podwójnie zaślepione, kontrolowane placebo badanie oceniające skuteczność i bezpieczeństwo fumaranu dimetylu w redukcji atrofii mózgu, poprawie synaptycznych połączeń czynnościowych, funkcji poznawczych oraz funkcjonowania i jakości życia pacjentów z rozpoznaniem łagodnych zaburzeń poznawczych i otępienia w chorobie Alzheimera
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and efficacy of dimethyl fumarate in tratment of dementia due to Alzheimer's Disease
    Skuteczność i bezpieczeństwo fumaranu dimetylu w leczeniu otępienia w chorobie Alzheimera
    A.3.2Name or abbreviated title of the trial where available
    Safety and efficacy of dimethyl fumarate in tratment of dementia due to Alzheimer's Disease
    Skuteczność i bezpieczeństwo fumaranu dimetylu w leczeniu otępienia w chorobie Alzheimera
    A.4.1Sponsor's protocol code number010622
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMedical University of Łódź
    B.1.3.4CountryPoland
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMedical Research Agency
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University of Łódź
    B.5.2Functional name of contact pointClinical Trial Support Unit
    B.5.3 Address:
    B.5.3.1Street AddressPomorska 251, build A-2, floor II
    B.5.3.2Town/ cityŁódź
    B.5.3.3Post code92-213
    B.5.3.4CountryPoland
    B.5.4Telephone number0048422725365
    B.5.6E-mailmagdalena.lukaszuk-szkup@umed.lodz.pl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namedimethyl fumarate
    D.3.4Pharmaceutical form Gastro-resistant capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdimethyl fumarate
    D.3.9.1CAS number 624-49-7
    D.3.9.3Other descriptive nameDIMETHYL FUMARATE
    D.3.9.4EV Substance CodeSUB13608MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number240 to 240
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboGastro-resistant capsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    dementia and mild cognitice impairment due to Alzheimer's Disease
    demencja i łagodne zaburzenia poznawcze w Chorobie Alzheimera
    E.1.1.1Medical condition in easily understood language
    dementia and mild cognitice impairment due to Alzheimer's Disease
    demencja i łagodne zaburzenia poznawcze w Chorobie Alzheimera
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behaviours [F01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    ocena stopnia poprawy funkcji poznawczych, w tym pamięci, uwagi, myślenia, funkcji wykonawczych i językowych u pacjentów z rozpoznaniem MCI i AD przyjmujących fumaran dimetylu w dawce 480 mg na dobę względem pacjentów przyjmujących placebo. Oceniana będzie zmiana w punktacji baterii testów poznawczych Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
    E.2.2Secondary objectives of the trial
    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
    1. Ocena wpływu terapii na codzienne funkcjonowanie pacjentów - ADCS-AD,
    2. Ocena wpływu terapii na obecność objawów neuropsychiatrycznych/zaburzeń zachowania u pacjentów skala NPI, skala GDS,
    3. Ocena wpływu terapii na jakość życia pacjentów i ich opiekunów (skale EQ-5D; Zarit Burden Interview),
    4. Ocena wpływu terapii na redukcję stopnia atrofii mózgu u pacjentów z grupy aktywnej względem grupy kontrolnej (badanie MRI),
    5. Ocena wpływu terapii na poprawę w zakresie połączeń funkcjonalnych ocenianych w rs-fMRI oraz rs-EEG,
    6. Ocena wpływu terapii na obwodowe markery stresu oksydacyjnego oraz markery prozapalne,
    7. Ocena stopnia zmniejszenia wskaźnika progresji MCI do otępienia po zakończeniu fazy klinicznej badania,
    8. Ocen stopnia poprawy funkcji poznawczych za pomocą skal MMSE i CDR
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Mężczyźni i kobiety w wieku 55-90 lat.
    2. Pacjenci z rozpoznaniem łagodnych zaburzeń poznawczych w chorobie Alzheimera oraz łagodnym do umiarkowanego otępienia w chorobie Alzheimera (MMSE >16) zdiagnozowanym na podstawie kryteriów NIA-AA.
    3. Wynik MMSE od 17 do 30 punktów.
    4. Wynik CDR od 0.5 do 2.
    5. Podpisanie przez pacjenta świadomej, dobrowolnej zgody na udział w badaniu.
    6. Pacjent posiada osobę bliską/opiekuna faktycznego zgadzającego się na pomoc pacjentowi w trakcie uczestnictwa w badaniu.
    7. Minimalnie 6 lat edukacji.

    1. Men and women aged 55-90.
    2. 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.
    3. MMSE score from 17 to 30 points.
    4. CDR score from 0.5 to 2.
    5. Signing by the patient of informed, voluntary consent to participate in the study.
    6. The patient has a close person / actual guardian who agrees to help the patient during the participation in the study.
    7. Minimum 6 years of education.
    E.4Principal 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 <60 ml / min / m2
    2. Abnormal results of hepatic parameters: ALT> 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.
    1. Brak świadomej dobrowolnej zgody na udział w badaniu.
    2. Pacjenci nieumiejący czytać lub pisać.
    3. Kobiety w ciąży, karmiące lub w wieku rozrodczym niestosujące skutecznej antykoncepcji (antykoncepcja hormonalna, chirurgiczna sterylizacja, wkładka wewnątrzmaciczna, prezerwatywa w połączeniu z dopochwowym środkiem plemnikobójczym).
    4. Uczestnictwo w innym badaniu klinicznym, aktualnie lub w okresie 3 miesięcy przed wizytą screeningową.
    5. Niewydolność wątroby (tj. marskość lub aktywna choroba wątroby), rozpoznane ostre lub przewlekłe zapalenie wątroby niezależnie od przyczyny.
    6. Przewlekła choroba nerek z GFR poniżej < 60 ml/min/m2
    2. Nieprawidłowe wyniki parametrów wątrobowych: ALAT przekraczający > 2 razy górną granicę normy,
    3. Leukopenia (<4000/mm3), granulocytopenia (<1500/mm3) lub limfopenia (<1000/mm3) niezależnie od przyczyny.
    4. Ciężkie pobudzenie.
    5. Upośledzenie umysłowe.
    6. Majaczenie rozpoznane wg kryteriów DSM-5.
    7. Rozpoznanie innych niż choroba Alzheimera chorób neurologicznych i neurozwyrodnieniowych (stwardnienie rozsiane, choroba Parkinsona, choroba Huntingtona, przebyty udar).
    8. Obecność ognisk krwotocznych w rezonansie magnetycznym o średnicy ≥ 2 cm3, więcej niż trzy (3) udarowe ogniska niedokrwienne o średnicy ≥ 1.5 cm3 lub pojedyncze ognisko niedokrwienne o średnicy ≥ 2 cm3, obecność malformacji naczyniowych, tętniaków, krwiaka podtwardówkowego, wodogłowia normotensyjnego, ostateczna decyzja w gestii badacza.
    9. Ciężka lub niekontrolowana choroba somatyczna, która mogłaby mieć wpływ na przebieg badania (np. nowotworowa, sercowo-naczyniowa, układu oddechowego, metaboliczna lub pokarmowa, ciężka niewydolność nerek, nieustabilizowana cukrzyca typu I lub II, nieleczone lub niekontrolowane klinicznie istotne nadciśnienie tętnicze).
    10. Stosowanie benzodiazepin lub barbituranów na tydzień przed badaniem przesiewowym.
    11. Farmakologiczna immunosupresja.
    12. Pacjenci z zaburzeniem dwubiegunowym lub zaburzeniami psychotycznymi lub jakimkolwiek innym stanem psychiatrycznym (obecnym lub w przeszłości), który Badacz uważa za zakłócający badanie.
    13. Alkoholizm lub uzależnienie od narkotyków zdefiniowane przez DSM-5 w ciągu ostatnich 5 lat (uzależniony od ponad roku i lub w remisji poniżej 3 lat).
    14. Pacjenci z jakimkolwiek stanem medycznym, które w ocenie badacza stanowi kryterium wyłączające z badania.
    15. Leczenie hormonami tarczycy rozpoczęte, zakończone lub zmodyfikowane w okresie 3 miesięcy przed wizytą selekcyjną.
    16. Leczenie menopauzy hormonalną terapią zastępczą rozpoczęte, zakończone lub zmodyfikowane w okresie 3 miesięcy przed wizytą selekcyjną.
    17. Stosowanie leków niedozwolonych w badaniu: Leki przeciwnowotworowe (brak badań). Leki immunosupresyjne (brak badań). Kortykosteroidy (wpływ na wyniki projektu). Szczepionki żywe atenuowane (brak badań). Szczepionki inaktywowane mogą być stosowane. Benzodiazepiny (wpływ na oceniane punkty końcowe). Inne estry etylowe stosowane doustnie lub miejscowo.
    E.5 End points
    E.5.1Primary 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
    Ocena stopnia poprawy funkcji poznawczych na podstawie punktacji RBANS u pacjentów z rozpoznaniem MCI i AD po zakończeniu terapii fumaranem dimetylu grupy badanej względem grupy placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Last visit (up to 3 months after last dose of IMP)
    ostatnia wizyta pacjenta w badaniu (do 3 miesięcy po ostatniej dawce IMP)
    E.5.2Secondary 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.
    1. Ocena bezpieczeństwa zastosowania terapii,
    2. Ocena codziennego funkcjonowania pacjentów na podstawie oceny w skali ADCS-ADL,
    3. Ocena obecności objawów neuropsychiatrycznych/zaburzeń zachowania u pacjentów przy pomocy skali NPI, GDS),
    4. Ocena jakości życia pacjentów i ich opiekunów na podstawie skal EQ-5D, Zarit Burden Interview,
    5. Ocena ekspresji obwodowych markerów stresu oksydacyjnego oraz markerów prozapalnych,
    6. Poprawa funkcji poznawczych przy użyciu MMSE, CDR u pacjentów z rozpoznaniem MCI i AD przyjmujących fumaran dimetylu po zakończeniu terapii względem grupy placebo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Last visit (up to 3 months after last dose of IMP)
    ostatnia wizyta pacjenta w badaniu (do 3 miesięcy po ostatniej dawce IMP)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    none
    brak
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2024-07-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-07-12
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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