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    Summary
    EudraCT Number:2018-003567-66
    Sponsor's Protocol Code Number:T817MAEU201
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2018-12-24
    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 ConcernedUK - MHRA
    A.2EudraCT number2018-003567-66
    A.3Full title of the trial
    A Phase 2 multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of T 817MA in patients with mild cognitive impairment due to Alzheimer’s Disease or mild Alzheimer’s Disease.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the efficacy and safety of T 817MA in patients with mild cognitive impairment due to Alzheimer’s Disease or mild Alzheimer’s Disease.Patients to be randomly allocated to either placebo or investigational drug; assignment will be unknown to patients and doctor.
    A.4.1Sponsor's protocol code numberT817MAEU201
    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 SponsorFUJIFILM Toyama Chemical Co., Ltd.
    B.1.3.4CountryJapan
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFUJIFILM Toyama Chemical Co., Ltd.
    B.4.2CountryJapan
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJulius Clinical
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressBroederplein 41-43
    B.5.3.2Town/ cityZeist
    B.5.3.3Post code3703 CD
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031306569900
    B.5.6E-mailregulatory@juliusclinical.com
    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 No
    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 nameT817MA
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNEdonerpic
    D.3.9.1CAS number 519187-97-4
    D.3.9.3Other descriptive nameT-817MA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number224 to 448
    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 placeboFilm-coated tablet
    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
    Mild cognitive impairment due to Alzheimer's Disease or mild Alzheimer's Disease.
    E.1.1.1Medical condition in easily understood language
    Mental disabilities due to Alzheimer's Disease or mild Alzheimer's Disease.
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 100000004852
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10009846
    E.1.2Term Cognitive impairment
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the neuroprotective effect of T-817MA on Tau protein phosphorylated at threonine 181 (p-tau181) in CSF compared with placebo, in patients with a diagnosis of MCI due to AD or mild AD, according to the National Institute on Aging - Alzheimer Association (NIA-AA) criteria, with a Mini Mental Status Examination (MMSE) score of 24 to 30 (inclusive), and Aß1-42 and p-tau181 abnormality in CSF (≤1000 pg/ml for Aß1-42, ≥19 pg/ml for p-tau181) or (p-tau181/Aβ1-42 ratio >0.020 for patients with p-tau181 ≥19 pg/ml and 1000<Aβ1-42<1700 pg/ml).
    E.2.2Secondary objectives of the trial
    To evaluate in patients on T-817MA and placebo:
    • cognitive function measured by the Clinical Dementia Rating Scale Sum of Boxes (CDR-sb) and Cognitive Functional Composite (CFC)
    • AD-related biomarkers in CSF (Tau protein phosphorylated at threonine 217 (p-tau217), total tau, Aβ1-40, Aβ1-42, neurofilament light (NFL), neurogranin, YKL-40 and Aβ1-42/Aβ1-40 ratio) and in plasma (Aβ1-40, Aβ1-42 and NFL)
    • imaging analysis using volumetric magnetic resonance imaging (vMRI)
    • alpha/theta ratio of the electroencephalogram (EEG)
    To evaluate the safety of T 817MA by clinical laboratory tests and AEs
    To evaluate the pharmacokinetics of T 817MA in plasma and CSF.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, age 50 to 80 inclusive at date of ICF signature.
    2. Diagnosis by the investigator of a clinical syndrome of cognitive impairment consistent with either MCI due to AD or mild AD per NIA-AA diagnostic criteria (Jack et al., 2018), with MMSE 24 to 30 (inclusive).
    3. CSF results at screening consistent with the presence of Aß1-42 and p-tau181 abnormality (≤1000 pg/ml for Aß1-42, ≥19 pg/ml for p-tau181) or (p-tau181/Aβ1-42 ratio >0.020 for patients with p-tau181 ≥19 pg/ml and 1000<Aβ1-42<1700 pg/ml).
    4. A brain MRI not-inconsistent with the clinical diagnosis of MCI due to AD or mild AD
    5. Receiving an AChE inhibitor (donepezil, galantamine or rivastigmine) at a stable dose for more than 3 months prior to randomization, or not receiving any AChE inhibitors.
    6. Weight of ≤100 kg (220 pounds) at Screening
    7. Ability (patients and their study partners) to read, speak and understand local language to ensure compliance with cognitive testing and study visit procedures
    8. Living in the community (includes assisted living facilities, but excludes long-term care nursing facilities)
    9. Ambulatory, or able to walk with an assistive device, such as a cane or walker
    10. If male, patients must: a. agree he will not donate sperm during the study and until 104 days after the last dose, AND b. be required to use the following highly effective methods of contraception during the study and until 104 days after the last dose:
    i. Abstain from sexual intercourse OR
    ii. Use a condom during sexual intercourse with pregnant or non-pregnant women of childbearing potential (WOCBP) partner even if he is vasectomized.
    In addition, WOCBP partner of the male patient (except a vasectomized male) must use one of the following highly effective methods of contraception.
    • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: - oral - intravaginal - transdermal
    • Progestogen-only hormonal contraception associated with inhibition of ovulation: - oral - injectable - implantable
    • Intrauterine device (IUD)
    • Intrauterine hormone-releasing system (IUS)
    • Bilateral tubal occlusion
    11. If female, patients must: a. be post-menopausal (i.e. no menses for 12 months without an alternative medical cause) OR b. be permanently sterilized with methods including hysterectomy, bilateral salpingectomy and bilateral oophorectomy
    12. A study partner who has regular contact with the patient for at least 10 hours per week and is able to participate in the patient’s clinical assessment and complete the questionnaire about the patient’s daily life at Screening, Baseline and Weeks 28, 52 and 78
    13. Patient is clearly able to understand the nature, meaning and consequences of the clinical trial and its interventions and conveys his/her will to participate by personally signing the informed consent form
    14. Written informed consent obtained from study partner
    E.4Principal exclusion criteria
    Patients meeting any of the following criteria must not be included in the study:
    1. Has had an MRI of the brain within the previous 2 years that showed pathology that would be inconsistent with a diagnosis of AD
    2. Use of prohibited medications, including memantine
    3. Has any contraindications for MRI including claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker that is not compatible with MRI
    4. Has any contraindications to lumbar puncture
    5. Pregnant or breastfeeding woman
    6. Psychiatric disorder such as schizophrenia or dementia not of the Alzheimer’s type according to the criteria of DSM-5
    7. Other neurodegenerative diseases, including Parkinson’s disease and Huntington’s disease, or cerebral tumor
    8. Dementia other than AD
    9. History of untreated thyroid disorder, Type I diabetes, and insulin-dependent or uncontrolled Type II diabetes, as determined by the investigator (except non-insulincontrolled Type II diabetes, whose HbA1c value must be below 8.0 %). The HbA1c value should not be older than 6 months prior to screening. If no recent HbA1c value is available, then HbA1c should be assessed locally.
    10. History of a seizure disorder andor stroke, unless >5 years ago
    11. History of alcohol abuse or dependence or drug abuse in the past 5 years
    12. Uncorrected impairment of vision or hearing that would preclude the patient from taking tests or patients lacking the ability to communicate
    13. Clinically significant abnormal laboratory values in the opinion of the investigator
    14. Severe hepatic or severe renal impairment (e.g. bilirubin > 3 x ULN, AST/ALT > 5 x ULN, eGFR < 30 ml/min/1.73m2 or CrCl <30 ml/min)
    15. Clinically significant B12 deficiency (i.e., no macrocytosis) in the opinion of the investigator
    16. Severe heart disease (history of myocardial infarction, congestive heart disease, history of unstable angina pectoris, clinically significant ECG abnormality) within 6 months prior to screening. Patients with arterial thrombosis will not be excluded if they are stable for at least 6 months prior to Screening
    17. Cancer or a malignant tumor within the past 3 years, except patients who underwent potentially curative therapy with no evidence of recurrence.
    18. Participation in another clinical trial for an investigational agent and having taken at least one dose of study medication, unless confirmed as having been on placebo, within 12 weeks prior to screening. (The end of a previous investigational trial is defined as the date of the last dose of an investigational agent.)
    19. Participation in a previous clinical trial with T 817MA
    20. Patients whom the investigator deems to be otherwise ineligible
    21. Has an MRI of the brain at screening indicative of significant abnormality, including, but not limited to, prior hemorrhage or infarct, large (>1 cm) infarct, >2 lacunar infarcts outside the brain stem, severe white matter changes (Fazekas grade 3), >4 microbleeds, superficial hemosiderosis >1 cm, aneurysm, vascular malformation, subdural hematoma, hydrocephalus, space-occupying lesion (e.g, abscess or brain tumor such as meningioma).
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the change in the CSF biomarker p-tau181 from Baseline to Week 78.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, week 52 and week 78.
    E.5.2Secondary end point(s)
    The secondary efficacy endpoints are:
    1. The change in cognitive function assessed by CDR-sb and CFC from Baseline to Weeks 28, 52 and 78.
    2. The change in the CSF biomarker p-tau181 from Baseline to Week 52.
    3. The change in the CSF biomarkers p-tau217, total tau, Aβ1-42, Aβ1-40, NFL, neurogranin, YKL-40 and Aβ1-42/Aβ1-40 ratio from Baseline to Weeks 52 and 78.
    4. The change in plasma biomarkers Aβ1-42, Aβ1-40 and NFL from Baseline to Weeks 52 and 78.
    5. The change in brain volume (total brain volume (TBV), ventricular volume and hippocampal volume) and cortical thickness measured by vMRI from Baseline to Weeks 52 and 78
    6. The change in alpha/theta ratio measured by the EEG from Baseline to Weeks 52 and 78
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, week 52 and week 78.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA39
    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 Yes
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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)
    A 4-week post-treatment observation period is included.
    After participation in the trial, the treating physician of the patient will consider appropriate treatment or care .
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-05-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-04
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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