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    Summary
    EudraCT Number:2019-003532-23
    Sponsor's Protocol Code Number:PBD01180
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-11-21
    Trial results View 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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2019-003532-23
    A.3Full title of the trial
    A Phase 2b Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel Group Dose Finding, Safety, Tolerability and Efficacy Study of PQ912 in Subjects with Mild Cognitive Impairment and Mild Dementia due to Alzheimer’s Disease.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety, tolerability and efficacy of PQ912 in people with mild Alzheimer's disease.
    A.3.2Name or abbreviated title of the trial where available
    VIVIAD study
    A.4.1Sponsor's protocol code numberPBD01180
    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 SponsorVivoryon Therapeutics N.V.
    B.1.3.4CountryGermany
    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 supportVivoryon Therapeutics N.V.
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVivoryon Therapeutics N.V.
    B.5.2Functional name of contact pointCBO
    B.5.3 Address:
    B.5.3.1Street AddressWeinbergweg 22
    B.5.3.2Town/ cityHalle (Saale)
    B.5.3.3Post code06120
    B.5.3.4CountryGermany
    B.5.4Telephone number+49345 5559900
    B.5.5Fax number+493455559901
    B.5.6E-mailinfo@vivoryon.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 namePQ912
    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 INNVaroglutamstat
    D.3.9.2Current sponsor codePQ912
    D.3.9.3Other descriptive namePQ912
    D.3.9.4EV Substance CodeSUB120856
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 150
    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 and Mild Dementia due to Alzheimer’s Disease
    E.1.1.1Medical condition in easily understood language
    Mild Cognitive Impairment and Mild Dementia due to 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 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To assess the safety and tolerability of PQ912
    • To evaluate the efficacy of PQ912 on working memory and attention
    E.2.2Secondary objectives of the trial
    • To assess the safety and tolerability of long-term PQ912
    • To evaluate the efficacy of PQ912 on brain activity (EEG)
    • To evaluate the efficacy of PQ912 on cognition
    • To evaluate the efficacy of PQ912 on activities of daily living
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed and dated written informed consent obtained from the subject in accordance with local regulations.
    2. Male or female, aged ≥ 50 to ≤ 80 years
    3. A biomarker profile reflecting AD, according to the Alzheimer Association – National Institute on Aging (AA-NIA) Research Framework (Jenkins, Hardy, and McMurray 2002) (Jack et al. 2018) defined as follows:
    c) Screening CSF sample with an Aβ42 concentration of <1000 pg/ml AND p-tau >19 pg/ml, or a ratio of p-tau/Aβ42 of ≥0.024 as assessed by central laboratory, (Elecsys assay), OR, in case of subjects in whom CSF sampling is not feasible due to medical or technical reasons.
    d) Existing Positive amyloid Positron-Emission Tomography (PET) evidence within six months of the screening visit.
    4. Clinical syndrome of MCI or mild dementia according to the AA-NIA Research Framework (Jack et al. 2018)
    5. A cognitive impairment in the WAIS-IV Coding Test of at least 0.5 standard deviations below the normative data. The cut-off score is inclusive, meaning that subjects scoring on or
    below the required score meet the criterion.
    6. Meeting the completion and performance criteria for the CogState NTB.
    7. Be in a stable therapeutic condition with respect to the current AD condition: either without specific current approved treatment (minimum wash-out period from a prior treatment is 10 weeks) and currently no plan to initiate currently approved treatment or being on an approved treatment for AD on a stable dose for at least 10 weeks.
    8. Fluency in local language and evidence of adequate intellectual functioning in the opinion of the investigator.
    9. Adequate visual and auditory abilities to perform the cognitive and functional assessments in the opinion of the investigator.
    10. Outpatient with study partner capable of accompanying the subject on all applicable clinic visits.
    11. The subject and study partner are likely to be able to participate in all scheduled evaluations according to country and site practices.
    E.4Principal exclusion criteria
    1. Significant neurological or psychiatric disorders, other than AD, that may affect cognition.
    2. Atypical clinical presentations of MCI due to AD or mild dementia due to AD, such as visual variant of AD (including posterior cortical atrophy), frontal variant or language variant (including logopenic aphasia).
    3. Moderate and severe dementia with Mini-Mental State Examination score (MMSE) below 20.
    4. History of (maximally six months from screening) or screening visit brain MRI scan indicative of any other significant abnormality, including but not limited to severe white matter hyperintensities (Fazekas score 3), history or evidence of a single prior haemorrhage >1 cm3, multiple lacunar infarcts or evidence of single prior infarct >1 cm3, evidence of cerebral contusion, encephalomalacia, aneurysms, vascular malformations, subdural hematoma, or space-occupying lesions (e.g. brain tumours).
    5. Current presence of clinically important major psychiatric disorder (e.g. major depressive disorder) as defined by DSM-5 criteria, or symptom(s) (e.g. hallucinations) that could affect subject’s ability to complete study.
    6. Current clinically important systemic illness likely to result in clinically relevant deterioration of subject’s condition or might affect subject’s safety during study.
    7. History of clinically evident stroke.
    8. History of seizures within last two years prior to screening visit.
    9. Myocardial infarction within last six months prior to screening.
    10. History of cancer within last two years prior to screening, with exception of any of following conditions: non-metastatic basal cell carcinoma, and squamous cell carcinoma of skin. Note: subjects can be included in study with prior history of cancer if evidence of no residual disease has been clinically confirmed within last six months before baseline.
    11. History of uncontrolled hypertension (opinion of investigator) within six months prior to screening.
    12. Other clinically important diseases or conditions or abnormalities of vital signs, physical examination, neurological examination, laboratory results, or electrocardiogram (ECG) examination (e.g. atrial fibrillation) that could compromise study or safety of subject.
    13. Haemoglobin level less than 11 g/dL (6.8 mmol/L) at screening.
    14. Clinically important infection within 30 days prior to screening e.g. chronic, persistent, or acute infection, such as bronchitis or urinary tract infection.
    15. Known, untreated or insufficiently treated hypothyroidism, vitamin B12 or folate deficiency.
    16. Any known hypersensitivity to investigational product PQ912 or any of excipients.
    17. Severe hepatic failure (Child-Pugh C) or kidney failure (creatinine clearance (eGFR) ≤ 30 mL/min/1.73m2) as estimated using MDRD method, or serum creatinine above 1.5-fold of Upper Limit of Normal (ULN) or Asparagine-Amino Transferase (AST) or Alanine-Amino Transferase (ALT) above 3 fold of ULN at screening.
    18. Blood donation in 90 days prior to screening.
    19. History of alcohol or drug dependence or abuse as defined by DSM-5 criteria within last two years prior to screening.
    20. Claustrophobia or presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, CSF shunts, or metal fragments or foreign objects in eyes, skin, or body that would contraindicate a brain MRI scan.
    21. Inadequate venous access to allow multiple blood draws.
    22. Personnel involved in conduct of the study.
    23. Previous participation in any investigational trial within last 60 days of screening visit (see section 7.6).
    24. Use of prohibited medications or of measures/ interventions (see 7.6)
    o Immunosuppressive medications within last 90 days prior to baseline
    o Chemotherapeutic agents for malignancy within last year prior to baseline
    o Concomitant treatment which may impair cognitive function requires a wash out phase of at least 5 half-lives of treatment prior screening (short acting hypnotics are not permitted 72 hours before EEG or cognitive testing).
    o Anticoagulants within 30 days prior to screening and V8 (week 48)/ EOT. Combination of clopidogrel & carbasalate calcium or aspirin not allowed during time of lumbar puncture. Clopidogrel or aspirin alone is allowed.
    Strong inhibitors or inducers of CYP2C19 (washout phase of at least two weeks before baseline).
    o Substrates of CYP2C19 with narrow therapeutic margin (washout phase of at least two weeks before baseline).
    o St. John’s Wort (washout phase of at least 2 weeks prior to baseline is required).
    25. For women of childbearing potential:
    (a) Pregnancy (i.e. positive pregnancy test at Screening) or breastfeeding
    (b) Failure to agree to practice a highly effective method of contraception (see Section 7.8.1), from enrolment up to at least 3 months after the study end.
    26. For sexually active men with female partner of childbearing potential: Failure to agree to use condom (see Section 7.8.2) from enrolment up to at least 3 months after study end.
    E.5 End points
    E.5.1Primary end point(s)
    • all spontaneously reported AEs, vital signs (heart rate and blood pressure), clinical laboratory tests, physical and neurological examinations.
    • ECG measurements and changes on brain MRI scans as judged by the investigational site rater (Amyloid-related Imaging Abnormalities – Edema/Effusion [ARIA-E], Amyloid-related Imaging Abnormalities – Haemorrhage/Haemosiderin deposition [ARIA-H], infarcts).
    • Change with time on working memory and attention as measured by the combined Z-score of the Detection test, Identification test and the ‘One Back’ test (attention and working memory domains) of the NTB.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of Treatment visit (week 48, 60, 72, 84 or 96 weeks of treatment, depending on time of randomization.)
    E.5.2Secondary end point(s)
    • Change from baseline in global relative theta power in the EEG (4-8 Hz) at week 48
    • Change with time in overall cognition as measured by the CBB Z-score
    • Change with time of overall cognition as measured by the composite Z-score of the complete NTB
    • Change from baseline in daily activities as measured by A-IADL-Q total score at EOT
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 48 and End of Treament (i.e. week 60, 72, 84 or 96 weeks of treatment, depending on time of randomization.)
    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 No
    E.6.7Pharmacodynamic Yes
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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 years
    E.8.9.1In the Member State concerned months43
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months43
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 224
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 259
    F.4.2.2In the whole clinical trial 259
    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)
    Standard of care treatment
    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 Decision2020-04-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-01-12
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