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    Summary
    EudraCT Number:2016-002635-15
    Sponsor's Protocol Code Number:15-06
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-07-14
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2016-002635-15
    A.3Full title of the trial
    Study to Identify Factors associated with Resilience to Clinical Dementia at Old Age
    Studie naar de beschermende factoren voor dementie bij mensen boven de 90 jaar
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Protective factors for dementia in subjects aged 90 years and older
    Beschermende factoren voor dementie bij mensen boven de 90 jaar
    A.3.2Name or abbreviated title of the trial where available
    90+ Study
    90+ Studie
    A.4.1Sponsor's protocol code number15-06
    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 SponsorVU Medical Center
    B.1.3.4CountryNetherlands
    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 supportGE HealthCare
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportIMI (Innovative Medicine Initiative)
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVU Medical Center
    B.5.2Functional name of contact pointAlzheimer Center
    B.5.3 Address:
    B.5.3.1Street AddressDe Boelelaan 1118
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081 HZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310204448527
    B.5.6E-mailn.legdeur@vumc.nl
    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.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameFlutemetamol (18F)
    D.3.2Product code AH110690 (18F) Injection
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The protective factors of Alzheimer's disease in subjects aged 90 years and older
    De beschermende factoren tegen de ziekte van Alzheimer in mensen van 90 jaar en ouder
    E.1.1.1Medical condition in easily understood language
    Dementia in subjects aged 90 years and older
    Dementie in mensen van 90 jaar en ouder
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    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
    The main objectives are to understand how clinical markers and biomarkers previously identified in younger and older AD cohorts apply to the extreme elderly (90+ years old) and to identify novel biomarkers linked with resilience to developing Alzheimer’s disease (AD) in extreme elderly subjects. In addition we will generate normative data for the oldest and measure the concordance between amyloid pathology as assessed in CSF and by PET in the oldest old.
    Het voornaamste doel van ons onderzoek is het achterhalen van de factoren die ervoor zorgen dat sommige ouderen op hoge leeftijd (≥90 jaar) goede cognitieve functies behouden en geen dementie ontwikkelen. We zullen ons hierbij gaan richten op factoren waarvan de associatie met dementie op jongere leeftijd al is vastgesteld en op niet eerder vastgestelde factoren die wellicht beschermend kunnen zijn tegen het krijgen van dementie. Daarnaast zullen we op basis van de gegevens uit de cognitief gezonde groep deelnemers, normaalwaarden vaststellen voor zowel klinische markers (bv neuropsychologische testen) als biomarkers (bv amyloid waarden in het hersenvocht).
    E.2.2Secondary objectives of the trial
    The secundary study parameters are: 1. Generate normative data for the oldest old. 2. To measure the concordance between amyloid pathology as assessed in CSF and by PET in the oldest old.
    De secundaire onderzoeksvariabelen zijn: 1. De gegevens van de cognitief gezonde groep zal gebruikt worden voor het vaststellen van normaalwaarden van verschillende markers bij mensen van 90 jaar en ouder. 2. Tevens zal gekeken worden naar de concordantie tussen amyloid pathologie gemeten met behulp van een PET-MRI scan en gemeten in het hersenvocht bij mensen ouder dan 90 jaar.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age ≥ 90 years Candidate is able to walk 400 meter independently (with or without walking aid) No significant visual or hearing impairment (as judged by clinician) Cognitively intact group: - MMSE ≥ 27 points - Clinical Dementia Rating (CDR) = 0.0 points Cognitive impaired group: - MMSE: 20-28 points inclusively - CDR ≥ 1 point(s) - Determination that this dysfunction is due to cognitive functional loss and not physical impairment, as judged by a neurologist or internist-geriatrician. There is an overlap in MMSE score but this has no effect on the contrast between the two groups. The two groups are based on dementia diagnosis and the MMSE score has no influence on this diagnosis. Someone with a MMSE of 27 can be both dement or cognitively healthy.
    Leeftijd ≥ 90 jaar Kandidaat is in staat 400 meter zelfstandig te lopen (met of zonder hulpmiddel) Geen significante visus of gehoor beperking (beoordeeld door clinicus) Cognitief gezonde groep: - MMSE ≥ 27 punten - Clinical Dementia Rating (CDR) = 0.0 punten
    Cognitieve stoornissen groep: - MMSE: 20 t/m 28 punten - CDR: ≥ 1 punt(en) - Door neuroloog of internist-geriater vastgesteld dat de dysfunctie het gevolg is van het cognitieve functieverlies en niet door fysieke beperkingen. Er bestaat een overlap in MMSE maar dit heeft geen gevolg voor het contrast tussen de 2 groepen. De diagnose dementie wordt namelijk niet gesteld op basis van de MMSE. Iemand met een MMSE van 27 kan zowel dement zijn als cognitief gezond.
    E.4Principal exclusion criteria
    Clinical diagnosis of severe AD Severe head trauma, with loss of consciousness Brain tumour (past, present) Schizophrenia, bipolar disorder, or recurrent psychotic disorders Stroke resulting in physical impairment Non-AD neurodegenerative disorders (e.g. Huntington disease, cortical basal degeneration, multiple system atrophy, Creutzfeldt­Jacob disease, primary progressive aphasia, Parkinson’s disease, diffuse Lewy body disease, frontotemporal dementia, primary vascular dementia) Epilepsy, currently using antiepileptic drugs (AEDs) Brain infections (e.g. herpes simplex encephalitis) Cancer with terminal life expectancy (life expectancy <12 months) Cancer chemotherapy or radiotherapy within the last 3 months Known B12 vitamin deficiency without treatment Uncontrolled diabetes mellitus (last measure HbA1c >80 mmol/mol) Known thyroid disease without treatment History of recreational drug use Alcohol consumption: >35 units per week (1 unit = 10ml of pure alcohol) Physical morbidity or illness which will not permit attendance at visit sessions Contraindication for MRI (e.g. metal implants, pacemaker etc.) Medications that may impair cognition, at the discretion of the investigator, e.g.: - Benzodiazepine with known effects on cognitive functioning - Lithium carbonate - Antipsychotics including atypical agents - Antidepressants with known effects on cognitive functioning - Parkinson’s disease medicines
    Klinische diagnose ernstige AD Ernstig hoofdtrauma met bewustzijnsverlies Hersentumor (in het verleden of heden) Schizofrenie, bipolaire stoornis, recidiverende psychotische stoornissen CVA (cerebrovasculair accident) resulterend in fysieke beperkingen Neurodegeneratieve aandoeningen niet veroorzaakt door AD Epilepsie waarvoor anti-epiletica worden gebruikt Herseninfectie (bv herpes simplex encefalitis) Maligniteit met een terminale levensverwachting van minder dan 12 maanden Chemo- of radiotherapie in verband met een maligniteit in de afgelopen 3 maanden Bekende vitamine B12 deficiëntie zonder therapie Ongecontroleerde diabetes mellitus (laatste meting HbA1c >80 mmol/mol) Bekende schildklieraandoening zonder behandeling Recreatief drugsgebruik Alcohol consumptie: >35 eenheden per week Fysieke morbiditeit waardoor iemand niet in staat is naar het ziekenhuis te komen Contraindicatie voor MRI (bv pacemaker) Medicatie die van invloed kan zijn op de cognitie, beoordeeld door onderzoeker, bv: - benzodiazepine - lithium - antipsychotica - antidepressiva - Parkinson medicatie
    E.5 End points
    E.5.1Primary end point(s)
    The primary study parameters are: 1. To understand how clinical markers and biomarkers previously identified (and published) in younger and older dementia cohorts apply to the extreme elderly. 2. To identify novel biomarkers linked with resilience to developing AD in extreme elderly subjects. The clinical markers and biomarkers we will test, can be divided into the following 6 domains: - brain reserve capacity - comorbidity - genetics - physical performance - senescence state - biomarkers for AD For each domain we will test one or more parameters. For each parameter we will study whether this parameter is associated with resilience for dementia in the oldest old.
    De primaire onderzoeksvariabelen zijn: 1. onderzoeken of klinische markers en biomarkers die eerder in een jonger AD cohort zijn vastgesteld, ook gelden voor een populatie van 90 jaar en ouder 2. het identificeren van nieuwe biomarkers die wellicht gelinkd zijn aan bescherming tegen het krijgen van AD op zeer hoge leeftijd. De verschillende klinische markers en biomarkers die worden onderzocht, kunnen worden onderverdeeld in 6 domeinen: - hersen reserve capaciteit - comorbiditeit - genetica - fysieke activiteit - senescence status - biomarkers voor AD Binnen elk domein worden één of meer parameters gemeten. Voor alle parameters zal onderzocht worden of of deze geassocieerd is met bescherming tegen dementie op hoge leeftijd.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation of these end points will be done after the last visit.
    Evaluatie van de eindpunten zal na de laatste visite gedaan worden.
    E.5.2Secondary end point(s)
    The secundary study parameters are: 1. Generate normative data for the oldest old. 2. To measure the concordance between amyloid pathology as assessed in CSF and by PET in the oldest old.
    De secundaire onderzoeksvariabelen zijn: 1. De gegevens van de cognitief gezonde groep zal gebruikt worden voor het vaststellen van normaalwaarden van verschillende markers bij mensen van 90 jaar en ouder. 2. Tevens zal gekeken worden naar de concordantie tussen amyloid pathologie gemeten met behulp van een PET-MRI scan en gemeten in het hersenvocht bij mensen ouder dan 90 jaar.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation of these end points will be done after the last visit.
    Evaluatie van de eindpunten zal na de laatste visite gedaan worden.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    observatieve studie
    observation study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state114
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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
    Geen
    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 Decision2016-07-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-10-02
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