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    Summary
    EudraCT Number:2018-000342-19
    Sponsor's Protocol Code Number:IIT-2017/02
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-08-20
    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 ConcernedGermany - BfArM
    A.2EudraCT number2018-000342-19
    A.3Full title of the trial
    Prospective, randomized, double-blind clinical trial phase II for the anti-inflammatory effects of Curazink (zinc histidine) for 8 weeks in elderly patients with mild cognitive impairment in Alzheimer's disease or in patients with mild Alzheimer's disease
    Prospektive, randomisierte, doppelblinde Klinische Prüfung nach Phase II zur entzündungshemmenden Wirkung einer 8-wöchigen Gabe von Curazink (Zink-Histidin) bei älteren Patienten mit einer leichten kognitiven Störung bei Alzheimer-Erkrankung oder Patienten mit leichter Alzheimer-Demenz
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    clinical trial or the anti-inflammatory effects of Curazink for 8 weeks in elderly patients with mild cognitive impairment in Alzheimer's disease or in patients with mild Alzheimer's disease
    Klinische Prüfung zur entzündungshemmenden Wirkung einer 8-wöchigen Gabe von Curazink bei älteren Patienten mit einer leichten kognitiven Störung bei Alzheimer-Erkrankung oder Patienten mit leichter Alzheimer-Demenz
    A.3.2Name or abbreviated title of the trial where available
    DEZINK
    DEZINK
    A.4.1Sponsor's protocol code numberIIT-2017/02
    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 SponsorOtto-von-Guericke-Universität Magdeburg, Medizinische Fakultät
    B.1.3.4CountryGermany
    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 supportEFRE IB Land Sachsen-Anhalt
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKKS Magdeburg, Med. Fakultät, OvGU Magdeburg
    B.5.2Functional name of contact pointDr. rer. nat. Antje Wiede
    B.5.3 Address:
    B.5.3.1Street AddressLeipziger Str. 44
    B.5.3.2Town/ cityMagdeburg
    B.5.3.3Post code39120
    B.5.3.4CountryGermany
    B.5.4Telephone number+493916715307
    B.5.5Fax number+493916715898
    B.5.6E-mailantje.wiede@med.ovgu.de
    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.2.1.1.1Trade name Curazink
    D.2.1.1.2Name of the Marketing Authorisation holderStada
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameCurazink
    D.3.4Pharmaceutical form 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.3.9.1CAS number 7440-66-6
    D.3.9.2Current sponsor codeIIT-2017/02
    D.3.9.3Other descriptive nameZINC
    D.3.9.4EV Substance CodeSUB12619MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number15
    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.3.11.13.1Other medicinal product typeantiinflammatory, immunomodulatory
    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 placeboCapsule, 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
    Included are patients with the presence of a moderate or pronounced zinc deficienc and the diagnosis of a mild cognitive disorder, which may be due to an additional investigation (amyloid PET and / or cerebrospinal fluid) in the context of already performed diagnostic clarification an Alzheimer's pathology.
    Eingeschlossen werden Patienten bei Vorliegen eines moderaten oder ausgeprägten Zinkmangels und mit der Diagnose einer leichten kognitiven Störung, die durch eine Zusatzuntersuchung im Rahmen der bereits erfolgten diagnostischen Abklärung eine Alzheimerpathologie zu vermuten ist.



    E.1.1.1Medical condition in easily understood language
    Patients have mild cognitive impairment or mild dementia of the Alzheimer type.

    Bei den Patienten liegt eine leichte kognitive Störung bzw. eine leichtgradige Demenz vom Alzheimertyp vor.






    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 first primary goal is to demonstrate the anti-inflammatory effect of Curazink based on the concentration of the C-reactive protein (CRP, acute phase protein). Under the 8-week treatment with Curazink (zinc histidine), a significant decrease in CRP plasma concentrations compared to placebo is expected. A second primary goal is to study the effect of Curazink on cognitive behavior (using Alzheimer's Disease Assessment Scale-Cognitive Subscale Test).
    Erstes primäres Ziel ist der Nachweis der entzündungshemmenden Wirkung von Curazink anhand der Konzentration des C-reaktiven Proteins (CRP, Akute-Phase-Protein). Unter der 8-wöchigen Therapie mit Curazink (Zink-Histidin) wird eine signifikante Abnahme der CRP-Plasma-Konzentrationen im Vergleich zur Verabreichung von Placebo erwartet. Ein zweites primäres Ziel besteht in der Untersuchung der Wirkung von Curazink auf das kognitive Verhalten (mittels Alzheimer’s Disease Assessment Scale-Cognitive Subscale test).
    E.2.2Secondary objectives of the trial
    Secondary objectives include studies on effects on immunological laboratory parameters, cognitive deficits and health-related quality of life.
    Sekundäre Ziele sind Untersuchungen zu Auswirkungen auf immunologische Laborparameter, kognitive Defizite und die gesundheitsbezogene Lebensqualität.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Included are patients:
    - aged> 55 years
    - in the presence of a zinc deficiency or serum zinc concentrations in the lower normal range (zinc in the serum = <13 μmol / l, reference range: 9 - 18 μmol / l);
    - in the diagnosis of a mild cognitive disorder, which may be due to an additional investigation (amyloid PET and / or cerebrospinal fluid) in the context of already performed diagnostic clarification an Alzheimer's pathology (NIA-AA criteria [1]).
    - Patients with mild Alzheimer's dementia (MMST>= 18) according to NIA-AA criteria [2].
    - Patients who understand the goals of the study and the potential side effects.
    - who are able to consent and sign the declaration of consent
    - who are sufficiently powerful in the German language to carry out the neuropsychological testing.
    Eingeschlossen werden Patienten:
    - im Alter von >55 Jahren
    - bei Vorliegen eines Zinkmangels oder von Serum-Zinkkonzentrationen im unteren Normbereich (Zink im Serum = < 13 µmol/l; Referenzbereich: 9 - 18 µmol/l);
    - bei Diagnose einer leichten kognitiven Störung, die durch eine Zusatzuntersuchung (Amyloid-PET und/oder Liquor) im Rahmen der bereits erfolgten diagnostischen Abklärung eine Alzheimerpathologie zu vermuten ist (NIA-AA Kriterien [1]).
    - Patienten mit einer leichten Alzheimer-Demenz (MMST >= 18) nach NIA-AA Kriterien [2].
    - Patienten die die Ziele der Studie und die potentiellen Nebenwirkungen verstehen.
    - die einwilligungsfähig sind und die Einverständniserklärung unterschreiben
    - die der deutschen Sprache ausreichend mächtig sind, um die neuropsychologische Testung durchführen zu können.
    E.4Principal exclusion criteria
    patients with a different cause of dementia than Alzheimer's disease;
    Patients with other severe neurological diseases (stroke, transient ischemic attack, brain tumor) in history;
    - Patients with chronic infectious underlying diseases with a possible neurological manifestation (syphilis, borreliosis) in the past history;
    - CRP> 20 mg / l
    - Patients with chronic liver disease (hepatitis B, C, autoimmune hepatitis) in history;
    - patients with unstable heart disease;
    - patients with severe kidney disease;
    - patients with insulin-dependent type 2 diabetes;
    - Patients with history of copper-bearing disease (Wilson's disease);
    - patients with acute infections;
    - patients with known allergy to Curazink;
    - Taking medication / drug groups that interact with Curazink according to the Specialist Information (11/2016):
    - tetracyclines,
    - ofloxacin,
    - other quinolones (ciprofloxacin, norfloxacin),
    D-penicillamine, DMPS ((RS) -2,3-disulfanylpropane-1-sulfonic acid),
    DMSA (dimercapto-succinic acid),
    EDTA (ethylenediamine tetraacetate),
    - Phosphates, iron, copper and calcium salts
    - Patient's participation in another clinical trial within the last 4 weeks prior to enrollment;
    - pregnant or breastfeeding women;
    - indications that the participant is unlikely to comply with the protocol (eg lack of cooperation);
    - Patienten mit einer anderen Ursache der Demenz als einer Alzheimerkrankheit;
    - Patienten mit anderen schweren neurologischen Erkrankungen (Schlaganfall, transiente ischämische Attacke, hirneigener Tumor) in der Vorgeschichte;
    - Patienten mit chronisch infektiösen Grunderkrankungen mit möglicher neurologischer Manifestation (Syphilis, Borreliose) in der Vorgeschichte;
    - CRP > 20 mg/l
    - Patienten mit chronischer Lebererkrankung (Hepatitis B,C, Autoimmunhepatitis) in der Vorgeschichte;
    - Patienten mit instabiler Herzerkrankung;
    - Patienten mit schwerer Nierenerkrankung;
    - Patienten mit insulinpflichtigem Diabetes Typ 2;
    - Patienten mit einer Kupferspeichererkrankung (Morbus Wilson) in der Vorgeschichte;
    - Patienten mit akuten Infektionen;
    - Patienten mit bekannter Allergie gegen Curazink;
    - Bei Einnahme von Medikamenten / Wirkstoffgruppen, die laut Fachinformation (11/2016) mit Curazink interagieren:
    - Tetracycline,
    - Ofloxacin,
    - andere Chinolone (Ciprofloxacin, Norfloxacin),
    - D-Penicillamin, DMPS ((RS)-2,3-Disulfanylpropan-1-sulfonsäure),
    - DMSA (Dimercapto-bernsteinsäure),
    - EDTA (Ethylendiamin-tetraacetat),
    - Phosphate, Eisen-, Kupfer- und Calciumsalze
    - Teilnahme der Patientin/des Patienten an einer anderen klinischen Prüfung innerhalb der letzten 4 Wochen vor dem Einschluss;
    - Schwangere oder stillende Frauen;
    - Anzeichen darauf, dass die teilnehmende Person den Prüfplan voraussichtlich nicht einhalten wird (z. B. mangelnde Kooperationsbereitschaft);
    E.5 End points
    E.5.1Primary end point(s)
    The first primary endpoint is the concentration of the C-reactive protein (CRP, acute phase protein).
    The second primary endpoint is the Alzheimer's Disease Assessment Scale Cognitive Subscale Test (ADAS-cog), which is expected to improve levels. The primary endpoints are tested in a hierarchical order and compared to placebo-group.
    Der erste primäre Endpunkt ist die Konzentration des C-reaktiven Proteins (CRP, Akute-Phase-Protein).
    Der zweite primäre Endpunkt ist der Alzheimer's Disease Assessment Scale-Cognitive Subscale test (ADAS-cog), bei dem eine Verbesserung der Werte erwartet wird. Die primären Endpunkte werden in hierarchischer Abfolge und im Vergelich zur Palacebogruppe getestet.
    E.5.1.1Timepoint(s) of evaluation of this end point
    It should be statistically assessed whether under an 8-week therapy with Curazink:
    - there is a significant decrease in inflammatory parameters
    - there is a significant improvement in cognitive performance,
    - evidence of an improvement in the quality of life is.
    For this purpose, an inflammatory parameter (CRP) and a parameter of cognitive performance (ADAS-cog) are considered to be the primary endpoints and checked confirmatory hierarchically in this order.
    Further parameters of inflammation and parameters of cognitive performance as well as parameters of quality of life and results of follow-up examinations after 12 weeks are considered as secondary parameters and examined in the exploratory sense. Safety information is given descriptively.
    Es soll statistisch beurteilt werden, ob unter einer 8-wöchigen Therapie mit Curazink:
    - eine signifikante Abnahme von Entzündungsparametern auftritt,
    - eine signifikante Verbesserung der kognitiven Leistungen eintritt,
    - eine Verbesserung der Lebensqualität nachzuweisen ist.
    Dazu werden ein Entzündungsparameter (CRP) und ein Parameter der kognitiven Leistung (ADAS-cog) als primäre Endpunkte betrachtet und in dieser Reihenfolge konfirmatorisch hierarchisch geprüft.
    Weitere Entzündungsparameter und Parameter der kognitiven Leistung sowie Parameter der Lebensqualität und Ergebnisse de Follow-up-Untersuchung nach 12 Wochen werden als sekundäre Parameter betrachtet und im exploratorischen Sinne geprüft. Angaben zur Sicherheit erfolgen deskriptiv.
    E.5.2Secondary end point(s)
    Secondary outcomes include different immunological laboratory parameters as well as another cognitive test and assessment of health-related quality of life.
    Laboratory parameters:
    • Plasma proinflammatory cytokine levels: IL-6
    • Levels of immunosuppressive cytokines in plasma: TGF-ß1, IL-10
    • Concentrations of the neuromodulatory cytokine BDNF in the plasma
    • Blood
    • immune status / distribution of immune cell populations
    Apolipoprotein E genotype
    Cognitive tests:
    • Minimal Mental Status Test (MMST)
    Life quality:
    • Short Form (36) Health Questionnaire (SF-36)

    The Short Form (36) Health Questionnaire is a disease-non-specific measurement tool for assessing health-related quality of life. The SF-36 is often used in medicine for therapy control or history measurement.
    Zu den sekundären Zielgrößen zählen sowohl verschiedene immunologische Laborparameter als auch ein weiterer kognitiver Test und die Beurteilung der gesundheitsbezogenen Lebensqualität.
    Laborparameter:
    • Konzentrationen proinflammatorischer Zytokine im Plasma: IL-6
    • Konzentrationen immunsuppressiver Zytokine im Plasma: TGF-ß1, IL-10
    • Konzentrationen des neuromodulatorischen Zytokins BDNF im Plasma
    • Blutbild
    • Immunstatus/Verteilung der Immunzellpopulationen
    • Apolipoprotein E-Genotyp
    Kognitive Teste:
    • Minimal Mental Status Test (MMST)
    Lebensqualität:
    • Short Form (36) Gesundheitsfragebogen (SF-36)

    Der Short Form (36) Gesundheitsfragebogen ist ein krankheitsunspezifisches Messinstrument zur Erhebung der gesundheitsbezogenen Lebensqualität. Der SF-36 wird häufig in der Medizin zur Therapiekontrolle oder Verlaufsmessung eingesetzt.
    E.5.2.1Timepoint(s) of evaluation of this end point
    It should be statistically assessed whether under an 8-week therapy with Curazink:
    - there is a significant decrease in inflammatory parameters
    - there is a significant improvement in cognitive performance,
    - evidence of an improvement in the quality of life is.
    For this purpose, an inflammatory parameter (CRP) and a parameter of cognitive performance (ADAS-cog) are considered to be the primary endpoints and checked confirmatory hierarchically in this order.
    Further parameters of inflammation and parameters of cognitive performance as well as parameters of quality of life and results of follow-up examinations after 12 weeks are considered as secondary parameters and examined in the exploratory sense. Safety information is given descriptively.
    Es soll statistisch beurteilt werden, ob unter einer 8-wöchigen Therapie mit Curazink:
    - eine signifikante Abnahme von Entzündungsparametern auftritt,
    - eine signifikante Verbesserung der kognitiven Leistungen eintritt,
    - eine Verbesserung der Lebensqualität nachzuweisen ist.
    Dazu werden ein Entzündungsparameter (CRP) und ein Parameter der kognitiven Leistung (ADAS-cog) als primäre Endpunkte betrachtet und in dieser Reihenfolge konfirmatorisch hierarchisch geprüft.
    Weitere Entzündungsparameter und Parameter der kognitiven Leistung sowie Parameter der Lebensqualität und Ergebnisse de Follow-up-Untersuchung nach 12 Wochen werden als sekundäre Parameter betrachtet und im exploratorischen Sinne geprüft. Angaben zur Sicherheit erfolgen
    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 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) 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 No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    Monitoring Close out visit
    Abschlussbesuch durch Klinischen Monitor
    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
    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) No
    F.1.3.1Number of subjects for this age range: 20
    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 state40
    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
    Nein
    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 Decision2018-10-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-18
    P. End of Trial
    P.End of Trial StatusOngoing
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