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    Summary
    EudraCT Number:2009-011881-27
    Sponsor's Protocol Code Number:ADAM
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-01-20
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-011881-27
    A.3Full title of the trial
    Changes of cerebral spinal fluid APPSα levels under oral therapy with acitretin 30 mg daily in patients with mild to moderate Alzheimer’s disease: a multicenter prospective randomised placebo-controlled parallel-group study.
    Veränderungen der APPSα -Konzentration in der Zerebrospinalflüssigkeit nach der oralen Therapie mit 30 mg Acitretin täglich bei Patienten mit leichter bis mittelschwerer Alzheimer-Krankheit: multizentrische prospektive randomisierte placebo-kontrollierte Studie mit Parallelgruppen-Design.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Changes of cerebral spinal fluid APPSα levels under oral therapy with acitretin 30 mg daily in patients with mild to moderate Alzheimer’s disease: a multicenter prospective randomised placebo-controlled parallel-group study.
    Veränderungen des APPSα Spiegels unter oraler Therapie mit 30 mg Acitretin bei Patienten mit leichter bis mittelgradiger Alzheimer Erkrankung: eine multizentrische, prospektive, randomisierte, placebokontrollierte Parallelgruppenstudie
    (ADAM Studie)
    A.3.2Name or abbreviated title of the trial where available
    Alzheimer´s Disease Acitretin Medication (ADAM)
    Medikation der Alzheimer Krankheit mit Acitretin (ADAM)
    A.4.1Sponsor's protocol code numberADAM
    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 SponsorUniversity Medical Center of the Johannes Gutenberg-University Mainz
    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 supportUniversity Medical Center of the Johannes Gutenberg-University Mainz
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center of the Johannes Gutenberg-University Mainz
    B.5.2Functional name of contact pointAndreas Fellgiebel
    B.5.3 Address:
    B.5.3.1Street AddressUntere Zahlbacher Str. 8
    B.5.3.2Town/ cityMainz
    B.5.3.3Post code55131
    B.5.3.4CountryGermany
    B.5.4Telephone number004906131176786
    B.5.5Fax number004906131176690
    B.5.6E-mailfellgiebel@psychiatriie.klinik.uni-mainz.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 Neotigason
    D.2.1.1.2Name of the Marketing Authorisation holderActavis Group PTC ehf
    D.2.1.2Country which granted the Marketing AuthorisationIceland
    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 nameNeotigason
    D.3.4Pharmaceutical form Capsule
    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 INNACITRETIN
    D.3.9.1CAS number 55079839
    D.3.9.2Current sponsor codeD05BB
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 placeboCapsule
    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
    Alzheimer’s disease
    Alzheimer-Krankheit
    E.1.1.1Medical condition in easily understood language
    Alzheimer’s disease
    Alzheimer-Krankheit
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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 prove the mechanism of action of acitretin in AD patients. The increase of CSF APPSα levels in patients treated with acitretin should indicate the activation of the non-amyloidigenic pathway of APP processing via α-secretase.
    Das primäre Ziel ist die Prüfung der Wirksamkeit einer Acitretin-Therapie bei Alzheimer-Krankheit.
    E.2.2Secondary objectives of the trial
    To assess the plasma and CSF concentrations of acitretin
    To assess cognitive performance under acitretin therapy
    To assess the stability in activities of daily living under acitretin therapy
    To assess the stability of neuropsychiatric symptoms under acitretin therapy
    To compare the safety and tolerability of 30mg acitretin daily in AD patients
    To assess the changes in CSF β-Amyloid concentration
    Messungen der Acitretin-Konzetration im Plasma und in der Zerebrospinalflüssigkeit
    Messungen der kognitiven Leistungen unter der Acitretin-Therapie
    Veränderungen der CSF-Biomarker für die APP-Prozessierung
    Sicherheit und Verträglichkeit der Acitretin-Therapie
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    mild to moderate AD (NINCDS-ADRDA criteria)
    MMSE according to Folstein: 27-14 points
    Geriatric Depression Scale ≤ 14
    age ≥ 50 years
    ability of subject to understand character and individual consequences of clinical trial
    leichte bis mittelschwere Alzheimer-Krankheit (nach NINCDS-ADRDA Kriterien)
    MMSE: 27-14 Punkte
    Geriatric depression scale ≤ 14
    Alter ≥ 50 Jahre
    Der Prüfungsteilnehmer ist in der Lage, Art, Umfang und individuelle Konsequenzen der klinischen Prüfung zu verstehen
    E.4Principal exclusion criteria
    hereditary cognitive impairment
    known history of brain injuries
    Insufficient German language skills
    actual treatment with other potential disease modifying drugs of AD
    multimorbidity or significant organ (esp. liver or renal) dysfunction
    evidence of Non-AD neurodegenerative disorder (e.g. Parkinson)
    contraindication to acitretin such as osteoporosis, hypoalbuminaemia
    Angeborene kognitive Behinderungen
    Bekannte Gehirnverletzungen
    Unzureichende deutsche Sprachkenntnisse
    Laufende Therapie mit anderen anti-AD Medikamenten
    Multimorbidität oder schwere Erkrankungen relevanter Organe (z. B. Leber, Nieren)
    andere als AD neurodegenerative Erkrankungen (z. B. Parkinson-Krankheit)
    Kontraindikationen zu Acitretin (z. B. Osteoporose, Hypoalbuminämie)
    E.5 End points
    E.5.1Primary end point(s)
    The difference in CSF APPSα concentration at Visit 3 (day 30) compared to Baseline (day 0).

    Veränderungen der APPSα -Konzentration in der Zerebrospinalflüssigkeit zwischen Baseline und Visite 3
    E.5.1.1Timepoint(s) of evaluation of this end point
    The difference in CSF APPsα concentration at Visit 3 compared to baseline will be analysed by an analysis of covariance (ANCOVA) with factors baseline CSF APPsα, treatment group and centre. The analysis will be performed on a two-sided level of significance α=0.05.
    Der primäre Endpunkt wird mit einer ANCOVA unter Berücksichtigung folgender Faktoren ausgewertet: APPSα -Konzentration in der Zerebrospinalflüssigkeit bei der Baseline, Behandlungsgruppe und Prüfzentrum. Tests auf Unterschiede in den Behandlungsgruppen werden auf dem zweiseitigen Signifikanzniveau α = 0.05 durchgeführt.
    E.5.2Secondary end point(s)
    cognitive performance, defined as CERAD test battery performance
    activities of daily living, defined as Bayer ADL test scores
    neuropsychiatric symptoms, defined NPI test scores
    difference in CSF Abeta concentration at Visit 3 compared to Baseline
    difference in acitretin plasma concentration at Visit 3 compared to Visit 2
    acitretin CSF concentration at Visit 3
    safety and tolerability
    Kognitive Leistungen, gemessen anhand der CERAD-Tests
    Lebensqualität, , gemessen anhand des Bayer ADL Tests
    Neuropsychiatrische Symptome, gemessen anhand des NPI Tests
    Veränderungen der CSF-Abeta-Konzentration zwischen Baseline und Visite 2
    Veränderungen der Acitretin Plasmakonzentration zwischen Visite 2 und Visite 3
    Acitretin CSF-Konzentration bei Visite 3
    Sicherheit und Verträglichkeit: Auftreten unerwünschter Ereignisse, Laborwerte
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary endpoints will be analysed by exploratory methods and descriptive statistics only.
    Die sekundären Endpunkte und alle anderen Daten werden deskriptiv ausgewertet.
    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 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 Information not present in EudraCT
    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
    provided in protocol
    siehe protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years36
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    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: 38
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 38
    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 state76
    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)
    Trial participants will receive treatment as clinically indicated after completion of protocol treatment.
    Studienteilnehmer erhalten nach der klinischen Prüfung entsprechende Behandlung.
    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 Decision2010-02-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-05-15
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