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    Summary
    EudraCT Number:2010-023322-21
    Sponsor's Protocol Code Number:NP031112-10B04
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-11-03
    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 number2010-023322-21
    A.3Full title of the trial
    A multicenter, Randomized, Double-blind, Placebo-controlled, 4-arm, 26 week Parallel-Group Study to evaluate the Efficacy, Safety and Tolerability of Two Oral Doses and Two Regimes of Tideglusib vs Placebo in Mild-to-Moderate Alzheimer Disease Patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tideglusib versus Placebo in Mild-to-Moderate Alzheimers Disease
    A.3.2Name or abbreviated title of the trial where available
    ARGO Study
    A.4.1Sponsor's protocol code numberNP031112-10B04
    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 SponsorNoscira S.A
    B.1.3.4CountrySpain
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nametideglusib
    D.3.2Product code NP031112-F06-037
    D.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNtideglusib
    D.3.9.1CAS number 865854-05-3
    D.3.9.2Current sponsor codeNP031112-F06-037
    D.3.9.3Other descriptive name4-benzyl-2-naphtalen-1-yl-1,2,4-
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboPowder for oral suspension
    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 (mild to moderate)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13.1
    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 evaluate the cognitive changes after administration of tideglusib vs. placebo at two oral doses and 2 treatment regimes for 26 weeks in patients with mild to moderate Alzheimer’s disease
    E.2.2Secondary objectives of the trial
    Key Secondary Objective:
    • To evaluate the safety and tolerability of two doses and two treatment regimes of
    tideglusib administered for 26 weeks in patients with mild-to-moderate Alzheimer’s
    disease.

    Other Secondary Objectives:
    • To evaluate other clinical changes in these patients after administration of tideglusib vs. placebo at 2 oral doses and 2 treatment regimes for 26 weeks:
    - patient daily functioning
    - behavior and depressive mood
    - overall clinical change
    - health related quality of life
    - caregiver time
    - urinary incontinence

    • To evaluate the safety and tolerability of tideglusib in patients administered over
    longer periods of time (more than 26 weeks; extension study).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women (of non-childbearing potential) with a diagnosis of probable
    Alzheimer’s disease, according to the NINCDS-ADRDA clinical criteria of AD and
    DSM-IV criteria of dementia.
    2. Age of 50 to 85 years (patients out of this range could be included after a previous
    assessment by the Investigator and approved by the sponsor).
    3. Brain MRI study within 12 months before the Baseline visit supporting the clinical
    diagnosis (e.g. diffuse, symmetric, brain atrophy predominating in medial temporal
    regions) and excluding other potential causes of dementia, especially cerebrovascular lesions (see exclusion criteria, number 2).
    4. Mild to moderate stage of Alzheimer’s disease according to MMSE score 14 to 26.
    5. Evidence of cognitive and/or functional decline in the past 6 months (in comparison
    with previous assessments) based either on a formal rating scale or a structured
    interview.
    6. No relevant depression as indicated by score in Geriatric Depression Scale below or equal to 10.
    7. Female patients must be either surgically sterilized or at least one year postmenopausal (confirmed by FSH >20, for women not surgically sterilized). Male patients must be willing to use barrier contraception (condom) during the study and for six months after the last treatment administration if their partners are women of child-bearing potential.
    8. Good general health, hydration and nutrition status for participating in this clinical trial
    9. Patients living at home or in long stay residential or care settings not requiring
    continuous and extensive nursing care; able to walk independently with or without a
    walking aid (e.g. cane or walker)
    10. Ability to swallow a water suspension.
    11. The patient and the caregiver are fluent in the language used for administration of the rating scales and cognitive tests and have sufficient visual, hearing, reading and writing skills to perform all the planned assessments.
    12. Well-tolerated treatment with one of the approved Acetylcholinesterase-Inhibitors (Donepezil, Galantamine or Rivastigmine) and/or Memantine in a stable dose for at least 4 months prior to baseline evaluations. Any of these drugs must be anticipated not to be started or adjusted during the ongoing study.
    13. A caregiver/nurse is available and is living in the same household or interacts with the patient at least 10 hours/week to assure the correct storage, preparation and administration of the study drug, as well as to provide information about patient’s physical and behavioral symptoms and changes.
    14. Patients and caregivers must be able to understand and agree to comply with the prescribed dosage regimens and procedures, attend regularly scheduled visits and reliably communicate effectively with the investigator team.
    15. Signed informed consent by patient (and/or legal representative if applicable) and caregiver prior to the initiation of any study-specific procedure.
    E.4Principal exclusion criteria
    1. Hospitalization within 4 weeks prior to or during the screening period (apart from preplanned hospitalization for a condition, which did not deteriorate since 4 weeks prior to the screening period), or change of chronic concomitant medication (except vitamin or nutritional supplements) within 4 weeks prior to baseline.
    2. Clinical, laboratory or neuroimaging findings consistent with:
    • other primary degenerative dementia, (dementia with Lewy bodies, Parkinson’s
    disease with dementia, fronto-temporal dementia, Huntington’s disease, Jacob-
    Creutzfeld Disease, Down’s syndrome, etc)
    • cerebrovascular disease as major, cortical, strategic (anterior thalamus, genu of
    internal capsule, or basal forebrain) infarction or more than 2 lacunar infarcts, or
    extensive white matter lesions scoring 3 in the Wahlund’s scale [Wahlund et al.,
    2001], or multi-infarct dementia.
    • other central nervous system lesions (hydrocephalus, severe head trauma, tumors,
    subdural hematomas or other relevant space occupying processes, etc.)
    • other relevant infectious, metabolic or systemic diseases affecting central nervous
    system (syphilis, juvenile onset diabetes mellitus, clinically significant vitamin B12,folate or thyroid deficiency, clinically significant serum electrolyte disturbances,
    etc.)
    3. A current DSM-IV diagnosis of schizophrenia, bipolar disorder or active major
    depression.
    4. Any chronic liver disease as indicated by out of range values of ALAT, ASAT or direct bilirubin, clinically relevant hepatic steatosis or other clinical manifestations of liver disease.
    5. Clinical or historical evidence of active hepatitis or positive serology for hepatitis B or C.
    6. History of hepatic drug intolerance or any significant drug allergy (such as Steven-
    Johnson syndrome, anaphylaxis).
    7. Any clinically significant, advanced or unstable disease that may interfere with primary or secondary variable evaluations, may bias the assessment of the clinical or mental status of the patient or put the patient at special risk, such as:
    • uncontrolled diabetes mellitus (HbA1c >8%)
    • renal insufficiency (serum creatinine >2mg/dl and creatinine clearance ≤ 60 mL/min
    according to Cockgroft-Gault formula)
    • respiratory insufficiency
    • myocardial infarction, unstable angina within 3 months before screening
    • heart failure, cardiomyopathy
    • persistent bradycardia (heart beat <50/min) or tachycardia (heart beat >100/min)
    • episodes of unstable or uncontrolled blood pressure (systolic >160 or <90 mm Hg,
    or diastolic >100 or <45 mm Hg) in the 2 months prior to Baseline visit.
    • atrioventricular block (type II / Mobitz II and type III), congenital long QT
    syndrome, sinus node dysfunction or a marked prolongation of QTc interval
    (repeated demonstration in ECGs of QTc interval >450 msec for males and >470
    msec for females using Fridericia’s formula: QTc = QT/cube root of RR).
    • active, peptic ulceration or gastrointestinal bleeding within 6 months
    • malignant tumors or metastases within 3 years except indolent prostate or skin
    malignancies (other than melanoma)
    8. Chronic daily drug intake of:
    • drugs metabolized by the CYP3A4 with narrow therapeutic window: acenocumarol,
    warfarin and digitoxin
    • systemic anticholinergics with relevant action on central nervous system
    • tricyclics, MAO inhibitors or opioid analgesics
    • sedatives with the exception of sleep inducers of short action or Lorazepam max
    1mg/day
    • neuroleptics except quetiapine (max 25 mg/day) or risperidone (max 1 mg/day)
    • nootropics such as piracetam, propentofylline, hydergine, vinpocetine, ginkgo
    biloba, coenzyme Q-10, idebenone, and their derivatives
    • paracetamol (more than 1000 mg/day)
    • centrally active anti-hypertensive drugs
    • immunosuppressants
    • systemic cortico-steroids
    • tacrine, lithium, valproic acid within 3 months prior to the baseline visit
    9. Suspected or known history of drug abuse or excessive alcohol intake. *
    10. Suspected or known allergy to any components of the study treatments.
    11. Enrollment in another investigational study within 3 months before the baseline visit.
    12. Any condition which in the opinion of the investigator makes the patient likely to be non-compliant.
    * More than 21 units per week for men and 14 for women; or consumption of more than 8 units in a single episode. 1 unit equals approximately 1 glass of wine, 250 mL of beer or 1 shot (25 mL) of a spirit.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint:
    The changes from Baseline of the 3 active study medication groups will be compared with the placebo group in:
    • Alzheimer’s Disease Assessment Scale – Cognitive subscale
    (ADAS-Cog+)
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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.8.3 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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 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
    Last subject last visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months21
    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 months21
    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.1.3Elderly (>=65 years) Yes
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects may be included that are not able to give consent personally. Where allowed by local regulation, in such instances consent will be taken by the legal representative of the subject.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state49
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 280
    F.4.2.2In the whole clinical trial 280
    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)
    N/A
    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 Decision2010-11-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-07-13
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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