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    Summary
    EudraCT Number:2016-001049-24
    Sponsor's Protocol Code Number:ACW0002
    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:2016-12-23
    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 ConcernedUK - MHRA
    A.2EudraCT number2016-001049-24
    A.3Full title of the trial
    XanADu: A Phase II, Double-Blind, 12-Week, Randomised, Placebo-Controlled Study
    to Assess the Safety, Tolerability and Efficacy of Xanamem™ in Subjects with Mild
    Dementia due to Alzheimer’s Disease (AD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess whether of Xanamem™ is safe, well tolerated and effictive when given to patients with mild Dementia due to Alzheimer’s disease.
    A.3.2Name or abbreviated title of the trial where available
    XanADu
    A.4.1Sponsor's protocol code numberACW0002
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1177-5932
    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 SponsorActinogen Medical
    B.1.3.4CountryAustralia
    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 supportActinogen Medical
    B.4.2CountryAustralia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationICON Clinical Research Pty Ltd
    B.5.2Functional name of contact pointProject Management
    B.5.3 Address:
    B.5.3.1Street AddressSuite 201, Level 2, 2 - 4 Lyon Park Road
    B.5.3.2Town/ cityNorth Ryde, Sydney
    B.5.3.3Post codeNSW 2113
    B.5.3.4CountryAustralia
    B.5.4Telephone number+61298593907
    B.5.5Fax number+61280022867
    B.5.6E-mailtom.olson@iconplc.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 nameXanamem™ 10 mg capsules
    D.3.2Product code UE2343
    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 INNNot available
    D.3.9.1CAS number 1346013-80-6
    D.3.9.3Other descriptive nameUE2343
    D.3.9.4EV Substance CodeSUB92218
    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
    Mild Dementia due to Alzheimer’s Disease
    E.1.1.1Medical condition in easily understood language
    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 PT
    E.1.2Classification code 10012271
    E.1.2Term Dementia Alzheimer's type
    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
    The primary objective of the study is to evaluate the extent to which Xanamem™ improves performance from Baseline to end of treatment (EOT) compared to placebo, as measured by changes in AD COMposite Scores (ADCOMs, composite data derived from Alzheimer's Disease Assessment Scales - Cognitive subscale version 14 [ADAS-Cog v14], Clinical Dementia Rating Scale - Sum of Boxes [CDR-SOB], and Mini-Mental Status Examination [MMSE]) and ADAS-Cog v14 as primary endpoints in subjects with mild dementia due to probable AD.
    E.2.2Secondary objectives of the trial
    To assess the extent to which Xanamem™ will improve performance from Baseline to EOT compared to placebo, as measured by changes to:
    • Rey Auditory Verbal Learning Test (RAVLT)
    • CDR-SOB
    • MMSE
    • Neuropsychiatric Inventory (NPI)
    • Neuropsychological Test Batteries (NTB) – Executive Domain
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Substudy 1
    Title: Optional PD assessment:
    The objective of this is to assess the impact of Xanamem™ on the hypothalamic-pituitary-adrenal axis.

    E.3Principal inclusion criteria
    1. Males and females aged 50 years or older at the time of informed consent.
    2. Female subjects:
    a) Post menopausal women, defined as no menses for 12 months without an alternative medical cause. If there is any concern about the menopausal status of a prospective female subject, a follicle stimulating hormone (FSH) test should be requested to confirm post menopausal status. Post-menopausal women confirmed by FSH level > 40 mIU/mL, will be confirmed by central laboratory.
    b) WOCBP must have a negative pregnancy test at Screening and Baseline and be willing to use highly effective methods of contraception from the Screening visit until 3 months after last dose of study drug. The central laboratory will flag positive serum human chorionic gonadotropin as exclusionary at Screening (re-test of Screening if required).
    In such cases, the site will perform a local urine pregnancy test at Baseline to determine if the subject can continue to randomisation (see Appendix IV for more information)
    c) Are permanently sterile or have had a hysterectomy, bilateral salpingectomy or bilateral oophorectomy.
    d) Women must not be breastfeeding
    3. Male subjects:
    a) Who are sexually active, fertile men must use highly effective methods of contraception from Day 1 until 3 months after last dose of study drug if their partners are WOCBP (see Appendix IV for more information).
    b) Who are permanently sterile or have had bilateral orchiectomy.
    4. Diagnosis of mild dementia due to probable AD with increased level of certainty (provided by evidence of clinical deterioration within the 6 months preceding Screening, as assessed by the investigator) as determined by the National Institute of Ageing (NIA) and the Alzheimer’s Association (AA) workgroup.
    5. Mild dementia due to probable AD with MMSE of 20 to 26 (inclusive).
    6. CDR Global Score of 0.5 to 1.0.
    7. A brain magnetic resonance imaging (MRI) or computed tomography (CT) scan in the 12 months preceding Screening (a wider window may be accepted but requires written approval by the ICON Medical Monitor (MM)) that, in the investigator’s opinion, is consistent with AD as the principal aetiology of the dementia with no other clinically significant abnormality, e.g. another principal underlying aetiology of the subject’s dementia, or a lesion which could affect cognition e.g. a brain tumour or large stroke.
    8. On stable dose of acetylcholinesterase inhibitor (AChEI) and/or memantine (at least 3 months prior to Screening) OR treatment-naïve. Initiating AChEIs or memantine during the study will not be permitted.
    9. Apart from a clinical diagnosis of mild dementia due to probable AD, the subject must be in good health as determined by the investigator, based on medical history and screening assessments.
    10. Has a consenting study partner who, in the investigators judgement, has frequent and sufficient contact with the subject to be able to provide accurate information as to the subject’s cognitive and functional abilities. The study partner must be available to provide information to the investigator and study site staff about the subject and agrees to attend all study site visits in person for scale completion. A study partner should be available for the duration of the study. The measure of adequate availability will be at the investigators discretion.
    11. Must be willing and able to comply with the requirements of the protocol and must be available to complete the study.
    12. Must satisfy a medical examiner about their fitness to participate in the study.
    13. Must provide written informed consent to participate in the study.
    E.4Principal exclusion criteria
    1. Clinically significant abnormalities in vital signs (blood pressure, heart rate, respiration rate and oral temperature), as determined by the investigator.
    2. Clinically significant abnormal haematology, biochemistry and urine examination values, as determined by the investigator. Additionally, abnormal liver and renal function and Vitamin B12 levels below lower threshold may impact cognitive function. The following values will have an alert flag on the laboratory report and are specifically excluded:
    a) Vitamin B12 < 176 pg/mL
    b) Haemoglobin ≤ 11 g/dL for females and ≤ 12 g/dL for males
    c) Aspartate aminotransferase > 3 x upper limit of normal (ULN)
    d) Alanine aminotransferase > 3 x ULN
    e) Serum creatinine > 2 x ULN
    f) Urine benzodiazepines when positive: One re-test will be allowed in cases where the subject’s intake of benzodiazepines is within the allowed dose. Re-tests must be performed within 7 days of the last benzodiazepine dose prior to the Baseline visit. A positive re-test for urine benzodiazepines is exclusionary.
    3. Has had a significant systemic illness or infection within the past 4 weeks prior to randomisation, as determined by the investigator.
    4. Clinically significant neurological disease other than AD, such as (but not limited to) Parkinson’s disease, multi-infarct dementia, Huntington’s disease, normal pressure hydrocephalus, brain tumour, progressive supranuclear palsy, seizure disorder, subdural haematoma, multiple sclerosis or a history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.
    5. Subjects with clinical evidence of peripheral neuropathy or historical evidence of clinically significant nerve conduction abnormalities. Clinical evidence of neuropathy is defined as:
    a) Inability to sense a stimulus even at the secondary (more proximal) skin area for pinprick, light touch, and vibration or temperature at the foot, in at least one extremity (in case of neurography measures are normal, the case will be discussed with the ICON MM to assess subject eligibility.
    b) Nerve conduction abnormalities beyond local normal values or inability to measure SNAP or CMAP in the primary or a secondary (back-up) nerve
    c) NTSS-6 score > 6, but note that subjects are eligible even if they show:
    • Missing reflexes of the Achilles tendon (ankle), but a positive patellar (knee) tendon reflex
    • Missing ability to name toe or thumb position
    6. Has had a stroke within the year prior to randomisation, as determined by the investigator.
    7. Has a lifetime diagnosis of a major psychiatric disorder (other than dementia), based on the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition criteria. This includes but is not limited to schizophrenia, schizoaffective disorder, bipolar affective disorder, alcohol dependence syndrome or major depressive disorder.
    8. Has a history of disease directly related to the hypothalamus, the pituitary and/or the adrenal glands which affect the hypothalamic-pituitary-adrenal axis function.
    9. Has uncontrolled clinical conditions relating to glucose and lipid metabolism.
    10. Clinically significant ECG abnormalities, including QTc interval > 450 msec, following ECG tracings at Screening. A single repeat evaluation will be allowed if the investigator or designee has reason to believe the reading is faulty or to help assess the clinical significance of an abnormality. Any other ECG abnormality that is seen as exclusionary will first be discussed with the ICON MM.
    11. Use of any prohibited medication (see Section 10.8 of the Protocol for details).
    12. Participation in another clinical study of an investigational drug or device whereby the last drug/device administration is within 60 days of Screening.
    13. Inability to communicate well with the investigator (i.e. language problem, non-fluent English [as scales will be provided in English only], poor mental development or impaired cerebral function).
    14. Subject will undergo the tests, ADAS-Cog v14, CDR-SOB, MMSE, NTB (executive domain) and RAVLT at the indicated time-points to avoid uncontrolled learning effects.
    Subjects who need to perform these tests externally to and in parallel with this study will be excluded.
    15. Subject has ingested any food or drink containing grapefruit, Seville oranges, star fruit, or derived products (e.g. fruit juice), for at least 3 days prior to the first administration of study drug. Subjects must be willing to abstain from ingesting these foods and drinks throughout the study, as it may interfere with the activity of Xanamem™.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy:
    The two primary efficacy variables are:
    1) The change from Baseline (Week 0) to Week 12 /(end of treatment, EOT) in the Alzheimers Disease COMposite Score (ADCOMs), a composite score based on Alzheimer's Disease Assessment Scale - Cognitive subscale, version 14 (ADAS-Cog v14), Clinical Dementia Rating scale - Sum of Boxes (CDR-SOB) and Mini-Mental Status Examination (MMSE).

    2) The change from Baseline (Week 0) to Week 12/EOT in the ADAS-Cog v14.

    Multiplicity between both primary endpoints will be handled using an a priori hierarchical approach, such that the results for the ADAS-Cog v14 will only be interpreted in a confirmatory fashion if results for the ADCOMs allowed a rejection of the null hypothesis.

    Safety Variables:
    •Clinical safety laboratory values
    • Adverse Events (AEs), serious adverse events (SAEs) and AEs of special interest (AESIs)
    • Electrocardiogram (ECG)
    • Nerve Function Monitoring (NFM)
    o Neuropathy Total Symptom Score (NTSS-6)
    o Toronto Clinical Neuropathy Score (TCNS)
    o NCV and amplitude of peripheral motor and sensory nerves
    o Vibration and Thermal Perception
    • Columbia Suicide Severity Rating Scale (CSSRS)
    • Physical examination
    • Vital signs

    Pharmacokinetic (PK) and Pharmacodynamic (PD) Variables:
    • PK assessment
    • PD assessment (in subjects who consent to participating in PD assessment): A Adrenocorticotropic Hormone (ACTH), Dehydroepiandrosterone sulfate (DHEAS), androstenedione and testosterone
    E.5.1.1Timepoint(s) of evaluation of this end point
    Efficacy: Baseline, Week (Wk)12/End of Treatment (EOT)

    Safety:
    • Clinical safety laboratory values:Screening, Baseline, Wks 4,8,12/EOT,
    at follow-up
    • AEs, SAEs, AESIs:Screening, Baseline, Wks 4,8, adhoc telephone
    contact, Week 12/EOT, follow-up visit, unscheduled safety visit
    • ECG:Screening, Baseline, Wks 4,8,12/EOT, follow-up visit
    • NFM:Screening, Baseline, Wks 4,8,12/EOT, follow-up visit
    • NTSS-6:Screening, Baseline, Wks 4,8, adhoc telephone contact, Wk
    12/EOT, follow-up visit
    • CSSRS:Screening, Wks 4,8,12/EOT, follow-up visit
    • Physical Examination and vital signs:Screening, Baseline, Wks 4,8,12/EOT, follow-up visit, unscheduled safety visit

    PK and PD assessments:
    • PK:Baseline, Wks 4,8,12/EOT, unscheduled safety visit
    • PD:Baseline, Wks 4,8,12/EOT, follow-up visit
    E.5.2Secondary end point(s)
    Efficacy
    The following secondary efficacy variables will be evaluated:
    • Rey Auditory Verbal Learning Test (RAVLT)
    • Clinical Dementia Rating scale - Sum of Boxes (CDR -SOB)
    • Mini-Mental Status Examination (MMSE)
    • Neuropsychiatric Inventory (NPI)
    • Neuropsychological Test Batteries (NTB) – Executive Domain (COWAT and CFT)
    E.5.2.1Timepoint(s) of evaluation of this end point
    • RAVLT: Baseline and Week 12/End of Treatment
    • CDR –SOB: Screening, Baseline, Week 12/End of Treatment
    • MMSE: Screening, Baseline, Week 12/End of Treatment
    • NPI (care-giver only): Baseline and Week 12/End of Treatment
    • NTB – Executive Domain: Baseline and Week 12/End of Treatment
    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 Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Pharmacodynamic (PD) - only in 50 subjects enrolled into the main study who also volunteer to take part in the PD sub-study.

    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 Yes
    E.8.1.7.1Other trial design description
    Proof-of-concept
    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 concerned6
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    United Kingdom
    United States
    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 years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    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: 7
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 167
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects who do not have the capacity to provide consent about study participation due to the severity of their disease
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Subjects admitted to hospital without their consent and have since recovered capacity to consent
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 174
    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
    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 Decision2017-02-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-15
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