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    Summary
    EudraCT Number:2011-000487-10
    Sponsor's Protocol Code Number:TC-1734-226-CRD-006
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-06-24
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2011-000487-10
    A.3Full title of the trial
    A Double-Blind, Positive Comparator, Randomized, Multicenter, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of AZD3480 (TC-1734-226) as Monotherapy in Patients with Mild to Moderate Dementia of the Alzheimer’s Type (AD).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Not applicable
    A.3.2Name or abbreviated title of the trial where available
    Not applicable
    A.4.1Sponsor's protocol code numberTC-1734-226-CRD-006
    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 SponsorTargacept, Inc.
    B.1.3.4CountryUnited States
    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 supportTargacept, Inc.
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportAstraZeneca
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationChiltern International
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address171 Bath Road
    B.5.3.2Town/ citySlough
    B.5.3.3Post codeSL1 4AA
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 1753 512000
    B.5.5Fax number+441753511116
    B.5.6E-mailRegulatory.Service@chiltern.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 nameAZD3480 or TC-1734-226
    D.3.2Product code AZD3480 or TC-1734-226
    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.3.8INN - Proposed INNAZD3480 also known as TC-1734
    D.3.9.1CAS number 691882-47-0
    D.3.9.2Current sponsor codeAZD3480 also known as TC-1734
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Aricept
    D.2.1.1.2Name of the Marketing Authorisation holderEisai, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameAricept
    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.3.8INN - Proposed INNDONEPEZIL HYDROCHLORIDE
    D.3.9.1CAS number 120011-70-3
    D.3.9.2Current sponsor codeDonepezil HCl
    D.3.9.4EV Substance CodeSUB13647MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Aricept
    D.2.1.1.2Name of the Marketing Authorisation holderEisai, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameAricept
    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.3.8INN - Proposed INNDONEPEZIL HYDROCHLORIDE
    D.3.9.1CAS number 120011-70-3
    D.3.9.2Current sponsor codeDonepezil HCl
    D.3.9.4EV Substance CodeSUB13647MIG
    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, hard
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    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
    Mild to Moderate Dementia of the Alzheimer’s Type (AD)
    E.1.1.1Medical condition in easily understood language
    Alzheimer’s
    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 14.0
    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
    To assess the efficacy of AZD3480 vs. donepezil as monotherapy in patients with mild to moderate Dementia of the Alzheimer’s Type (AD)
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of AZD3480 as monotherapy in patients with mild to moderate AD.

    To assess the pharmacokinetics of AZD3480 and to investigate pharmacokinetic/pharmacodynamic (PK/PD) relationships in patients with mild to moderate AD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. A clinical diagnosis of probable dementia of the Alzheimer’s type (Alzheimer’s disease; AD) per National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer’s Disease and Related Disorders Association (NINCDS-ADRDA) criteria at least 12 months prior to Screening, supported by brain imaging studies within the previous 6 months, and of mild to moderate severity as defined by a Mini-Mental State Examination (MMSE) score of 12 to 22.
    2. Age 60-85, males or females.
    3. Presence of a caregiver with significant proportion of time in contact with the subject and who will oversee administration of study drug during the trial.
    4. Able to complete tests assessments and to understand and sign an informed consent (with help of his/her legally authorized representative if needed).
    E.4Principal exclusion criteria
    1. Vascular dementia, verified per National Institute of Neurological Disorders and Stroke and Association Internationale pour la Rechererchi et l’Enseignement en Neurosciences (NINDS-AIRENS) criteria and as defined by a modified Hachinski ischemia score (HIS) score of > 4 (i.e., vascular dementia is consistent with a modified HIS > 4).
    2. Diagnosis or presence of other dementing illnesses.
    3. Use of mood stabilizers, antidepressants, anxiolytics, antipsychotics or hypnotics.
    4. Treatment within 1 month prior to Screening using cognition-affecting agents (e.g., CNS stimulants).
    5. Tobacco user within 4 months prior to Screening.
    6. Use of smoking cessation therapy within 4 months prior to Screening.
    7. Use of prohibited concomitant medications (see protocol Section 5.3.2. and Appendix 12).
    8. History within past 6 months of alcohol abuse or illicit drug abuse.
    9. Unable, even with caregiver assistance, to comply with study procedures in opinion of investigator.
    10. History of significant other major or unstable neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, or urological disorder: or diagnosis of major depressive disorder.
    11. Myocardial infarction within 12 months prior to Screening.
    12. Uncontrolled hypothyroidism, vitamin B12 or folic acid deficiency.
    13. Known systemic infection (HBV, HCV, HIV, TB).
    14. Clinically significant finding on baseline physical examination.
    15. Clinically significant baseline laboratory or ECG abnormality, including QTcF > 450 msec.
    16. The subject is pregnant.
    17. Males or WOCBP (FSH >35 IU/L and a LH level >25 IU/L) who are unwilling to comply with contraceptive measures as described in the protocol.
    18. Malignancies other than benign skin cancers
    19. Participation in another clinical trial in the past 6 months.
    E.5 End points
    E.5.1Primary end point(s)
    -The change in the Alzheimer’s Disease Assessment Scale - Cognitive
    Subscale (ADAS-Cog) total score from Baseline to Week 52.
    -The change in the Alzheimer’s Disease Cooperative Study – Activities
    of Daily Living (ADCS-ADL) total score from Baseline to Week 52.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary endpoints (ADAS-Cog and ADCS-ADL) are assessed at Week -3 (Screening), Day 1 (Baseline and Randomization), Week 4, Week 12, Week 24, Week 36, Week 52 or Early Withdrawal (Final Study Period Visit), and Week 54 (Follow-up Visit).
    E.5.2Secondary end point(s)
    Key Secondary Efficacy Endpoints
    -The change in the Clinician Interview-Based Impression of Change Plus
    Caregiver Input (CIBIC-(+)) from Baseline to Week 52.
    -The change in the Neuropsychiatric Inventory (NPI) total score
    from Baseline to Week 52.

    Other Secondary Efficacy Endpoints
    -The change in the Mini-Mental State Examination (MMSE) total
    score from Baseline to Week 52.
    -The proportion of responders (defined as the proportion of subjects with >/= 1 point improvement from Baseline on ADAS-Cog and no deterioration in CIBIC-(+) or ADCS-ADL at Weeks 24 and 52.
    -The change in ADAS-Cog, CIBIC-(+), ADCS-ADL, and MMSE total scores from Baseline to Weeks 4, 12, 24, 36.
    -The change in the ADRQL total score from Baseline to Week 24 and 52.
    -The change in the NPI total score from Baseline to Weeks 12, 24 and 36.
    -The change in the Resource Utilization in Dementia (RUD) from baseline to week 52.

    Safety Endpoints
    -The frequency of clinically significant changes in physical examination
    findings
    -The frequency of volunteered non-serious AEs and SAEs
    -Changes in vital signs (including orthostatic blood pressure and heart rate)
    -Changes in ECG findings.
    -Changes in clinical laboratory tests (including hematology, plasma
    biochemistry, liver function tests (LFTs), and urinalysis). The proportion of values outside of the Targacept (TRGT) reference ranges will be determined.
    -Urinary cotinine values
    -Changes in scores on the Columbia Suicide Severity Rating Scale (CSSRS)

    -Pharmacokinetic exposure parameters for AZD3480 will be estimated based on pre-dose and post-dose values, as appropriate.

    -Pharmacogenetic endpoints: the key efficacy endpoints will be categorized by Apolipoprotein E (ApoE) allele status.

    -Pharmacokinetic/Pharmacodynamic analysis will be performed on efficacy endpoints including ADASCog and CIBIC-(+). Other efficacy and safety endpoints may be evaluated, as appropriate.
    E.5.2.1Timepoint(s) of evaluation of this end point
    -NPI Day (D) 1, Week (W) 12, W24, W36, W52 or Early Withdrawal (EW)
    -ADRQL D1, W24, W52 or EW
    -RUD D1, W52 or EW
    -CIBIC-(+), ADCS-ADL W-3, D1, W4, W12, W24, W36, W52 or EW, W54
    -MMSE W-3, D1, W4, W12, W24, W36, W52 or EW
    -Physical examination W-3, D1, W4, W12, W24, W52 or EW, W54
    -CSSRS and Assessment of AEs W-3, D1, W1, W4, W12, W24, W36, W52 or EW, 54
    -Vital signs including orthostatic BP and heart W-3, D1, W1, W4, W12, W24, W36, W52 or EW, W54; and additional orthostatic BP and heart rate pre-dose and post-dose D1, W52 or EW, W54
    -ECG W-3, D1, W1, W24, W52 or EW, W54 (as needed)
    -Clinical laboratory tests W-3, W4, W12, W24, W52 or EW, W 54 (as needed)
    -Urinary cotinine test W-3, W52 or EW
    -PK blood samples (sparse) D1, W24, W52
    -ApoE allele blood sample W-3
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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) Yes
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA19
    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
    Czech Republic
    Romania
    Slovakia
    Ukraine
    United States
    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
    The end of treatment period is Week 52, and the end of study participation (i.e., last patient visit) is the Week 54 follow-up visit.
    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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 240
    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
    Informed consent will be based on the subject's consent and, if the subject cannot provide consent, then by the subject's legal representative. The Informed Consent document will be structured to provide for either scenario.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 216
    F.4.2.2In the whole clinical trial 300
    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)
    Not applicable
    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 Decision2011-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-05-27
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