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    Summary
    EudraCT Number:2008-004012-13
    Sponsor's Protocol Code Number:WN22018
    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:2009-07-27
    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 number2008-004012-13
    A.3Full title of the trial
    A dose ranging, randomized, double blind, parallel-group placebo-controlled multi-center study of RO5313534 used as add-on to donepezil treatment in patients with mild to moderate symptoms of Alzheimer’s Disease

    A.4.1Sponsor's protocol code numberWN22018
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 namenicotinic alpha 7
    D.3.2Product code RO5313534/F02 (MEM3454)
    D.3.4Pharmaceutical form Capsule, hard
    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 INNn/a
    D.3.9.1CAS number 667305-02-1
    D.3.9.2Current sponsor codeRO5313534-001
    D.3.9.3Other descriptive nameMEM3454
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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.IMP: 2
    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 namenicotinic alpha 7
    D.3.2Product code RO5313534/F03 (MEM3454)
    D.3.4Pharmaceutical form Capsule, hard
    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 INNn/a
    D.3.9.1CAS number 667305-02-1
    D.3.9.2Current sponsor codeRO5313534-001
    D.3.9.3Other descriptive nameMEM3454
    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) 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 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 to moderate Alzheimer’s Disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    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 is to evaluate efficacy of 24 weeks treatment of 3 fixed doses of RO5313534 (1, 5 and 15 mg/day) added to donepezil (5 or 10 mg/day) on a cognitive endpoint (measured with the ADAS-Cog) as compared to placebo added to donepezil.
    E.2.2Secondary objectives of the trial
    1. To evaluate the tolerability and safety of 24 weeks treatment of the 3 fixed doses of RO5313534 (1, 5 and 15 mg/day) as adjunctive therapy of donepezil (5 or 10 mg/day).
    2. To evaluate efficacy on behavioral, global and functional endpoints
    3. To evaluate on cognitive endpoints measured with the cognitive battery CANTAB (The Cambridge Neuropsychological Test Automated Battery)
    4. To evaluate maintenance of efficacy (primary and secondary variables) 4 weeks after discontinuation of treatment
    5. To investigate by a population PK analysis approach the pharmacokinetics of RO5313534 in the target population, including the influence of covariates such as age, gender, body-weight and renal function.
    6. To explore the relationship between PK exposure and response using population PK-PD methods.
    7. To evaluate whether the genetic markers of APOEε4, Nicotinic alpha7 and duplicated alpha 7 are predictive of response to RO5313534 treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Probable AD, based on the NINCDS/ADRDA and DSM-IV criteria.
    2. Males, females of non-childbearing potential (more than two years after the cessation of menses or surgically sterile by means of hysterectomy, bilateral oopherectomy or tubal ligation). Additional blood tests will be done if required by the local regulations/guidelines/EC/IRB for further confirmation of non-childbearing potential.
    3. Age range: A minimum of 50 years of age at the time of screening visit.
    4. Non smokers and not using nicotine-containing products for at least 3 months prior to baseline.
    5. Have a MMSE score at screening between 13 and 22 inclusive.
    6. Have a Modified Hachinski Ischemia Scale score of ≤ 4 (see Appendix 5)
    7. Are under stable donepezil treatment given at a fixed dose either 5 or 10 mg daily for at least 4 months prior to baseline.
    8. Adequate vision & hearing (physical ability to perform all the study assessments).
    9. Not requiring nursing home care.
    10. Have a caregiver or some other identified responsible person (e.g., family member, social worker, caseworker or nurse) who is considered reliable by the Investigator to provide support to the patient to ensure compliance with study treatment, accompany patient to study visits and help with protocol procedures, and who is also able and willing to provide input for completing the caregiver scales and sign the caregiver consent form.
    11. Are cooperative, willing and able to complete all aspects of the study, and capable of doing so either alone or with the help of a responsible caregiver. Patients who make an effortful attempt to perform CANTAB at screening but are unable to complete all aspects may be considered eligible if other eligibility criteria are met.
    12. Signed a written consent for participation in the study (co-signed by the patient’s next of kin or caregiver, if required by the local regulations/guidelines/EC/IRB).
    E.4Principal exclusion criteria
    1.Dementia due to condition other than AD
    2.Other significant neurological disorder, including current diagnosis of epilepsy, stroke, history of brain injury, Parkinson’s disease
    3.Background of mental retardation
    4.Untreated/non stabilized Major Depressive Disorder
    5.Bipolar disorder, schizophrenia or any serious psychiatric condition 6.At risk of suicide in the opinion of the investigator
    7.Uncontrolled behavioral symptoms incompatible with compliance or evaluability
    8.Alcohol and/or substance abuse or dependence in the past 2 yrs
    9.Unstable or poorly controlled hypertension
    10.Unstable or clinically significant cardiovascular disease that could be expected to progress, recur or change
    11.Patients with a screening QTcF >450 msec (males) or >470 msec (females), Patients who have a pacemaker rhythm with non-evaluable QTc are to be excluded as well. Note: pacemaker patients who have an evaluable QTc are eligible if screening QTcF is < 450 msec (males) or < 470 msec (females) (e.g. patients with atrial pacemaker or demand pacemaker).
    12.Screening AST, ALT or total bilirubin ≥2 times the upper limit of normal (ULN)
    13.Screening creatinine clearance <30 mL/min14.History of HIV ,Hep B, or Hep C infection
    15.Hep B surface Antigen and/or Hep C core antibodies positivity
    16.Screening thyroid function tests that are clinically significantly abnormal 17.Screening folic acid or B12 levels that are clinically significantly abnormal)
    18.Poorly controlled diabetes (Hb1Ac≥ 9% at screening)
    19.BMI >36 at screening
    20.History of cancer with survival expected to be less than 3 yrs or within the next 3 yrs may require systemic treatment. Except for localized, non recurrent treated skin cancer and stabilized prostate adenocarcinoma
    21.Any other medical condition not previously mentioned that could be expected to progress, recur, or change to such an extent that it could bias the assessment of the clinical or mental status of the patient to a significant degree or put the patient at special risk
    22.Clinically significant abnormal blood or urine safety tests
    23.Positive result for either drug of abuse, alcohol breath test or continine test
    24.Recent (within 60 days of screening) intake of investigational drug 25.Does not make an effortful attempt to perform CANTAB and ADAS-Cog 26.Treatment for Alzheimer’s disease other than donepezilare not permitted
    •Nutritional supplements used at doses higher than Recommended Daily Intake, Ginkgo, huperizine, lecithin
    within 2 wks before baseline are not permitted.
    •Nutritional supplements are permitted, if not taken in high doses
    and the patient is on a stable dose at least 3 months prior to screening. Huperizine within 2 weeks before baseline is not permitted.
    •Estrogen hormone replacement, NSAIDs within 2 wks before baseline are not permitted (unless treat conditions other than AD)
    27.Psychotropic medication
    •Antidepressants use within 2 wks before screening are not permitted, except
    antidepressant medication with minimal or no anticholinergic effects, Trazodone treatment for depression is permitted.
    •Anti-psychotic use within 4 wks before screening are not permitted except haloperidol, risperidone or quetiapine at given max dose
    •Anxiolytics/Hypnotics use within 2 wks before screening are not permitted except for
    •Benzodiazepines of short half life for anxiety/sleeping disorders
    •Zolpidem, zopiclone for insomnia
    •Anticonvulsive therapy (note: neuropathic pain and tremor therapy with anticonvulsants is allowed)
    •Opioids within 2 wks before screening are not permitted
    •Anticholinergics/antihistaminics within 8 weeks before screening are not permitted, except non sedating antihistaminic medications or peripheral anticholinergics without central anticholinergic effects are permitted.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the ADAS-Cog score change from baseline at week 24
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The end of the study will be considered to be the date of the last visit (including the last Follow-up visit) of the last patient in the study.
    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 months8
    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 months8
    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
    patients who need the support of a caregiver or any other responsible person to sign the ICF
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 360
    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)
    -
    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 Decision2009-02-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-04-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-11-19
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