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    Summary
    EudraCT Number:2010-020008-31
    Sponsor's Protocol Code Number:ACP-103-019
    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:2010-08-05
    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 number2010-020008-31
    A.3Full title of the trial
    A Single center, Double-Blind, Placebo-Controlled Study to Examine the Safety and Efficacy of
    Pimavanserin for the Treatment of Psychosis in Alzheimer’s Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare pimavanserin to placebo to treat psychosis associated with Alzheimer's disease
    A.3.2Name or abbreviated title of the trial where available
    Pimavanserin in ADP
    A.4.1Sponsor's protocol code numberACP-103-019
    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 SponsorACADIA Pharmaceuticals 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 supportACADIA Pharmaceuticals Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationACADIA Pharmaceuticals Inc
    B.5.2Functional name of contact pointVice President, Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address3611 Valley Center Drive, Suite 300
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post codeCA 92130-3331
    B.5.3.4CountryUnited States
    B.5.5Fax number+1858320-8684
    B.5.6E-mailACP-103clintrials@acadia-pharm.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 namepimavanserin tartrate
    D.3.2Product code ACP-103
    D.3.4Pharmaceutical form Tablet
    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 INNPimavanserin tartrate
    D.3.9.2Current sponsor codeACP-103
    D.3.9.3Other descriptive namePIMAVANSERIN TARTRATE
    D.3.9.4EV Substance CodeSUB29937
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboTablet
    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
    Psychosis associated with Alzheimer's disease
    E.1.1.1Medical condition in easily understood language
    Psychosis associated with Alzheimer's disease
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behaviours [F01]
    MedDRA Classification
    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 pimavanserin 40 mg compared with placebo in the treatment of patients with
    Alzheimer’s disease psychosis (ADP).
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of pimavanserin in patients with ADP.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients, 50 years of age or older at baseline, with NINCDS-ADRDA defined possible or probable AD
    2. Have been a nursing home resident for ≥ 2 weeks prior to Screening and ≥ 4 weeks prior to randomization, not bedridden and expected to remain in the facility throughout the study
    3. Have psychotic symptoms that developed after the diagnosis of AD was established. These symptoms must include visual and/or auditory hallucinations, and/or delusions
    4. Patient must have actively experienced and verbally communicated psychotic symptoms during the month prior to the Screening visit (SV1) and weekly during the previous 2 weeks prior to Baseline
    5. In the opinion of the investigator the patient requires treatment for their ADP symptoms as evidenced by, for example: distress in the subject, excess disability not attributable to factors other than psychosis, disruptive behavior, interference with medical, nursing or rehabilitative care, and/or dangerous to self or others
    6. Symptoms must be severe enough at Screening (SV1) and at Baseline to warrant treatment with an antipsychotic agent as documented by Domains A and B of the NPI-NH, and defined as a score of 4 or greater on either the Hallucinations (Frequency x Severity) or Delusions (Frequency x Severity) scales OR a total combined score of 6 or greater
    7. Patients on acetylcholinesterase inhibitor (AChEI) therapy and/or memantine must be receiving stable doses for 3 months prior to the Baseline visit and during the study
    8. Female patients must be of non-childbearing potential (defined as either surgically sterilized or at least 1 year postmenopausal) or must agree to use a clinically acceptable method of contraception (such as oral, intrauterine device [IUD; diaphragm], injectable, transdermal or implantable contraception), for at least one month prior to randomization, during the study, and one month following completion of the study
    9. Willing and able to provide informed consent. If patient is unable to provide written consent due to the severity of dementia, consent must be given by a legally authorized representative
    10. Subject and staff caregiver acting as informant are willing and able to adequately communicate in English for the purposes of the key endpoint assessments by raters
    E.4Principal exclusion criteria
    1. Have psychotic symptoms (hallucinations and delusions) which are likely a part of a toxic, metabolic or infection-induced delirium/encephalopathy, psychosis due to substance abuse, psychosis associated with schizophrenia, bipolar disorder or psychotic depression
    2. The psychotic symptoms occur exclusively during the course of a delirium
    3. Have a history of significant psychotic disorders prior to or concomitantly with the diagnosis of Alzheimer’s disease including, but not limited to, schizophrenia or bipolar disorder
    4. Have a score on the MMSE of < 1 or > 22
    5. Are unable to communicate verbally
    6. Have a history of any condition which may prevent the administration or completion of essential study assessments (e.g. cerebrovascular ischemic syndrome/stroke that impairs their ability to complete the MMSE)
    7. Using any of the medications prohibited or in a manner otherwise restricted as described in Appendix 2 of the clinical protocol (Prohibited and restricted Concomitant Medications)
    8. Current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder, including cancer or malignancies, which would affect the patient’s ability to participate in the study
    9. Patient has had a myocardial infarction in the last six months
    10. Patient has moderate to severe congestive heart failure (New York Heart Association class III or IV as described in Appendix 1 of the clinical protocol)
    11. Known history or symptoms of long QT syndrome
    12. Has a Screening and Baseline ECG with Bazett’s corrected QT interval (QTcB) of greater than 460 msec if male or 470 msec if female
    13. Has clinically significant laboratory abnormalities that in the judgment of the investigator would jeopardize the safe conduct of the study
    14. Patient is pregnant or breastfeeding. Female patients of child-bearing potential must have a negative serum pregnancy test at Screening, and it must be confirmed at Baseline using a dipstick urine pregnancy test
    15. Patient has any surgery planned during the screening, treatment or follow-up periods
    16. Patient is likely to have an allergy or sensitivity to pimavanserin based on known allergies to drugs of the same class
    17. Patient has previously participated in any prior clinical study with pimavanserin, and/or received any other investigational drug within 30 days prior to the Screening Visit
    18. Patient is judged by the investigator to be inappropriate for the study
    E.5 End points
    E.5.1Primary end point(s)
    Key Efficacy Endpoints:
    • NPI-NH psychosis subscale (Delusions + Hallucinations Domains A and B)
    • NPI-NH Agitation/Aggression (Domain C)
    • NPI-NH Sleep/Nighttime Behavior (Domain K)
    • Cohen-Mansfield Agitation Inventory – Short Form (CMAI-SF)
    • Alzheimer’s Disease Cooperative Study- Clinical Global Impression of Change (ADCS-CGIC)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Assessments made at baseline then days 15, 29, 43, 64 and 85
    E.5.2Secondary end point(s)
    Seconday Efficacy Endpoints N/A

    EXPLORATORY Efficacy Endpoints
    • NPI-NH total and all remaining individual behavioral domains
    • Alzheimer’s Disease Cooperative Study – Activities of Daily Living Instrument (ADCS-ADL)
    • Change in utilization of rescue medications for behavioral disturbance and sleep
    • Durability of response to pimavanserin in patients with ADP as measured by change from Day 43 to Day 85
    E.5.2.1Timepoint(s) of evaluation of this end point
    Assessments made at baseline then days 15, 29, 43, 64 and 85
    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 No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    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 years2
    E.8.9.1In the Member State concerned months6
    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 months6
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 192
    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
    If patient is unable to give written consent because of dementia, consent must be given by a legally authorised representative
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state212
    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 Decision2010-08-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-10-27
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