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    Summary
    EudraCT Number:2016-001127-32
    Sponsor's Protocol Code Number:ACP-103-032
    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:2016-08-09
    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 number2016-001127-32
    A.3Full title of the trial
    A Double-Blind, Placebo-Controlled Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer’s Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The research study for patients with Alzheimer’s disease to examine the safety and efficacy of Pimavanserin for the treatment of symptoms of agitation and aggression
    A.4.1Sponsor's protocol code numberACP-103-032
    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 pointAD Clinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address3611 Valley Centre Drive, Suite 300
    B.5.3.2Town/ citySan Diego
    B.5.3.3Post codeCA 92130
    B.5.3.4CountryUnited States
    B.5.6E-mailAD_Trial_Info@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
    D.3.2Product code ACP-103
    D.3.4Pharmaceutical form Film-coated 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
    D.3.9.1CAS number 706782-28-7
    D.3.9.2Current sponsor codeACP-103
    D.3.9.3Other descriptive namePIMAVANSERIN TARTRATE
    D.3.9.4EV Substance CodeSUB128275
    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.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 Yes
    D.2.1.1.1Trade name Nuplazid
    D.2.1.1.2Name of the Marketing Authorisation holderAcadia Pharmaceuticals Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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
    D.3.2Product code ACP-103
    D.3.4Pharmaceutical form Film-coated 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
    D.3.9.1CAS number 706782-28-7
    D.3.9.2Current sponsor codeACP-103
    D.3.9.3Other descriptive namePIMAVANSERIN TARTRATE
    D.3.9.4EV Substance CodeSUB128275
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number17
    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 placeboFilm-coated tablet
    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
    Agitation and Aggression in Alzheimer’s
    Disease
    E.1.1.1Medical condition in easily understood language
    Patients with Alzheimer's disease with symptoms that include agitation, aggressive behaviors
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 100000004852
    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 efficacy of pimavanserin compared with placebo in the
    treatment of agitation and aggression after 12 weeks.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of pimavanserin compared with placebo on caregiver burden.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able to understand and provide signed informed consent, and must be able to sign and date a request for medical records and/or subject privacy form if that is necessary (for example, the Health Insurance Portability and Accountability Act [HIPAA] authorization form in the United States).
    - from the subject, if the subject is deemed competent to provide informed consent
    - from the subject’s legally authorized representative with the subject’s assent, if the subject is deemed not competent to
    provide informed consent
    2. Male or female, 50 years of age or older
    3. Has a diagnosis of probable AD according to the National Institute on Aging-Alzheimer’s Association (NIA-AA) guidelines
    4. Meets criteria for agitation according to the International Psychogeriatric Association (IPA) guidelines
    5. Has an MRI or CT scan (brain imaging) taken during or subsequent to diagnosis of AD, or during the screening period (prior to Baseline)
    6. Has a Mini-Mental State Examination (MMSE) score of 5 to 26 (inclusive) at Screening
    7. Has agitation/aggression defined as a Neuropsychiatric Inventory-
    Clinician rating scale (NPI-C) combined agitation and aggression
    domain score of ≥14 at both the Screening and Baseline visits
    8. Lives at home or in an assisted living facility (but can visit the clinic
    as an outpatient). Subjects must have been at their current location
    for at least 3 weeks prior to Screening and plan to remain at the same location for the duration of the trial.
    9. Has a designated study partner/caregiver (e.g., relative, housemate, close personal friend, or professional caregiver) who is in contact with the subject at least 3 times a week on 3 separate days. The
    study partner/caregiver must:
    - be willing and able to accompany the subject to all clinic visits,
    - be capable of routinely monitoring and reporting study drug use,
    - be regarded by the Investigator as sufficiently informed to report accurately on these areas of the subject’s behavioral and functional status.
    10. The subject’s study partner/caregiver provides written agreement that they understand the study, including the role of the study
    partner/caregiver and will participate in the study
    11. Both subject and study partner/caregiver are fluent in and able to read the local language in which study assessments are administered at the clinical site.
    12. Both subject and study partner/caregiver are willing and able to participate in all scheduled evaluations and complete all required tests
    13. If taking antidepressants, has been on a stable dose for at least 4 weeks prior to the Baseline visit and should be expected to remain on a stable dose throughout the trial
    14. If taking cholinesterase inhibitors and/or memantine, has been on a stable dose for at least 12 weeks prior to the Baseline visit and should be expected to remain on a stable dose throughout the trial
    15. If female, 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 (e.g., oral, intrauterine device [IUD;
    diaphragm], injectable, transdermal or implantable contraception) or
    abstinence, for at least one month prior to randomization, during the study, and one month following completion of the study.
    Females of childbearing potential must have a negative serum human
    chorionic gonadotropin (hCG) pregnancy test at Screening and a negative urine hCG pregnancy test at Baseline
    E.4Principal exclusion criteria
    1. The agitation/aggression is attributable to concomitant medications, environmental conditions, substance abuse, or active medical or psychiatric condition
    2. Has a current major depressive disorder episode (within 3 months)
    according to the Diagnostic and Statistical Manual of Mental
    Disorders - Fifth Edition (DSM-5) criteria
    3. Treatment with an antipsychotic medication within 2 weeks of
    Baseline visit or 5 half-lives, whichever is longer
    Investigators should not withdraw a subject’s prohibited medication
    for the purpose of enrolling them into the study unless discontinuation of the medication is deemed to be clinically
    appropriate (e.g., symptoms are not well-controlled or the subject
    cannot tolerate the current medication).
    4. Has brain abnormalities seen on an MRI or CT scan (brain imaging) taken
    during or subsequent to diagnosis of AD, that can be attributed to diseases or processes other than AD, including but not limited to:
    - multiple lacunar infarcts or evidence of a single prior infarct >1 cm3;
    - intracranial mass lesion (including but not limited to meningioma
    [>1 cm3 with evidence of peritumoral edema]); or
    - glioma, vascular malformation, or macrohemorrhage.
    5. Subject or study partner/caregiver has medical condition (e.g., hearing, vision impairments) that would impair the ability to perform the study assessments
    6. Subject requires treatment with a medication prohibited by the
    protocol (see Section 5.7, Appendix C, and Appendix D)
    7. Subject has had a myocardial infarction within the last 6 months prior to Screening
    8. Subject has a known history or symptoms of long QT syndrome
    9. Subject has a QRS interval <120 msec and whose Fridericia’s corrected QT interval (QTcF) is >460 msec at screening OR subject has a QRS interval ≥120 msec and QTcF is >480 msec at screening
    10. Has clinically significant laboratory abnormalities that in the judgment of the Investigator or Medical Monitor would jeopardize the safe participation of the subject in the study
    11. Has a history of a significant psychotic disorder prior to or concomitant with the diagnosis of Alzheimer’s disease including, but not limited to, schizophrenia or bipolar disorder
    12. Subject is bedridden or has any significant medical condition that is unstable and that would either:
    - place the subject at undue risk from study drug or undergoing study
    procedures; or
    - interfere with the interpretation of safety or efficacy evaluations
    performed during the course of the study
    13. Has participated in or is participating in a clinical trial of any investigational drug, device, or intervention, and within 4 weeks (or five half-lives, whichever is longer) of the Baseline visit
    14. Subject with sensitivity to pimavanserin or its excipients
    15. Subject has previously participated in a clinical study with pimavanserin
    16. Subject is judged by the Investigator or the Medical Monitor to be inappropriate for the study
    E.5 End points
    E.5.1Primary end point(s)
    Change from Baseline to Week 12 in CMAI total score.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    E.5.2Secondary end point(s)
    Change from Baseline to Week 12 in the ZBI total score.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 12
    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 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 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.8.2.4Number of treatment arms in the trial3
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Argentina
    Chile
    France
    Germany
    Spain
    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 years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    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: 108
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 324
    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
    There will be subjects that may be unable to give consent and for those people Sponsor has determined that a LAR is acceptable
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 432
    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)
    Subjects who successfully complete the 12-week treatment period will be eligible to enroll in an open-label safety extension study if they qualify. For subjects who do not enroll in the open-label extension study, the continued treatment will be Standard of Care and any other treatment options deemed appropriate by the physician.
    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 Decision2017-01-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-02-16
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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
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