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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2014-000830-42
    Sponsor's Protocol Code Number:B2081011
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-07-08
    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 number2014-000830-42
    A.3Full title of the trial
    A Randomized, 18-Week, Placebo Controlled, Double Blind, Parallel Group Study of the Safety and Efficacy of PF-05212377 (SAM-760) in Subjects with Mild to Moderate Alzheimer's Disease with Existing Neuropsychiatric Symptoms on a Stable Daily Dose of Donepezil.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to test whether PF-05212377 is safe and improves symptoms in patients with Alzheimer's disease with existing neuropsychiatric symptoms.
    A.3.2Name or abbreviated title of the trial where available
    SAM-760
    A.4.1Sponsor's protocol code numberB2081011
    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 SponsorPfizer Inc. 235 East 42nd Street, New York, 10017
    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 supportPfizer Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018007181021
    B.5.5Fax number0013037391119
    B.5.6E-mailclinicaltrials.gov_inquiries@pfizer.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.3.2Product code PF-05212377 (SAM-760)
    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 INNPF-05212377
    D.3.9.3Other descriptive nameSAM-760
    D.3.9.4EV Substance CodeSUB30681
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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-to-Moderate Alzheimer's Disease with extising Nueropsychiatric Symptoms
    E.1.1.1Medical condition in easily understood language
    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 18.0
    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 PF-05212377 (SAM-760) 30 mg QD as compared to placebo on the primary measure of cognition and memory, the Alzheimer’s Disease Assessment Scale – cognitive subscale (13 item; ADAS-cog13) 12 weeks after start of double-blind study medication.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy of PF-05212377 (SAM-760) 30 mg QD as compared to placebo on a broad measure of behavior, the Neuropsychiatric Inventory (12 item) (NPI) at 12 weeks after start of double-blind study medication.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subject eligibility should be reviewed and documented by an appropriately qualified member
    of the investigator’s study team before subjects are included in the study.

    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:

    1. Evidence of a personally signed and dated informed consent document indicating that the subject (and/or a legal representative) has been informed of all pertinent aspects of the study. Subject caregiver must also consent to participate in the study. If the subject lacks sufficient decision-making capacity, in the opinion of the investigator (with appropriate documentation of such), a mentally-competent legal representative must provide informed consent on his/her behalf, and the subject must provide verbal or written assent.

    2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

    3. Men and women of non-childbearing potential ≥60 years of age.
    Since women are over the age of 60, they are considered post-menopausal and therefore of non-child bearing potential (WONCBP).
    If male, either a) of reproductive potential and compliant in using adequate birth control or are b) not of reproductive potential. Surgical sterilization must be documented. Adequate birth control for males is defined as a condom and spermicidal gel or foam, or abstinence, defined as no intercourse with any female of child bearing potential throughout the duration of the study, which is any female not meeting above definition for non-child bearing potential.

    4. Diagnosis of probable AD (with appropriate documentation of supporting data) according to the following criteria:
    a. Diagnostic and Statistical Manual of Mental Disorders-IV Text Revision (DSM-IV-TR);
    b. National Institute of Neurological and Communicative Disorders and Stroke – Alzheimer’s Disease and Related Disorder Association’s Criteria
    (NINCDS-ADRDA) for probable AD;
    c. MMSE score between 10 and 24, inclusive, at Screen and Visit 1;
    d. Modified Hachinski Ischemic Score ≤ 4.

    5. Have existing neuropsychiatric symptoms as defined by a score ≥10 on the NPI at screening, arising from item scores of ≥2 (frequency X severity) on at least 2 domains.

    6. Have had brain imaging such as magnetic resonance imaging (MRI) or CT scan within 12 months of screening consistent with a diagnosis of probable AD without any other clinically significant co-morbid pathologies found. If there has been a
    significant change in clinical status suggestive of stroke or other possible neurological disease with onset between the time of the last MRI or CT (if applicable) and the Screening evaluation, an MRI or CT scan may be obtained at screening if considered
    appropriate by the investigator.

    7. Have been taking donepezil at a stable dose of 5 mg or 10 mg at a stable formulation, for at least four months prior to Visit 1, with no intent to change such for the duration of the study (unless medically indicated and unexpected). Subjects not currently on
    donepezil can be started on donepezil and stabilized for 4 months prior to Visit 1. The Sponsor may provide financial support for background donepezil therapy, on request, on a case by case basis.

    8. If taking antidepressants, must be on a stable dose and regimen for at least 30 days prior to the Screening visit and for the duration of the study.

    9. Have at least eight years of prior education and should have previously (in pre-AD condition) been capable of reading, writing, and communicating effectively with others.

    10. Have a caregiver who assists (or directly supervises) the subject and has intimate knowledge of the subject’s cognitive, functional, and emotional states, and of the subject’s personal care, such that he/she can act as an adequate informant, as judged
    by the investigator. The caregiver must be willing to accompany the subject to all study visits, and must be willing to oversee study drug administration and study diary completion. The caregiver should have a minimum of 3 hours direct contact with the subject at least 5 days per week. The caregiver must also be willing and able to give informed consent, be able to read and write, and be capable of providing informed
    responses to the NPI, CSDD, and ADCS-ADL assessment tools.

    11. Is community dwelling or living in an assisted care facility if living independently without the need for 24 hour direct care.
    E.4Principal exclusion criteria
    1. Subjects who are investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
    2. Demonstrate extreme agitation, physical aggression or violence to themselves, their caregiver, or others, or who have a severity of behavioral disturbance at screening that would compromise the assessment of cognition, based on the opinion of the
    investigator and/or an inability to complete the ADAS-cog assessment at Screening.
    3. Have major structural brain disease (eg, ischemic infarcts, subdural hematoma, hemorrhage, hydrocephalus, brain tumors, multiple subcortical ischemic lesions, or a single lesion in a critical region [eg, thalamus, hippocampus], or a degree of white matter disease sufficient to call into question the diagnosis of primary AD vs. vascular dementia).
    4. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study restuls and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

    a. Any physical disability that would prevent completion of study procedures or assessments (eg, blindness or significant visual impairment, deafness or significant hearing impairment not corrected by hearing aids, non AD related speech impairment).

    b. A diagnosis of unstable diabetes mellitus defined as:
    • requiring insulin treatment, except that once daily administration of basal long-acting insulin is acceptable if stable for at least 30 days;
    • HbA1C >8% or fasting serum glucose value >140 mg/dl at Screening (may be repeated once for confirmation).

    c. A history of cancer within five years of enrollment with the exception of non-melanoma skin cancers or prostate cancer that has been stable for at least six
    months or American Joint Committee on Cancer (AJCC) Grade 0 or Grade 1 cancers that have a remote probability of recurrence, in the opinion of the
    investigator, in consultation with the Sponsor;

    d. The following cardiovascular parameters:
    • Hypotension (systolic blood pressure <86 millimeters of mercury [mmHg]) or bradycardia with heart rate less than 50 beats per minute during Screening (based on heart rate value from ECG determined by central ECG vendor) or on more than one occasion within three months prior to enrollment (out of range values may be repeated once for confirmation);
    • Uncontrolled hypertension (documented my medical records) as indicated by a resting systolic blood pressure >170 mmHg or diastolic blood pressure >105 mmHg during Screening or on more than one occasion within three months prior to Screening (out of range values may be repeated once for confirmation);
    • A corrected QT interval by the Fridericia correction formula (QTcF) of greater than 470 milliseconds (msec) based on the ECG report from the central ECG vendor or any other clinically significant abnormality found on an ECG during Screening (may be repeated once);
    • Active cardiovascular disease including any of the following: unstable angina, decompensated congestive heart failure, clinically relevant arrhythmias, recent myocardial infarction, or valve abnormalities. NOTE: A history of these conditions is acceptable, if stable under medical management. Subjects with pacemakers, cardiac stents, and internal defibrillators acceptable if subject is stable and following up with cardiologist as indicated to test pacemaker and/or defibrillator or subjects
    on anticoagulant therapy may be included if stable.

    e. A history of traumatic brain injury or stroke with residual neurological deficit;

    f. A diagnosis of a central nervous system disease other than AD that could complicate the safety and/or efficacy assessments in this study (eg, Parkinson’s
    disease, Huntington’s disease [HD], frontotemporal dementia, multi-infarct dementia, dementia with Lewy bodies, normal pressure hydrocephalus);

    g. A history of epilepsy or seizure disorder requiring ongoing treatment, or any seizure or loss of consciousness within six months prior to enrollment;

    h. Any current psychiatric diagnosis according to DSM-IV-TR that may interfere with the subject’s ability to perform the study and all assessments (eg, alcohol or drug-related abuse or alcohol dependence, or alcohol or drug-related dementia, mental retardation, schizophrenia, bipolar disorder, etc). NOTE: Depression or depressive mood arising in the context of AD are not Exclusion Criteria.

    5. Are pregnant or breastfeeding females.
    6. Reside in a nursing home or assisted care facility with need for 24-hour care and supervision; subject may reside in an assisted living facility or old age home provided continuous direct care is not required and a qualified caregiver is available for co-participation.
    Please see protocol for exclusion criteria 7 to 15.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the change from baseline (Visit 2, Week 4) to 12 weeks after the start of double-blind study medication on the ADAS-cog13 total score (Visit 5, Week 16).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16
    E.5.2Secondary end point(s)
    The secondary endpoint is the change from baseline (Visit 2, Week 4) to 12 weeks after the start of double-blind study medication on the NPI total score (Visit 5, Week 16).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 16
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 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 Yes
    E.8.5.1Number of sites anticipated in the EEA37
    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
    Australia
    Canada
    Chile
    France
    Germany
    Spain
    United Kingdom
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days14
    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: 43
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 247
    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
    If determined that the subject lacks the required decision making capacity to provide informed consent, then the subject’s legally authorized representative
    must provide consent for the subject’s participation.
    F.3.3.7Others No
    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 120
    F.4.2.2In the whole clinical trial 290
    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)
    All subjects enrolled in the study may be offered aftercare following discharge from the study, if indicated. This may include ongoing medication management or other treatment for their AD.
    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 Decision2014-09-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-10-23
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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