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    Summary
    EudraCT Number:2008-000986-42
    Sponsor's Protocol Code Number:A9951002
    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:2008-08-19
    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 number2008-000986-42
    A.3Full title of the trial
    A PHASE 2 MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF MULTIPLE DOSES OF PF-04360365 IN PATIENTS WITH MILD TO MODERATE ALZHEIMER’S DISEASE.
    A.4.1Sponsor's protocol code numberA9951002
    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 SponsorPfizer Inc., 235 East 42nd Street, New York, NY 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 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.3.2Product code PF-04360365
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codePF-04360365
    D.3.9.3Other descriptive nameRN 1219
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeRecombinant humanized monoclonal IgG2∆a antibody
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous 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
    Primary Objectives:

    1. To examine the safety and tolerability of PF-04360365 in subjects with mild-to moderate AD dosed for 18 months and followed for a total of 24 months;

    2. To characterize the pharmacokinetics of PF-04360365 following administration of multiple doses in subjects with mild-to-moderate AD.
    E.2.2Secondary objectives of the trial
    Secondary Objectives:

    1. To examine the efficacy of PF-04360365, as assessed by the 70 point Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-cog) and Disability Assessment for Dementia (DAD) scales, in subjects with mild-to-moderate AD;

    2. To determine the effect of PF-04360365 on the following biochemical markers: Aβ species in CSF and plasma; CSF tau and phosphotau levels;

    3. To examine the effect of PF-04360365 on CSF safety labs in the subset of subjects receiving lumbar punctures;

    4. To determine the immunogenicity of PF-04360365 following repeat dosing;

    5. To evaluate the PK/PD relationships for Aβ biomarkers, ADAS-cog, DAD and AEs of interest.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet the following inclusion criteria to be eligible for study entry:
    1. Males and females (of non-childbearing potential) ages ≥50 years of age at screening;
    2. Diagnosis of probable AD, consistent with criteria from both: • NINCDS-Alzheimer’s Disease and Related Disorders Association (ADRDA); • DSM-IV-TR.
    3. The subject must have a reliable caregiver with contact at least 3 times per week (combination of face to face visits and telephone contact acceptable) who will facilitate the subject’s full participation in the study. Caregivers must have sufficient subject interaction to be able to provide meaningful input into the CDR/CDR-SB, NPI, and DAD.
    4. Subjects and caregivers must be able to read, write, and speak the language in which psychometric tests are provided with acceptable visual and auditory acuity;
    5. MMSE score of 16–26 inclusive at screening;
    6. Rosen-Modified Hachinski Ischemia Score ≤4;
    7. Subjects must be on a stable dose of background cholinesterase inhibitor and/or memantine at least 60 days prior to dosing, with the following caveats: background cholinesterase inhibitor and/or memantine therapy is not required if the subject had previously demonstrated a lack of toleration. Additionally, although strongly encouraged, background therapy is not mandatory for a world region where it is not the standard of care;
    8. Subjects must weigh 35-100 kg.
    9. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) and caregiver have been informed of all pertinent aspects of the trial. Subject must be able to provide assent and assent may be re-evaluated during the study at regular intervals;
    10. Subjects and caregivers are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures;
    11. Women of non child-bearing potential defined as defined in the Lifestyle Guidelines;
    12. Diabetic patients may be included provided that their disease and serum glucose values are controlled and being actively managed, as assessed by the PI using a fasting blood sugar and/or HgA1C (per the PIs medical judgment for diabetics);
    13. In general good health, in the opinion of the Principal Investigator (PI), based on medical history, physical examination, vital signs, 12-lead ECG, and laboratory values, including hematology and chemistry values.
    E.4Principal exclusion criteria
    Subjects who meet any of the following exclusion criteria will be ineligible for study entry.

    Exclusions Related to AD
    1. known presenilin mutations in subject or in the family that may account for dementia.
    2. Diagnosis or history of other possible cause for or significant contributor to dementia,
    3. Diagnosis or history of cerebrovascular, severe carotid stenosis, cerebral hemorrhage, intracranial tumor, subarachnoid hemorrhage, or subdural hematoma that could either contribute to the patient’s current cognitive or functional status, impair their ability to fully participate in the trial or that may impact their status during the two year trial.
    4. Specific exclusionary brain MRI findings that could either contribute to the patient’s current cognitive or functional decline, impair their ability to fully participate in the trial or that may impact their status during the two year course of the trial including:

    Exclusions Related to General Health
    1. Women of childbearing potential.
    2. diagnosis of major depressive disorder or other psychiatric illness as the primary diagnosis.
    3. History or symptoms of autoimmune disorders
    4. History of cancer within the last 5 years (except for cutaneous basal cell, squamous cell cancer resolved by excision, or non-progressive prostate cancer).
    5. History of clinically significant cardiac arrhythmia or heart block
    6. History or diagnosis of clinically significant ischemic heart disease, congestive heart failure, cardiomyopathy, myocarditis, left ventricular hypertrophy, valvular heart disease.
    7. History of clinically significant renal disease
    8. Subjects with uncontrolled hypertension even with therapeutic intervention (≥160/100).
    9. History of clinically significant syncope, seizure, head trauma, or clinically significant unexplained loss of consciousness within the last 5 years.
    10. Known history of alcohol or drug abuse (as defined by the DSM-IV-TR) within
    5 years prior to dosing or a positive result as a result of illicit drugs on the drug +screening test.
    11. Known positive HIV status.
    12. Subjects who reside in a nursing home or that are inpatients in a hospital; assisted living facilities are permitted.

    Exclusions Related to Medications or Procedures
    1. Any contraindications to the MRI procedure based on local operating procedures and instructions.
    2. Previous exposure to investigational or non-investigational immune- or biologic therapies for Alzheimer’s
    3. History of allergic or anaphylactic reaction to any therapeutic or diagnostic
    monoclonal antibody or IgG-fusion protein.
    4. Use of any of the disallowed concomitant medications within the excluded time periods.
    5. Medications that may negatively affect cognitive function
    6. Subjects cannot participate in other clinical drug trials for the duration of the study.
    Subject may not donate blood within 8 weeks prior to the first infusion and for 6 months after the last
    administration of study drug.
    Exclusions Related to Findings on Screening Tests
    1. Clinically significant laboratory abnormalities in the opinion of the investigator or
    Sponsor.
    2. Screening creatinine clearance of <30 mL/min for AD subjects.
    3. Active infection with hepatitis B or C.
    4. Positive syphilis test, confirmed.
    5. A clinically significant (as determined by the PI) abnormality in the 12-lead ECG,
    6. Vitamin B12 levels lower than normal limits (and remains below on repeat testing).
    Subjects may be enrolled following the initiation of B12 therapy for 4 weeks prior to dosing and confirmed within normal limits upon repeat.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoints:

    1. Safety endpoints will include adverse events, physical/neurological exams, vital signs, 12-lead ECG, clinical laboratory values, brain MRI and cognitive assessments;

    2. Plasma and CSF concentrations (as available) of PF-04360365.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability and Immunogenicity
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    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
    dementia of the Alzheimer's type
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 175
    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 Decision2008-09-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-10-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-08-16
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