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    Summary
    EudraCT Number:2009-011172-30
    Sponsor's Protocol Code Number:A9951007
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-06-01
    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 ConcernedSweden - MPA
    A.2EudraCT number2009-011172-30
    A.3Full title of the trial
    A PHASE 2 DOUBLE-BLINDED, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER STUDY EVALUATING THE SAFETY, TOLERABILITY AND PHARMACOKINETICS/ PHARMACODYNAMICS OF PF-04360365 IN MILD TO MODERATE ALZHEIMER’S DISEASE PATIENTS
    A.4.1Sponsor's protocol code numberA9951007
    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 number50
    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 placeboIntravenous 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
    1. To evaluate safety, tolerability and pharmacokinetics of multiple doses of
    PF-04360365 administered monthly (approximately every 30 days; Cohort M) or every 3 months (approximately every 90 days; Cohort Q) for approximately one year in subjects with mild-to-moderate AD.

    2. To assess the effect of multiple doses of PF-04360365 on brain amyloid burden in the subjects dosed monthly (Cohort M) for approximately one year in subjects with mild-to-moderate AD.

    3. To characterize the effect of PF-04360365 on CSF Aβ during dosing for approximately one year.
    E.2.2Secondary objectives of the trial
    1. To examine the efficacy of PF-04360365, as assessed by the 70 point Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-cog), the Disability Assessment for Dementia (DAD) scales, and the Mini Mental State Examination (MMSE) in subjects with mild-to-moderate AD during and following dosing for approximately one year.

    2. To examine the effect of PF-04350365 on plasma Aβ species during and following dosing for approximately one year.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    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 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
    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. Diabetic subjects 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 PI’s medical judgment for diabetics)
    12. 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
    13. Cohort M only - Subjects receiving amyloid imaging (PET) must have measurable amyloid burden on the screening brain PET scan with radiotracer retention in the range expected for AD patients. This will be defined as 3 of the 5 target regions (anterior cingulate, posterior cingulate, frontal cortex, temporal cortex, and parietal cortex) having a ratio of target region radioactivity (kBq/ml) over reference region radioactivity (cerebellar grey matter) >1.5. Subjects that do not have measurable amyloid burden will be excluded
    14. Cohort M only - Subjects with a previous brain PET scan may be eligible to enter the study provided that the subject does not exceed the required local and/or national radiation exposure requirements
    E.4Principal exclusion criteria
    1. Known presenilin mutations
    2. Diagnosis or history of other possible cause for or significant contributor to dementia
    3. Diagnosis or history of cerebrovascular disease, severe carotid stenosis, cerebral hemorrhage, intracranial tumor, subarachnoid hemorrhage, or subdural hematoma that could either contribute to the subject’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 subject’s current cognitive or functional decline, impair their ability to fully participate in the trial or that may impact their status during the one year course of the trial including:
    - Cortical infarct;
    - >2 micro hemorrhages;
    - Strategically located subcortical gray matter infarct
    - Multiple (2 or more) white matter lacunes
    5. History or diagnosis of an underlying hematological disorder causing easy bruising
    6. History or symptoms of a serious autoimmune disorder
    7. History of cancer within the last 5 years
    8. History of clinically significant cardiac arrhythmia or heart block
    9. History or diagnosis of clinically significant ischemic heart disease, congestive heart failure, cardiomyopathy, myocarditis, left ventricular hypertrophy, valvular heart disease
    10. History of clinically significant renal disease
    11. Subjects with uncontrolled hypertension even with therapeutic intervention
    (≥170/100)
    13. History of clinically significant syncope, seizure, head trauma, or clinically significant unexplained loss of consciousness within the last 5 years
    14. A diagnosis of major depressive disorder or other psychiatric illness as the primary diagnosis
    16. Known history of alcohol or drug abuse within 5 years prior to dosing or a positive result as a result of illicit drugs on the drug screening test
    17. History of hospital admission within the last 2 years for asthma, chronic obstructive pulmonary disease, or other chronic respiratory conditions
    18. Known positive HIV status
    19. Subjects who reside in a nursing home or that are inpatients in a hospital; assisted living facilities are permitted
    20. Subjects who are unable to participate in a successful baseline lumbar puncture and sample obtained
    21. Subjects on anticoagulants or aspirin doses >325 mg/day within the last month. Plavix® (clopidogrel bisulfate) or aspirin may be discontinued per the PI’s medical judgment 3 -7 days prior to lumbar puncture
    22. Previous exposure to investigational or non-investigational immune- or biologic therapies for Alzheimer’s disease such as anti-A β antibodies, or β- or gamma-secretase inhibitors.
    23. Known allergy or sensitivity to gadolinium (or similar) contrast agents or PIB ligand that will affect the subject’s participation in this clinical trial or any device/implant/condition that would contraindicate a brain MRI or PET scan.
    24. History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody or IgG-fusion protein.
    25. Medications that may negatively affect cognitive function
    26. Subjects cannot participate in other clinical drug trials for the duration of the study or donate blood within 8 weeks prior to the first infusion and for 6 months after the last administration of study drug.
    27. History of sensitivity to heparin or heparin-induced thrombocytopenia.
    28. Clinically significant laboratory abnormalities
    29. Screening creatinine clearance of <30 mL/min for AD subjects
    30. Active infection with hepatitis B or positive Hepatitis C screening labs.
    31. Positive syphilis test, confirmed
    32. Clinically significant abnormality in the 12-lead ECG
    33. Vitamin B12 levels lower than normal limits (and remains below on repeat testing)
    34. Any other condition that would put the subject at increased safety risk or otherwise make the subject unsuitable for this study
    E.5 End points
    E.5.1Primary end point(s)
    1. Safety endpoints will include adverse events, physical/neurological exams, vital signs, 12-lead ECG, clinical laboratory values (including CSF labs), brain MRI, immunogenicity and cognitive assessments

    2. Change from baseline in amyloid load as assessed by positron emission tomography (PET) imaging at Month 13 in a subset of subjects (Cohort M)

    3. Plasma and CSF concentrations (as available) of PF-04360365

    4. CSF concentrations of Aβ species.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Information not present in EudraCT
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    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 concerned3
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA3
    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 Information not present in EudraCT
    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 years0
    E.8.9.1In the Member State concerned months18
    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 months18
    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) 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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 36
    F.4.2.2In the whole clinical trial 36
    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 Decision2009-07-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-08-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-06-01
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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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