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    Summary
    EudraCT Number:2006-004014-41
    Sponsor's Protocol Code Number:BA1106006
    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:2006-10-03
    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 number2006-004014-41
    A.3Full title of the trial
    A randomised, single-blind, placebo-controlled study to investigate the safety, tolerability, immunogenicity, pharmacokinetics and pharmacodynamics of intravenous infusion of GSK933776A in patients with Alzheimer’s disease
    A.4.1Sponsor's protocol code numberBA1106006
    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 SponsorGlaxoSmithKline Research and Development
    B.1.3.4CountryUnited Kingdom
    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 GSK933776A
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    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 humanised monoclonal 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 placeboInjection*
    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 Alzheimer's disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    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
    To assess the safety and tolerability of GSK933776A after single and multiple dose intravenous administration in patients with Alzheimer’s disease
    E.2.2Secondary objectives of the trial
    • To assess the pharmacokinetics of GSK933776A in plasma after single and multiple dose (3) administration in patients with Alzheimer’s disease.
    • To assess the pharmacodynamic activity effect of GSK933776A on free Abeta42 and total Abeta42 in plasma and CSF after single and multiple dose (3) administration in patients with Alzheimer’s disease.
    • To investigate the ability of GSK933776A to alter the expression of markers previously reported to reflect disease progression or severity in plasma and/or CSF, in response to GSK933776A administration.
    • To identify new biomarkers associated with pharmacodynamic drug response and/or toxicity.
    • To assess the immunogenicity of GSK933776A after single and multiple dose (3) intravenous administration in patients with Alzheimer’s disease.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subject with mild Alzheimer's Disease (AD) with MMSE score 18-26 inclusive at the screening visit.
    2. Age 55 to ≤ 80 years
    3. Females must be post-menopausal (i.e. >24 months without menstrual period) or surgically sterile. Female subjects who have been post-menopausal for < 2 years must undertake pregnancy testing (βhCG) at Visit 1, which must be negative and must use an adequate form of non-hormonal contraceptive (e.g. barrier method).
    4. Males whose partner is of child-bearing potential or have been menopausal for <2 years must use an adequate form of contraception (e.g. barrier method).
    5. Subject has the ability to comply with procedures for cognitive and other testing, including MRI scans, and is fluent in the language used for the administration of the cognitive tests.
    6. Subject lives with (or has substantial periods of contact with) a permanent caregiver who is willing to oversee the subject's compliance with protocol-specified procedures and study medication, and report on subject's status.
    7. Fluency in local language and evidence of adequate pre-morbid intellectual functioning. Subject must have adequate visual and auditory abilities to perform all aspects of the cognitive and functional assessments.
    8. In the opinion of the Investigator, the subject and the caregiver will be compliant and have a high probability of completing the study.
    9. Subject has provided full written informed consent prior to the performance of any protocol-specified procedure.
    10. Caregiver has provided a full written informed consent on his/her own behalf prior to the performance of any protocol-specified procedure.
    E.4Principal exclusion criteria
    1. History and/or evidence of any other central nervous system (CNS) disorder that could be interpreted as a cause of dementia
    2. Hachinski Ischaemia Score >4
    3. Subjects currently living in a nursing home.
    4. Subjects who are unable to provide informed consent due to cognitive status
    5. Screening brain MRI with one or more of the following conditions:
    a) not consistent with AD
    b) has evidence of other CNS conditions listed in criterion 1
    c) shows more than minimal vascular changes
    d) shows more than 3 microhaemorrage lesions
    6. Focal findings on the neurological exam (excluding changes attributable to peripheral injury or AD).
    7. Untreated abnormal result of any of the following tests: vitamin B12, syphilis serology, thyroid stimulating hormone (TSH), where this is thought to be the cause of, or to contribute to the severity of, the subject’s dementia.
    8. Any contraindications to lumbar puncture.
    9. History or evidence of significant psychiatric illness such as schizophrenia or bipolar affective disorder or significant neurological disease other than AD, including epilepsy, that in the opinion of the Investigator may affect cognition or would interfere with participation in the study, or Hamilton Psychiatric Rating Scale for Depression (HAM D) (17 item) score >12.
    10. TIA/stroke in the last 3 years, type 1 or type 2 diabetes mellitus, active cardiovascular disease or other uncontrolled risk factors for stroke.
    11. History or evidence of any significant autoimmune disease or disorder.
    12. History of seizures (excluding febrile seizures in childhood), current blood clotting or bleeding disorder or conditions that predispose to these, current clinically significant systemic illness or significant infection within 30 days (e.g. chronic persistent or acute infection).
    13. Treatment with cholinesterase inhibitors is prohibited unless therapy was instituted at least 3 months prior to the administration of GSK933776A, was at stable dosage in the 2 months preceding, subject is free from any clinically significant side effects attributable to the drug that, in the opinion of the investigator, would preclude participation in the trial and that subject and caregiver agree that, barring unforeseen circumstances, the same regimen will be continued for the duration of the trial.
    14. Subjects who have discontinued cholinesterase inhibitors, memantine, cognitive enhancing agents, or drugs that potentially affect cognition in the 60 days prior to screening.
    15. Unless maintained on a stable dose regimen for at least 30 days prior to screening, any other medications with the potential to affect cognition other than those mentioned in #13.A single dose of a short acting benzodiazepine is allowed at MRI and PET screening provided that the dose is given more than 24 hours before cognitive testing.
    16. Use of drugs with platelet antiaggregant or anti-coagulant properties (excluding the use of aspirin 325 mg/day or less
    18. History of or current chronic use of systemic steroids or other immunosuppressants.
    19. Prior participation in clinical investigations involving therapeutic monoclonal antibodies or proteins derived from monoclonal antibodies or any investigations of treatments or use of experimental medications for AD or any other investigational medication or device within 60 days prior to screening or within 5 half-lives of use of such a medication prior to screening, whichever is longer.
    20. Systolic blood pressure >165 mmHg or diastolic blood pressure >95 mmHg.
    21. Abnormal creatinine (more than 1.5 ULN) or estimated calculated creatinine clearance (less than 30ml/min) or clinically significant abnormalities on screening urinalysis.
    22. Significant abnormalities on haematology screen: clinically significant anaemia (i.e. haemoglobin <11 g/dL for males or <10 g/dL for females), platelet counts below 124 GI/L, INR>2.
    23. Other clinically significant abnormality on physical, neurological, laboratory, EEG or ECG examination (e.g. atrial fibrillation) that could compromise the study or be detrimental to the subject.
    24. ALT, AST, alkaline phosphatase values and total bilirubin values >1.5 times the upper limit of normal.
    25. Contraindications for MRI.
    26. Prior allergic reactions to biological products (vaccines, antibodies) or known hypersensitivity to any of the components of the drug.
    27. Subject is unable (with assistance, if appropriate) to take study medication as prescribed throughout the study, has a history of non-compliance with prescribed medication, or is at risk of non-compliance with study medication or procedures.
    28. Subject or caregiver is an immediate family member or employee of the participating Investigator, any of the participating site staff or GSK staff.
    E.5 End points
    E.5.1Primary end point(s)
    •Adverse events.
    • Changes suggesting potential adverse events detected in the physical and neurological examination, brain MRI, cognitive status, laboratory parameters, ECG and vital signs.
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study Information not present in EudraCT
    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) Yes
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.4Double blind No
    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.8.3 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 concerned4
    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 Information not present in EudraCT
    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
    Last Patient Last Visit
    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 months
    E.8.9.1In the Member State concerned days
    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 Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state122
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 122
    F.4.2.2In the whole clinical trial 122
    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 Decision2006-12-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-12-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-05-30
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