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    Summary
    EudraCT Number:2009-013400-31
    Sponsor's Protocol Code Number:STEADI-09
    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:2010-06-21
    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 number2009-013400-31
    A.3Full title of the trial
    A phase 2, double-blind, placebo-controlled study of the safety and tolerability of etanercept in patients with Alzheimer’s disease
    A.3.2Name or abbreviated title of the trial where available
    Safety and Tolerability of Etanercept in Alzheimer's Disease
    A.4.1Sponsor's protocol code numberSTEADI-09
    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 SponsorUniversity of Southampton
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 Yes
    D.2.1.1.1Trade name Enbrel
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth Europa Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameEnbrel
    D.3.2Product code Not applicable
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEtanercept
    D.3.9.1CAS number 185243-69-0
    D.3.9.2Current sponsor codeNone
    D.3.9.3Other descriptive nameNone
    D.3.10 Strength
    D.3.10.1Concentration unit U/g unit(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.7 x 10^9
    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) Yes
    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 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 placeboPowder for solution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Alzheimer's disease
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    In patients with mild to moderate Alzheimer's disease, is treatment with etanercept, when compared with placebo, safe and well tolerated over a 6-month period?
    E.2.2Secondary objectives of the trial
    The study will also examine the effects of Etanercept in patients with mild to moderate Alzheimer's disease on the following exploratory end-points:

    1. Measures of cognitive function
    2. Measures of the behavioural and psychological symptoms of dementia
    3. Measures of activities of daily living (washing, dressing etc)
    4. Measures of physical frailty
    5. Changes in blood levels of inflammatory markers and peripheral
    immune blood cells, and the relationship of these factors with clinical
    outcome
    6. To establish whether a pro-inflammatory baseline cytokine profile predicts
    better response to treatment with Etanercept.
    7. The influence of the common genetic variant ApoE E4 on the principal
    research question and on the secondary endpoints.
    8. The penetration of Etanercept across the blood brain barrier in
    patients with Alzheimer's disease.
    9. To examine the effects of etanercept on inflammat
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Demographic criteria:
    Patients have to meet all of the following criteria at screening to enter the study:
    1. Male or female patients aged > 54 years.
    2. Have a minimum of 7 years of education.
    3. Be able to hear, read, write and perform study neuropsychological tests in English.
    4. Have adequate visual and auditory acuity to allow neuropsychological testing based on the research clinician’s judgement.

    Medical and therapeutic criteria
    All patients selected will have to:
    1. Fulfil DSM-IV-TR criteria for diagnosis of dementia of the Alzheimer type
    2. Have a diagnosis of probable Alzheimer’s Disease (NINCDS-ADRDA criteria) (McKhann et al 1984).
    3. Mini Mental State Examination (MMSE) score < 27 and > 10 points.
    4. To be currently taking and have been taking a cholinesterase inhibitor for a minimum period of 3 months prior to the day of inclusion into the study or to have been not been taking a cholinesterase inhibitor for a minimum period of 3 months prior to the day of inclusion into the study.
    5. Have an informant who spends at least 24 hours per week with the patient and may be a close friend or a neighbour, not necessarily a close relative, spouse, son or daughter. He/she should be the same throughout the study and should be present at all visits. If it becomes necessary, a change of informant can be made but this must be clearly documented.
    E.4Principal exclusion criteria
    Patients meeting any of the following criteria during screening or baseline evaluations will be excluded from the study:

    General criteria
    1. Refusal to provide informed consent/assent from all participants.
    2. Absence of informant.
    3. Unlikely to cooperate in the study, not able to attend scheduled examinations and visits, or not able to follow study instructions.
    4. Participation in another study with administration of any investigational drug in the previous 3 months or already enrolled in another study.

    Medical and therapeutic criteria
    1. Parkinson’s Disease, Dementia with Lewy Bodies or clinically significant Parkinsonian symptoms.
    2. Vascular disorder (modified Hachinski Ischaemic Scale score > 4)
    3. Recent Transient Ischaemic Attack (TIA) – within the last 3 months
    4. Signs of major cerebrovascular disease on MRI or CT scan, if performed prior to entry into study (i.e. presence of infarction in greater than 25% of white matter, more than 1 lacune within basal ganglia, more than 2 lacunes in white matter).
    5. Any other previous or ongoing chronic or recurrent disease of the central nervous system, including demyelinating disease or psychiatric diseases, that may have an impact on cognitive performance, left to the research clinician’s judgement.
    6. Any of the following laboratory abnormalities at the screening visit:
    i) Clinically significant Vitamin B12 levels less than the lower limit of normal
    ii) Clinically significant folate levels less than the lower limit of normal
    iii) Clinically significant thyroid-stimulating hormone (TSH) levels greater than the upper limit of normal and a clinically significant free thyroxine (FT4)level lower than the lower limit of normal
    7. Patients with previous or present history of severe or unstable medical conditions (e.g. hypertension, diabetes left to the research clinician’s judgement).
    8. Current alcohol >35 units per week for men, or >28 units per week for women, or drug abuse at the discretion of the research clinician.
    9. Surgical intervention planned during the study period.
    10. Treatment with immunosuppressive drugs and/or oral prednisolone greater than 10mg/day within the past 90 days.
    11. Treatment with Memantine within the past 3 months
    12. Vaccination or immunization with any live vaccine (eg: polio, rubella, yellow fever) or the pneumococcal vaccine within the past 30 days.
    13. Pregnancy or breast feeding.
    14. Severe hepatic, renal or cardiac disease.
    15. Previous use of a TNFα agent.
    16. Known skin photosensitivity.
    17. Infection in past 4 weeks or active infection.
    18. Heart failure: New York Heart Association (NYHA) Grade 3-4.
    19. History of blood disorders or current WCC ≤ 3.5 x 109/l; platelet count ≤ 100x109/l ; Hb ≤ 10g/dl.
    20. Active or latent tuberculosis.
    21. Rheumatoid arthritis; psoriasis; psoriatic arthritis or anklylosing spondylitis.
    22. Septic arthritis in past 12 months
    23. Sepsis of prosthesis in past 12 months
    24. Chronic leg ulcers
    25. Indwelling urinary catheter
    26. Pulmonary fibrosis
    27. History of neoplasms / malignancies in past 5 years
    28. Pre-malignant conditions including Barrett’s oesophagus; cervical dysplasia; large bowel polyps
    29. Any relevant acute or chronic abnormality detected during the physical and neurological examinations. ECG or laboratory tests likely to interfere with the study evaluations in the research clinician’s judgement.
    30. Previous exposure to amyloid vaccines, monoclonal antibodies or intravenous immunoglobulins meant to treat Alzheimer’s disease.
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability data, specifically the number and nature of Adverse Events.
    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 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 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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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
    The data collection for the trial will end with the last visit of the last participant 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 months0
    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 months9
    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 Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    No treatment will be available after the trial.
    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 Decision2010-08-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-08-30
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