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    Clinical Trial Results:
    A phase 2, double-blind, placebo-controlled study of the safety and tolerability of etanercept in patients with Alzheimer’s disease

    Summary
    EudraCT number
    		 2009-013400-31
    Trial protocol
    		 GB  
    Global end of trial date
    30 Aug 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Aug 2020
    First version publication date
    15 Aug 2020
    Other versions
    Summary report(s)
    		 Summary

    Trial information

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    Trial identification
    Sponsor protocol code
    STEADI-09
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01068353
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Southampton
    Sponsor organisation address
    University Rd , Southampton , United Kingdom, SO17 1BJ
    Public contact
    Clive Holmes, University of Southampton, c.holmes@soton.ac.uk
    Scientific contact
    Clive Holmes, University of Southampton, c.holmes@soton.ac.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Aug 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Aug 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Aug 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main 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?
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Jan 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 41
    Worldwide total number of subjects
    41
    EEA total number of subjects
    41
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    41
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The protocol and consent forms were approved by a multicenter research ethics committee (Southampton and South West Hampshire REC [A], reference number 10/H0502).

    Pre-assignment
    Screening details
    		 All participants provided informed consent before screening procedures.

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Etanercept
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Etanercept
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    50 mg once weekly for 24 weeks

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate for solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo once weekly for 24 weeks

    Number of subjects in period 1
    		Etanercept Placebo
    Started
    20
    21
    Completed
    18
    15
    Not completed
    2
    6
         Consent withdrawn by subject
    1
    1
         Adverse event, non-fatal
    1
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Etanercept
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Etanercept Placebo Total
    Number of subjects
    		 20 21 41
    Age categorical
    Units: Subjects
        From 65-84 years
    		 20 21 41
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 72 ± 2.1 72.9 ± 2.2 -
    Gender categorical
    Units: Subjects
        Female
    		 5 11 16
        Male
    		 15 10 25
    ADAS-cog 5 Alzheimer’s Disease Assessment Scale–cognitive
    Units: score
        arithmetic mean (standard deviation)
    		 25.8 ± 2.9 25.7 ± 2.5 -

    End points

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    End points reporting groups
    Reporting group title
    Etanercept
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Changes in sMMSE 5 standardized Mini-Mental State Examinationscores compare the baseline to 12 weeks and 24 weeks

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    End point title
    		 Changes in sMMSE 5 standardized Mini-Mental State Examinationscores compare the baseline to 12 weeks and 24 weeks
    End point description
    End point type
    Primary
    End point timeframe
    24 weeks
    End point values
    		 Etanercept Placebo
    Number of subjects analysed
    18
    15
    Units: score
        arithmetic mean (standard error)
    -0.1 ± 0.5
    -1.9 ± 1.2
    Statistical analysis title
    		 sMME
    Comparison groups
    Etanercept v Placebo
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.07
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    24 weeks
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Etanercept
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 Etanercept Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 21 (4.76%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Renal and urinary disorders
    Urinary tract infection
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Etanercept Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 20 (100.00%)
    21 / 21 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    2
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 21 (4.76%)
         occurrences all number
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Yawning
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 21 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    Sleep disorder
         subjects affected / exposed
    3 / 20 (15.00%)
    5 / 21 (23.81%)
         occurrences all number
    3
    6
    Investigations
    Gastroenteritis
         subjects affected / exposed
    9 / 20 (45.00%)
    6 / 21 (28.57%)
         occurrences all number
    11
    7
    Cardiac disorders
    Arterial disorder
         subjects affected / exposed
    2 / 20 (10.00%)
    2 / 21 (9.52%)
         occurrences all number
    2
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 20 (10.00%)
    2 / 21 (9.52%)
         occurrences all number
    2
    2
    Blood and lymphatic system disorders
    Normocytic anaemia
         subjects affected / exposed
    0 / 20 (0.00%)
    3 / 21 (14.29%)
         occurrences all number
    0
    3
    Ear and labyrinth disorders
    Deafness
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 21 (4.76%)
         occurrences all number
    0
    2
    Eye disorders
    Pain
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 21 (9.52%)
         occurrences all number
    0
    2
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    5 / 20 (25.00%)
    5 / 21 (23.81%)
         occurrences all number
    5
    7
    Skin and subcutaneous tissue disorders
    Dermatitis
         subjects affected / exposed
    1 / 20 (5.00%)
    3 / 21 (14.29%)
         occurrences all number
    1
    4
    Renal and urinary disorders
    Incontinence
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 21 (4.76%)
         occurrences all number
    1
    1
    Musculoskeletal and connective tissue disorders
    Pain
         subjects affected / exposed
    1 / 20 (5.00%)
    3 / 21 (14.29%)
         occurrences all number
    1
    5
    Infections and infestations
    Local reaction
         subjects affected / exposed
    2 / 20 (10.00%)
    1 / 21 (4.76%)
         occurrences all number
    4
    1
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 21 (4.76%)
         occurrences all number
    2
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/25934853
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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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