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    Clinical Trial Results:
    A randomized, multicenter, multicountry study to evaluate the effectiveness of Florbetapir (18F) PET imaging in changing patient management and to evaluate the relationship between Florbetapir (18F) PET status and cognitive decline.

    Summary
    EudraCT number
    		 2012-002595-13
    Trial protocol
    		 IT  
    Global end of trial date
    02 Apr 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    29 Apr 2016
    First version publication date
    29 Apr 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    18F-AV-45-A18
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01703702
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Avid Radiopharmaceuticals, Inc.
    Sponsor organisation address
    3711 Market St., Philadelphia, United States, 19104
    Public contact
    Clinical Operations, Avid Radiopharmaceuticals, 1 215 2980700,
    Scientific contact
    Chief Medical Officer, Avid Radiopharmaceuticals, 1 215 2980700,
    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
    02 Apr 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Apr 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Apr 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Patient Management: To evaluate the effectiveness of florbetapir (18F) PET imaging in changing patient management, as defined by the treating physician. Change in management will be determined by comparing the intended management (pre-scan) to the observed management (during the 3 months following the scan). Patient Prognosis: To evaluate the association between scan status and cognitive decline as measured by Alzheimer's Disease Assessment Scale —Cognitive subscale (ADAS-cog) in study patients with mild impairment of cognition .
    Protection of trial subjects
    Subjects who received florbetapir (18F) were closely followed by means of adverse event reporting and vital signs. In the event of a study related adverse event, subjects would not have been discharged until the event had resolved or stabilized. Subjects were made aware of the planned procedures and their comfort in the scanner was maximized to minimize the risk of any discomfort while in the PET scanner.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Nov 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 178
    Country: Number of subjects enrolled
    Italy: 231
    Country: Number of subjects enrolled
    United States: 232
    Worldwide total number of subjects
    641
    EEA total number of subjects
    409
    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)
    100
    From 65 to 84 years
    502
    85 years and over
    39

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 641 patients were enrolled in the study. 21 of these subjects did not receive florbetapir (18F). 620 patients received florbetapir (18F) and comprise the Safety Population. Of the patients who received florbetapir (18F), 2 patients did not have a successful PET scan. The remaining 618 patients comprise the Efficacy Population.

    Pre-assignment period milestones
    Number of subjects started
    		 641
    Intermediate milestone: Number of subjects
    Safety Population: 620
    Number of subjects completed
    		 618

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Consent withdrawn by subject: 5
    Reason: Number of subjects
    		 Hospitalized for pneumonia: 1
    Reason: Number of subjects
    		 Diagnosed with lung cancer: 1
    Reason: Number of subjects
    		 Death: 1
    Reason: Number of subjects
    		 Food allergic reaction: 1
    Reason: Number of subjects
    		 Consent withdrawn: 9
    Reason: Number of subjects
    		 Subject decided to stop the study: 1
    Reason: Number of subjects
    		 Caregiver not able to accompany patient: 1
    Reason: Number of subjects
    		 Unable to complete PET scan: 2
    Reason: Number of subjects
    		 Hospitalized for seizures: 1
    Period 1
    Period 1 title
    Efficacy Population (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind [1]
    Roles blinded
    		 Subject, Investigator, Carer, Assessor
    Blinding implementation details
    All patients received florbetapir (18F). Interventional group: the treating physician, patient, and caregiver were informed of the florbetapir (18F) PET scan results. Control group: the treating physician, patient, and caregiver were blinded to the florbetapir (18F) PET scan result for a period of 12 months. Raters administering the ADAS-Cog were blinded to PET scan results for all patients. Physicians who interpreted the PET scans were blinded to all other clinical information.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Interventional
    Arm description
    		 The treating physician, patient and caregiver were informed of the result of the florbetapir (18F) PET.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Florbetapir (18F)
    Investigational medicinal product code
    18F-AV-45
    Other name
    Amyvid, florbetapir F 18
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received a one-time intravenous (IV) bolus injection of 370 megabecquerels (MBq) florbetapir (18F).

    Arm title
    		 Control
    Arm description
    		 The treating physician, patient and caregiver were blinded the result of the florbetapir (18F) PET scan for a period of 12 months.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Florbetapir (18F)
    Investigational medicinal product code
    18F-AV-45
    Other name
    Amyvid, florbetapir F 18
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Subjects received a one-time intravenous (IV) bolus injection of 370 megabecquerels (MBq) florbetapir (18F).

    Notes
    [1] - The number of roles blinded appears inconsistent with a single blinded trial. It is expected that there will be one role blinded in a single blind trial.
    Justification: Please see the blinding implementation details as the blinding in this study is not related to the typical treatment/placebo paradigm.
    Number of subjects in period 1 [2]
    		Interventional Control
    Started
    308
    310
    Completed
    272
    288
    Not completed
    36
    22
         Caregiver hospitalized, patient institutionalized
    1
    -
         Physical/Cognitive impairment prevent consultation
    1
    -
         Behavioral disturbance
    -
    1
         Administrative Decision
    5
    5
         Patient wanted PET scan results before 12 months
    -
    3
         Patient noncompliant for tests
    1
    -
         Patient moved
    -
    1
         Patient decision
    1
    -
         Consent withdrawn by subject
    13
    5
         Screening failure
    -
    1
         Concurrent motorneuron disease
    1
    -
         Ischemic stroke
    -
    1
         Death
    2
    3
         Broken hip, unable to return for final visit
    -
    1
         Hospitalized on life support
    1
    -
         Lost to follow-up
    4
    1
         Patient erroneously indicated as screen failure
    1
    -
         Inclusion in a clinical trial
    5
    -
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Refer to the pre-assignment period for details on the subjects who enrolled in the study but were not randomized to the baseline Efficacy Population.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Interventional
    Reporting group description
    		 The treating physician, patient and caregiver were informed of the result of the florbetapir (18F) PET.

    Reporting group title
    Control
    Reporting group description
    		 The treating physician, patient and caregiver were blinded the result of the florbetapir (18F) PET scan for a period of 12 months.

    Reporting group values
    		 Interventional Control Total
    Number of subjects
    		 308 310 618
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 73.1 ( 8.2 ) 72.7 ( 7.94 ) -
    Gender categorical
    Units: Subjects
        Female
    		 142 160 302
        Male
    		 166 150 316

    End points

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    End points reporting groups
    Reporting group title
    Interventional
    Reporting group description
    		 The treating physician, patient and caregiver were informed of the result of the florbetapir (18F) PET.

    Reporting group title
    Control
    Reporting group description
    		 The treating physician, patient and caregiver were blinded the result of the florbetapir (18F) PET scan for a period of 12 months.

    Subject analysis set title
    Mild Impairment AB+
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Patients diagnosed with a cognitive status of mild impairment and AB+ scan result.

    Subject analysis set title
    Mild Impairment AB-
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Patients diagnosed with a cognitive status of mild impairment and AB- scan result.

    Subject analysis set title
    Intervention scan/diagnosis discordant
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Intervention arm patients whose florbetapir F18 PET scan results that were not predicted by their baseline clinical diagnosis.

    Subject analysis set title
    Control scan/diagnosis discordant
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Control arm patients whose florbetapir F18 PET scan results that were not predicted by their baseline clinical diagnosis.

    Subject analysis set title
    Intervention scan/diagnosis concordant
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Intervention arm patients whose F18 PET scan results were predicted by their initial diagnosis

    Subject analysis set title
    Control scan/diagnosis concordant
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Control arm patients whose F18 PET scan results were predicted by their initial diagnosis

    Primary: Clinical and Diagnostic Change in Patient Management

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    End point title
    		 Clinical and Diagnostic Change in Patient Management
    End point description
    Comparison of the percentage of patients who have a change in management from baseline to 3 months for patients who receive scan results immediately (intervention arm) and those who receive scan results 12 months later (control arm).
    End point type
    Primary
    End point timeframe
    3 months
    End point values
    		 Interventional Control
    Number of subjects analysed
    300
    299
    Units: percentage of patients
    number (not applicable)
        Change
    68
    55.5
    Statistical analysis title
    		 Primary Objective 1
    Comparison groups
    Control v Interventional
    Number of subjects included in analysis
    599
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.002
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.22
         upper limit
    		 2.38

    Primary: Change in ADAS-Cog 11 Total Score

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    End point title
    		 Change in ADAS-Cog 11 Total Score
    End point description
    Change from baseline in the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) 11 Score in patients with mild impairment by positive or negative florbetapir (18F) PET scan result (Aß+/Aß-).
    End point type
    Primary
    End point timeframe
    12 months
    End point values
    		 Mild Impairment AB+ Mild Impairment AB-
    Number of subjects analysed
    178
    134
    Units: ADAS-Cog 11
    least squares mean (standard error)
        Change from Baseline
    0.95 ( 0.38 )
    1.29 ( 0.43 )
    Statistical analysis title
    		 Primary Objective 2
    Comparison groups
    Mild Impairment AB+ v Mild Impairment AB-
    Number of subjects included in analysis
    312
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.568 [1]
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.54
         upper limit
    		 0.84
    Notes
    [1] - ANCOVA adjusted for confounding factors: Baseline ADAS-Cog score, study arm, Alzheimer's treatment, country, and interaction between study arm and Alzheimer's treatment.

    Secondary: Change in Patient's Clinical Diagnosis

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    End point title
    		 Change in Patient's Clinical Diagnosis
    End point description
    Comparison of the percentage of patients who have a change in diagnosis from baseline to 3 months for patients in the intervention and control arms for whom the scan result was not predicted by the initial diagnosis.
    End point type
    Secondary
    End point timeframe
    3 months
    End point values
    		 Intervention scan/diagnosis discordant Control scan/diagnosis discordant
    Number of subjects analysed
    111
    109
    Units: percentage of patients
    number (not applicable)
        Change
    85.6
    11.9
    Statistical analysis title
    		 Secondary Objective 1
    Comparison groups
    Intervention scan/diagnosis discordant v Control scan/diagnosis discordant
    Number of subjects included in analysis
    220
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    43.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 20
         upper limit
    		 96.12

    Secondary: Change in Diagnostic Confidence

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    End point title
    		 Change in Diagnostic Confidence
    End point description
    Comparison of the percentage point change in the physician's diagnostic confidence from baseline to month 3 in the intervention and control arms for patients whose scan result was predicted by their baseline clinical diagnosis.
    End point type
    Secondary
    End point timeframe
    3 months
    End point values
    		 Intervention scan/diagnosis concordant Control scan/diagnosis concordant
    Number of subjects analysed
    189
    190
    Units: Percentage Point
    least squares mean (standard error)
        Change
    23.54 ( 1.13 )
    2.85 ( 1.15 )
    Statistical analysis title
    		 Secondary Objective 2
    Comparison groups
    Intervention scan/diagnosis concordant v Control scan/diagnosis concordant
    Number of subjects included in analysis
    379
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    20.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 18.95
         upper limit
    		 22.43

    Secondary: Change in Patient Management: Advice/Counseling

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    End point title
    		 Change in Patient Management: Advice/Counseling
    End point description
    Comparison of the percentage of patients in the intervention and control arms who have a change in management relating to advice and counseling from baseline to 3 months.
    End point type
    Secondary
    End point timeframe
    3 months
    End point values
    		 Interventional Control
    Number of subjects analysed
    300
    299
    Units: percentage of patients
    number (not applicable)
        Change
    64.7
    58.9
    Statistical analysis title
    		 Secondary Objective 3
    Comparison groups
    Control v Interventional
    Number of subjects included in analysis
    599
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.144
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.78

    Secondary: Change in Caregiver Self-efficacy

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    End point title
    		 Change in Caregiver Self-efficacy
    End point description
    Comparison of the change in self-efficacy between intervention and control arms. Change in self-efficacy is defined as the difference between total score on the Fortinsky: Family caregivers’ self-efficacy for managing dementia scale at Follow-up (3 months) and baseline.
    End point type
    Secondary
    End point timeframe
    3 months
    End point values
    		 Interventional Control
    Number of subjects analysed
    301
    297
    Units: score
    least squares mean (standard error)
        Change
    0.16 ( 1.24 )
    0 ( 1.26 )
    Statistical analysis title
    		 Secondary Objective 4
    Comparison groups
    Interventional v Control
    Number of subjects included in analysis
    598
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.925
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    0.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.2
         upper limit
    		 3.53

    Secondary: Change in Patient Management: Individual Categories

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    End point title
    		 Change in Patient Management: Individual Categories
    End point description
    Compare the percentage of patients with a change from baseline in the individual patient management categories at 3 months in the interventional and control arms.The individual categories are: Major diagnostic tests, Alzheimer’s/cognition medication, neuropsychological tests, physician follow-up for re-evaluation or specialist referral.
    End point type
    Secondary
    End point timeframe
    3 months
    End point values
    		 Interventional Control
    Number of subjects analysed
    300
    299
    Units: percentage of patients
    number (not applicable)
        Major Diagnostic Tests
    21
    20.4
        Alzheimer's/Cognitive Medication
    35.7
    22.1
        Neuropsychological Tests
    14.7
    9.7
        Physician Follow-up for Re-evaluation
    15
    14
        Specialist Referral
    30.7
    23.4
    Statistical analysis title
    		 Major Diagnostic Tests
    Comparison groups
    Interventional v Control
    Number of subjects included in analysis
    599
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.857
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 1.54
    Statistical analysis title
    		 Alzheimer's/Cognitive Medication
    Comparison groups
    Interventional v Control
    Number of subjects included in analysis
    599
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.36
         upper limit
    		 2.81
    Statistical analysis title
    		 Neuropsychological Tests
    Comparison groups
    Interventional v Control
    Number of subjects included in analysis
    599
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.063
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 2.64
    Statistical analysis title
    		 Physician Follow-up for Re-evaluation
    Comparison groups
    Interventional v Control
    Number of subjects included in analysis
    599
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.741
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 1.7
    Statistical analysis title
    		 Specialist Referral
    Comparison groups
    Interventional v Control
    Number of subjects included in analysis
    599
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.046
    Method
    		 Chi-squared
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.01
         upper limit
    		 2.08

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    48 hours post-injection
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Safety Population
    Reporting group description
    		 All subjects

    Serious adverse events
    		 Safety Population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 620 (0.32%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Subdural haematoma
         subjects affected / exposed
    1 / 620 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 620 (0.16%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Safety Population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    36 / 620 (5.81%)
    Injury, poisoning and procedural complications
    Post procedural haematoma
         subjects affected / exposed
    1 / 620 (0.16%)
         occurrences all number
    1
    Vascular disorders
    Flushing
         subjects affected / exposed
    1 / 620 (0.16%)
         occurrences all number
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 620 (0.16%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    17 / 620 (2.74%)
         occurrences all number
    17
    Dizziness
         subjects affected / exposed
    1 / 620 (0.16%)
         occurrences all number
    1
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    3 / 620 (0.48%)
         occurrences all number
    3
    Fatigue
         subjects affected / exposed
    3 / 620 (0.48%)
         occurrences all number
    3
    Feeling abnormal
         subjects affected / exposed
    1 / 620 (0.16%)
         occurrences all number
    1
    Malaise
         subjects affected / exposed
    1 / 620 (0.16%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 620 (0.16%)
         occurrences all number
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    4 / 620 (0.65%)
         occurrences all number
    4
    Abnormal faeces
         subjects affected / exposed
    1 / 620 (0.16%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    1 / 620 (0.16%)
         occurrences all number
    1
    Psychiatric disorders
    Confusional state
         subjects affected / exposed
    1 / 620 (0.16%)
         occurrences all number
    1
    Hallucination, olfactory
         subjects affected / exposed
    1 / 620 (0.16%)
         occurrences all number
    1
    Insomnia
         subjects affected / exposed
    1 / 620 (0.16%)
         occurrences all number
    1
    Irritability
         subjects affected / exposed
    1 / 620 (0.16%)
         occurrences all number
    1
    Sleep disorder
         subjects affected / exposed
    1 / 620 (0.16%)
         occurrences all number
    1
    Renal and urinary disorders
    Dysuria
         subjects affected / exposed
    1 / 620 (0.16%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    1 / 620 (0.16%)
         occurrences all number
    1
    Myalgia
         subjects affected / exposed
    1 / 620 (0.16%)
         occurrences all number
    1
    Infections and infestations
    Upper Respiratory Tract Infection
         subjects affected / exposed
    1 / 620 (0.16%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Aug 2013
    The primary purpose of amendment 1 was to group all objectives determined at the 3 month time point as secondary objectives, to remove QoL-AD as an assessment for patient's caregivers because it is a measure for patients, and to restructure the 12 month visit to include a pre-visit and a clinic visit.

    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
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