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    Clinical Trial Results:
    A Randomized, Double-blind, Placebo-controlled, Parallel Group, Comparative, Multicenter, Phase 2 Clinical Study to Evaluate Efficacy and Safety of Two Doses of LND101001 Monotherapy in Patients with Mild to Moderate Alzheimer’s Disease.

    Summary
    EudraCT number
    		 2013-001851-11
    Trial protocol
    		 GB   CZ   LT   PL   IT   ES   HR  
    Global end of trial date
    29 Aug 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Sep 2017
    First version publication date
    13 Sep 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LRP/LND101001/2013/001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Lupin Limited
    Sponsor organisation address
    Survey no. 46A/47A, Nande Village, Mulshi, Pune, India,
    Public contact
    Dr. Neelam Kardekar, Lupin Limited, neelamkardekar@lupin.com
    Scientific contact
    Dr. Narendra Maharaj, Lupin Limited, narendramaharaj@lupin.com
    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
    29 Aug 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    29 Aug 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    29 Aug 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the efficacy of two different doses of LND101001 in improving cognitive function in patients with dementia of the Alzheimer's type in comparison with placebo, using the Alzheimer's Disease Assessment Scale - Cognitive Subscale - 13 (ADAS Cog-13) total score.
    Protection of trial subjects
    The Guidelines of the World Medical Association Declaration of Helsinki in its revised edition (64th World Medical Association General Assembly, Fortaleza, Brazil, October 2013), the Guidelines of International Conference of Harmonization (ICH) Good Clinical Practice (GCP) (Committee for Proprietary Medicinal Products [CPMP]/ICH/135/95), and the demands of national drug and data protection laws and other applicable regulatory requirements were strictly followed during this study. Each patient had an identified, reliable caregiver who was willing to provide support, ensure compliance, correct storage, preparation and administration of the study medication and ready to accompany the patient to study visits whenever required, as well as to provide information about patient’s physical and behavioral symptoms and changes. Concomitant medication/treatment, which was considered necessary for the patient’s safety and well-being, could be given at the discretion of the Investigator
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    09 Jun 2015
    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
    Poland: 40
    Country: Number of subjects enrolled
    Spain: 28
    Country: Number of subjects enrolled
    United Kingdom: 10
    Country: Number of subjects enrolled
    Croatia: 20
    Country: Number of subjects enrolled
    Czech Republic: 57
    Country: Number of subjects enrolled
    Romania: 22
    Worldwide total number of subjects
    177
    EEA total number of subjects
    177
    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)
    19
    From 65 to 84 years
    155
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Of the 247 patients who were screened for the study, 69 patients failed screening and 177 patients, who met the eligibility criteria were randomized and received at least one dose of investigational product.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LND101001 5 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    LND101001
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Administered once a day everyday for 90 days

    Arm title
    		 LND101001 25 mg
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    LND101001
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Administered once a day everyday for 90 days

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo of LND101001
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Oral use
    Dosage and administration details
    Administered once a day everyday for 90 Days

    Number of subjects in period 1
    		LND101001 5 mg LND101001 25 mg Placebo
    Started
    56
    60
    61
    Completed
    50
    55
    56
    Not completed
    6
    5
    5
         Adverse event, serious fatal
    1
    -
    -
         Consent withdrawn by subject
    3
    3
    1
         Adverse event, non-fatal
    2
    2
    3
         Lost to follow-up
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LND101001 5 mg
    Reporting group description
    		 -

    Reporting group title
    LND101001 25 mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 LND101001 5 mg LND101001 25 mg Placebo Total
    Number of subjects
    		 56 60 61 177
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 6 4 9 19
        From 65-84 years
    		 49 55 51 155
        85 years and over
    		 1 1 1 3
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 73.3 ( 7.87 ) 73.7 ( 6.21 ) 72.5 ( 7.81 ) -
    Gender categorical
    Units: Subjects
        Female
    		 43 35 41 119
        Male
    		 13 25 20 58
    Subject analysis sets

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety population will include all patients who have received at least one dose of study medication.

    Subject analysis set title
    Per Protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Per Protocol (PP) population will include all patients who satisfactorily complete the study and fully comply with the requirements of the protocol.

    Subject analysis sets values
    		 Safety Population Per Protocol
    Number of subjects
    177
    158
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    73.2 ( 7.31 )
    ( )
    Gender categorical
    Units: Subjects
        Female
    119
        Male
    58

    End points

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    End points reporting groups
    Reporting group title
    LND101001 5 mg
    Reporting group description
    		 -

    Reporting group title
    LND101001 25 mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Subject analysis set title
    Safety Population
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety population will include all patients who have received at least one dose of study medication.

    Subject analysis set title
    Per Protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The Per Protocol (PP) population will include all patients who satisfactorily complete the study and fully comply with the requirements of the protocol.

    Primary: Change from Baseline in ADAS-Cog-13 Total Score

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    End point title
    		 Change from Baseline in ADAS-Cog-13 Total Score
    End point description
    End point type
    Primary
    End point timeframe
    Mean change from baseline in the ADAS-Cog-13 total score at 90 days.
    End point values
    		 LND101001 5 mg LND101001 25 mg Placebo
    Number of subjects analysed
    50
    52
    56
    Units: No unit
        arithmetic mean (standard deviation)
    -0.2 ( 5.71 )
    -0.4 ( 4.96 )
    -1.7 ( 5.87 )
    Statistical analysis title
    		 Primary Analysis: LND101001 5mg Vs Placebo
    Comparison groups
    LND101001 5 mg v Placebo
    Number of subjects included in analysis
    106
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.103
    Method
    		 ANCOVA
    Confidence interval
    Statistical analysis title
    		 Primary Analysis: LND101001 25mg Vs Placebo
    Comparison groups
    LND101001 25 mg v Placebo
    Number of subjects included in analysis
    108
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.143
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The period of observation of AEs was from the time when the informed consent form was signed until 30 days after last administration of study medication i.e. Day 90
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    LND101001 5mg
    Reporting group description
    		 -

    Reporting group title
    LND101001 25 mg
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 LND101001 5mg LND101001 25 mg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 56 (5.36%)
    1 / 60 (1.67%)
    1 / 61 (1.64%)
         number of deaths (all causes)
    1
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 60 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 60 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 60 (1.67%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Ventricular septal defect
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 60 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Nervous system disorders
    Cerebral haemorrhage
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 60 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Dysphagia
         subjects affected / exposed
    1 / 56 (1.79%)
    0 / 60 (0.00%)
    0 / 61 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Knee deformity
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 60 (0.00%)
    1 / 61 (1.64%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 LND101001 5mg LND101001 25 mg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    21 / 56 (37.50%)
    20 / 60 (33.33%)
    20 / 61 (32.79%)
    Investigations
    Blood cholesterol increased
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 60 (0.00%)
    0 / 61 (0.00%)
         occurrences all number
    2
    0
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 60 (0.00%)
    2 / 61 (3.28%)
         occurrences all number
    0
    0
    2
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 56 (5.36%)
    2 / 60 (3.33%)
    0 / 61 (0.00%)
         occurrences all number
    4
    2
    0
    Cardiac disorders
    Bradycardia
         subjects affected / exposed
    0 / 56 (0.00%)
    2 / 60 (3.33%)
    0 / 61 (0.00%)
         occurrences all number
    0
    2
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 56 (3.57%)
    2 / 60 (3.33%)
    1 / 61 (1.64%)
         occurrences all number
    2
    3
    1
    Dizziness
         subjects affected / exposed
    0 / 56 (0.00%)
    2 / 60 (3.33%)
    2 / 61 (3.28%)
         occurrences all number
    0
    2
    4
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 56 (3.57%)
    3 / 60 (5.00%)
    0 / 61 (0.00%)
         occurrences all number
    2
    3
    0
    Diarrhoea
         subjects affected / exposed
    0 / 56 (0.00%)
    2 / 60 (3.33%)
    1 / 61 (1.64%)
         occurrences all number
    0
    2
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    2 / 56 (3.57%)
    0 / 60 (0.00%)
    1 / 61 (1.64%)
         occurrences all number
    2
    0
    1
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    2 / 56 (3.57%)
    1 / 60 (1.67%)
    2 / 61 (3.28%)
         occurrences all number
    2
    1
    2
    Urinary tract infection
         subjects affected / exposed
    0 / 56 (0.00%)
    1 / 60 (1.67%)
    3 / 61 (4.92%)
         occurrences all number
    0
    1
    3
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 56 (0.00%)
    0 / 60 (0.00%)
    2 / 61 (3.28%)
         occurrences all number
    0
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Jan 2015
    Protocol was amended to include following substantial changes – • Sponsor changed from fully owned subsidiary (Lupin Atlantis Holdings SA, Switzerland) to its parent company (Lupin Limited, India) • EU Legal representative changed from Lupin (Europe) Limited to Hormosan Pharma GmbH

    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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    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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