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    Summary
    EudraCT Number:2013-001851-11
    Sponsor's Protocol Code Number:LRP/LND101001/2013/001
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-09-23
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2013-001851-11
    A.3Full title of the trial
    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.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to see how effective and safe two doses of the study drug, LND101001 are compared to a placebo when given to patients with Mild to Moderate Alzheimer’s Disease. A placebo is a dummy medication - looks like the study drug but has no active ingredient.
    A.4.1Sponsor's protocol code numberLRP/LND101001/2013/001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorLupin Limited
    B.1.3.4CountryIndia
    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 supportLupin Limited
    B.4.2CountryIndia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLupin Limited
    B.5.2Functional name of contact pointDr. Narendra Maharaj
    B.5.3 Address:
    B.5.3.1Street AddressLupin Research Park, Survey no 46/47A, Nande Village
    B.5.3.2Town/ cityTaluka Mulshi District Pune
    B.5.3.3Post code412 115
    B.5.3.4CountryIndia
    B.5.4Telephone number+912066749093
    B.5.5Fax number+912066749563
    B.5.6E-mailnarendramaharaj@lupin.com
    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 LND101001
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot Assigned
    D.3.9.2Current sponsor codeLND101001
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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.IMP: 2
    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 LND101001
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot assigned
    D.3.9.2Current sponsor codeLND101001
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 placeboCapsule, soft
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, soft
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Mild to Moderate Alzheimer’s Disease
    E.1.1.1Medical condition in easily understood language
    Mild to Moderate Alzheimer’s Disease/Dementia
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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.
    E.2.2Secondary objectives of the trial
    To evaluate the safety and tolerability of two different doses of LND101001.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female outpatients.
    2. Patients with a diagnosis of dementia of the Alzheimer's type according to the Diagnostic and Statistical Manual, 4th Edition, Text Revision (DSM-IV TR™) criteria and a clinical diagnosis of probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer’s Disease and Related Disorders Association (NINCDS-ADRDA) criteria, 2011 Edition17, of AD and DSM-IV criteria of dementia.
    3. Age of 50 to 85 years.
    4. Brain CT/MRI study to support the clinical diagnosis of AD within the last 12 months prior to the screening visit or during the screening period.
    5. Mild to moderate stage of AD according to a MMSE score of 12 to 22 (inclusive) at the screening visit.
    6. Clinical evidence of cognitive decline in the past 6 months (based on clinical assessments and patient history data, including reports from caregivers).
    7. Patients who are treatment-naïve, have received treatment for AD in the past or currently receiving treatment for AD (in the latter case, Investigators should find it clinically justifiable to switch treatment, and patients should undergo a minimum adequate washout period of 14 days prior to randomization).
    8. The patient, if a female, should:
    ● Have a FSH value indicating menopause with high reliability, AND
    ● Have had her last natural menstruation ≥ 12 (or a different period, depending on region) months prior to the screening visit, OR
    ● Have been surgically sterilized prior to the screening visit, OR
    ● Have had a hysterectomy with oophorectomy prior to the screening visit.
    9. The patient, if a male, should:
    ● Use two methods of contraception in combination; if his female partner is of childbearing potential; e.g., barrier methods such as condom or occlusive cap (diaphragm or cervical/vault cap) with spermicidal foam/gel/film/cream/suppository. (Failure rates indicate that, when used alone, the diaphragm and condom are not highly effective forms of contraception. Therefore, the use of additional spermicides does confer additional theoretical contraceptive protection. However, spermicides alone are inefficient at preventing pregnancy when the whole ejaculate is spilled. Therefore, spermicides are not a barrier method of contraception and should not be used alone.). This combination of contraceptive methods should be used from the baseline visit to ≥ 3 months after the last dose of study medication, OR
    ● Have been surgically sterilized prior to the screening visit.
    ● Should not perform or plan to perform sperm donation from the baseline visit to ≥ 3 months after the last dose of study medication.
    10. Have good general health, hydration and nutrition status for participating in this clinical study, as assessed by the Investigator.
    11. Ability to swallow capsules.
    12. Patient living at home or in long-stay residential or care settings not requiring continuous and extensive nursing care; able to walk independently with or without a walking aid (e.g., cane or walker).
    13. Patient has an identified, reliable caregiver (at least every day for a minimum of 1 to 2 hours) who is 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 the patient’s physical and behavioral symptoms and changes.
    14. The patient and the caregiver are fluent in the language used for administration of the rating scales and cognitive tests and have sufficient visual and hearing skills, and capabilities to perform all the planned assessments.
    15. Willing to adhere to protocol specified requirements.
    16. Signed informed consent by patient (and/or legal representative if applicable) and caregiver prior to the initiation of any study-specific procedures
    E.4Principal exclusion criteria
    1. Clinical, laboratory or neuro-imaging findings (from obligatory brain CT/MRI study within 12 months prior to the screening visit or during the screening period) consistent with
    ●Other primary degenerative dementia, (dementia with Lewy bodies, Parkinson's disease with dementia, frontotemporal dementia, Huntington's disease, Jakob Creutzfeldt disease, Down's syndrome, etc.) and/or vascular dementia.
    ●Other central nervous system lesions (hydrocephalus, severe head trauma, tumors, subdural hematomas or other relevant space occupying processes, etc.).
    ●Other relevant infectious, metabolic or systemic diseases (syphilis, juvenile onset diabetes mellitus, clinically significant vitamin B12, folate or thyroid deficiency, clinically significant serum electrolyte
    disturbances, etc.) affecting central nervous system.
    ●Any other significant brain pathology/condition that can compromise the safety of the patient as determined by the Investigator.
    2. Any current DSM-IV axis I diagnosis other than dementia of the Alzheimer's type, specifically schizophrenia, schizoaffective disorder, bipolar disorders or major depressive disorder.
    3. Patients with major risk of suicidal tendencies and suicide-related behavior, in particular, non-fatal suicide attempt, interrupted attempt, aborted attempt, and preparatory acts or behavior.
    4. The patient has experienced/experiences hallucinations, delusions or any psychotic symptomatology.
    5. The patient has one or more clinical laboratory test values outside the reference range, based on the blood and urine samples taken at the screening visit, that are of potential risk to the patient's safety or the patient has, at the screening visit:
    ●A serum total bilirubin value > 1.5 times the upper limit of normal (ULN).
    ●A serum alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) value > 2 times the ULN.
    ●A serum creatinine > 2 mg/dL and creatinine clearance ≤ 60 mL/min according to Cockcroft-Gault formula.
    6. The patient has, at the screening visit:
    ●An abnormal ECG that is, in the Investigator's opinion, clinically significant.
    ●A PR interval > 250 ms.
    ●A QRS interval > 130 ms (if not caused by a bundle branch block).
    ●A QTcF interval > 450 ms (for males and females) (based on the Fridericia correction where QTcF = QT/RR0.33).
    ●A history of additional risk factors for Torsade de Points (e.g., heart failure, hypokalemia, family history of long QT syndrome).
    7. Any clinically significant, advanced or unstable disease or history of that may interfere with primary or secondary variable evaluations, may bias the assessment of the clinical or mental status of the patient or put the patient at special risk. see protocol for more detail
    8. In the judgment of the Investigator, the patient is not considered to be euthyroid. If the patient has a TSH level outside the laboratory established reference range, reflex test from TSH will be utilized to test for fT4 to support the diagnosis whether the patient is clinically euthyroid. Patients who were previously diagnosed with hyperthyroidism or hypothyroidism and are receiving treatment should
    have been treated with a stable dose of thyroid supplement for at least the past 3 months.
    9. The patient takes or has taken disallowed recent or concomitant medication or started within 6 weeks prior to the randomization visit, or plans to start, non-pharmacologic treatment with potentially significant impact on efficacy parameters within the period specified, or it's anticipated that the patient will require treatment during the study with at least one of the disallowed concomitant medications/treatments during the study.
    10. The patient has clinically significant abnormal vital signs at the screening visit.
    11. Clinical or historical evidence of active hepatitis or positive serology for Hepatitis B or C or HIV.
    12. History of hepatic drug intolerance or any significant drug allergy.
    13. Suspected or known allergy to any components of the study treatments.
    14. Suspected or known history of drug abuse or excessive alcohol intake (as specified in the protocol).
    15. Patient is currently enrolled in, or discontinued 12 weeks prior to screening from, a clinical study or planned participation during this study involving an investigational drug or device, or participate in the off-label use of a drug or device (other than the study medication used in this study), or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
    16. Any condition which in the opinion of the Investigator makes the patient and/or caregiver likely to be non-compliant. Suspected orconfirmed poor compliance, according to Investigator's judgment, in
    completing the study and follow-up (for mental, psychological or social reasons).
    17. Nursing mother or pregnant woman, as verified by a positive pregnancy test.

    See protocol for full exclusion criteria
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint:
    • Mean change from baseline in the ADAS-Cog-13 total score at 90 days.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At day 90
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:
    •Clinical impression of change from baseline for the following secondary efficacy variable between the active study medication groups (LND101001 5 mg, LND101001 25 mg) and placebo:
    ADCS-CGIC at 30, 60 and 90 days

    Mean change from baseline in the following:
    ADAS-Cog-13 total score at 30 and 60 days.
    MMSE at 90 days.
    ADCS-ADL at 30, 60 and 90 days.
    NPI at 90 days.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Various timepoints during the study
    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 Yes
    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 No
    E.7.1.2Bioequivalence study No
    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) 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 Yes
    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.8.2.4Number of treatment arms in the trial3
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA52
    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 No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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 No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 81
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    The protocol and the informed consent form describes the measures to safeguard the vulnerable population.

    Please refer to the protocol sections: 7.2, 12, 9.2.4 and 16.2
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 171
    F.4.2.2In the whole clinical trial 171
    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)
    Patients will receive standard of care as prescribed by treating physician after completion of study participation.
    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 Decision2013-10-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-08-29
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