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    Summary
    EudraCT Number:2010-022922-34
    Sponsor's Protocol Code Number:3098006
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-12-23
    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 ConcernedFinland - Fimea
    A.2EudraCT number2010-022922-34
    A.3Full title of the trial
    Safety and efficacy of ORM-12741 on cognitive and behavioural symptoms in patients with Alzheimer’s disease: A randomised, double-blind, placebo-controlled, parallel group, multicentre study of 12 weeks
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of ORM-12741 on cognitive and behavioural symptoms such e.g. memory, orientation, learning in patients with Alzheimer’s disease (form of dementia)
    A.3.2Name or abbreviated title of the trial where available
    ALPO
    A.4.1Sponsor's protocol code number3098006
    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 SponsorOrion Corporation Orion Pharma
    B.1.3.4CountryFinland
    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 supportOrion Corporation Orion Pharma
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOrion Corporation Orion Pharma
    B.5.2Functional name of contact pointJutta Hänninen
    B.5.3 Address:
    B.5.3.1Street AddressTengströminkatu 8
    B.5.3.2Town/ cityTurku
    B.5.3.3Post codeFI-20360
    B.5.3.4CountryFinland
    B.5.4Telephone number+358 50 966 7792
    B.5.5Fax number+358 10 426 7487
    B.5.6E-mailclinicaltrials@orionpharma.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.3.1Product nameORM-12741
    D.3.2Product code ORM-12741
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.2Current sponsor codeORM-12741
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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.3.1Product nameORM-12741
    D.3.2Product code ORM-12741
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.2Current sponsor codeORM-12741
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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, hard
    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
    Alzheimer’s disease (AD)
    E.1.1.1Medical condition in easily understood language
    Form of dementia
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10001896
    E.1.2Term Alzheimer's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of the study are to evaluate the safety and tolerability of ORM-12741, and the efficacy of ORM-12741 on cognitive symptoms in patients with Alzheimer’s disease (AD) receiving acetylcholinesterase (AChE) inhibitor therapy.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate the efficacy of ORM-12741 on behavioural symptoms, and plasma trough concentrations of ORM-12741 in patients with AD receiving AChE inhibitor therapy, and to evaluate the effects of ORM-12741 on plasma trough concentrations of the AChE inhibitors.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    An optional, exploratory pharmacogenetic sub-study is part of the main protocol. In the context of the study, the objective is to assess possible genetic factors that influence the absorption, distribution, metabolism, excretion, efficacy, and safety of ORM-12741 or its metabolites or AChE inhibitor treatments.
    E.3Principal inclusion criteria
    Male or female patients with diagnosis of probable AD, written informed consent (IC) obtained from the subject and/or his/her caregiver. The subject must have a history of progressive cognitive deterioration, brain imaging consistent with AD, at least a mild level of behavioural symptoms present with a neuropsychiatric inventory (NPI) score > 15, mini-mental state examination (MMSE) score 12-21 at screening visit and be treated with donepezil, rivastigmine or galantamine for at least 3 months. The subject must be 55-90 years of age and fulfil all of the inclusion criteria and none of the exclusion criteria.
    E.4Principal exclusion criteria
    1. Any other type of dementia than AD.
    2. Modified Hachinski Ischemia Score > 4.
    4. Use of antipsychotics within 2 months prior to screening (even for sleep).
    5. Use of benzodiazepines, other than short acting sleep medication, for night at a maximum of 3 nights/week, within 2 months prior to screening.
    6. Use of any anticholinergic medication within 2 months prior to screening (including those used to treat overactive bladder and tricyclic antidepressants).
    7. Changes in antidepressant dosing during the last 2 months prior to the screening.
    8. Current use of other psychotropic agents, like antiepileptics or opioid analgesics
    9. Myocardial infarction within the past 2 years.
    10. Current or history of malignancy within the past 5 year.
    11. Suicidal ideation in the 6 months before screening or current suicide risk based on the Columbia-Suicide Severity Rating Scale (C-SSRS) (items 4 and 5 exclusionary) or current risk of suicide based on the investigator’s judgement.
    12. Subjects with known or suspected history of alcoholism or drug abuse (within the past 5 years).
    13. Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological or psychiatric disorder or any other major concurrent illness that in the opinion of the investigator would interfere with the interpretation of the study results or constitute a health risk for the patient if he/she takes part in the study.
    14. Specific findings in MRI that might in the opinion of the investigator affect cognitive function such as cortical infarct, micro-haemorrhage, or silent lacuna (≤ 1 cm) in a region known to affect cognition such as the hippocampus of either hemisphere, the head of the left caudate, or the dorsomedial region of the left thalamus. With the exception of neuroanatomical areas defined, a maximum of one “clinically silent” lacunar infarct is permitted provided the maximal diameter in any dimension is ≤ 1 cm detected on both T1 and T2 weighted MRI images or observed on CT scan images. Multiple white matter lesions consistent with leukoaraiosis are not exclusionary in an otherwise eligible subject.
    15. Supine HR > 100 bpm after a 5-minute rest at screening visit.
    16. Supine systolic BP (SPB) > 160 or diastolic BP (DPB) > 100 mmHg after a 5-minute rest at screening visit.
    17. Symptomatic orthostatic hypotension at screening visit.
    18. QTc-Fridericia (QTcF) repeatedly > 450 ms in males or > 470 ms in females at screening visit.
    19. Abnormal thyroid-stimulating hormone (TSH), vitamin B12 or folate serum levels at screening (which can not be corrected with substitute therapy).
    20. Any other abnormal value in laboratory tests, vital signs or ECG which may in the opinion of the investigator interfere with the interpretation of the study results (e.g. affect cognition) or cause a health risk for the patient if he/she takes part in the study.
    21. Female patients of childbearing potential (i.e. menstruating or less than 2 years postmenopausal).
    22. Patients with pre-planned elective surgery.
    23. Known hypersensitivity to the active substance or to any of the excipients of the study drugs.
    24. Blood donation or loss of significant amount of blood within 60 days prior to the screening.
    25. Participation in a drug study within 60 days prior to the screening.
    26. Previous AD immunotherapy treatment.
    27. Patient cannot complete the Cognitive Drug Research Ltd. (CDR) cognitive test battery despite having undergone 2 training sessions.
    28. Subjects who reside in a skilled nursing facility.
    29. The subject is not able to swallow test capsule at screening.
    30. Any other condition that in the opinion of the investigator would interfere with the interpretation of the study results or constitute a health risk for the patient if he/she takes part in the study.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy variables:
    The following cognitive tests will be assessed: the Cognitive Drug Research Ltd. (CDR) cognitive test battery, the Controlled Oral Word Association Test (COWAT) and the Category Fluency Test (CFT).
    Safety variables:
    Safety will be assessed by adverse events (AEs), vital signs, 12-lead electrocardiogram (ECG), physical examination and laboratory safety assessments. Suicidality will be assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The CDR cognitive test will be assessed at screening and baseline. At week 1, 2, 4, 8 and 12 - 1 hour after investigational medicinal product (IMP) administration.
    COWAT and CFT will be assessed at baseline and at week 1, 2, 4, 8 and 12 visits.
    E.5.2Secondary end point(s)
    Efficacy:
    The following behavioural and psychological symptom tests will be assessed: the NPI and the Cornell Scale for Depression in Dementia (CSDD). In addition, the Cognitive Failures Questionnaire (CFQ) and the overall change in subject’s clinical condition by Clinical Global Impression of Change (CGI-C) will be assessed.
    Pharmacokinetic (PK) variables:
    Plasma concentrations of ORM-12741, ORM-13720, ORM-13859, ORM-13861, donepezile, galantamine and rivastigmine will be tabulated.
    Pharmacogenetic (PG) variables:
    All subjects participating in this study will provide a blood sample for extraction of DNA to determine the carrier status for the genes (markers) that have been associated with behavioural and psychological symptoms in AD, or affect the target receptor, and may predict the subject’s response to the study treatment. An additional blood sample for DNA extraction will be taken from those subjects who agree to take part in the optional study-related exploratory PG study.
    Sample collection for exploratory studies:
    Blood samples will be collected for metabolomics studies to allow possible exploratory studies related to the pharmacokinetics, pharmacodynamics, or safety of ORM-12741, its metabolites or AChE inhibitor treatments.
    E.5.2.1Timepoint(s) of evaluation of this end point
    NPI behavioural test will be performed at screening, baseline and at week 4 and 12 visits.
    CSDD and CGI-C test will be performed at baseline and at week 4 and 12 visits.
    CFQ assessed at baseline and week 12 visit.
    PK sampling for determination of ORM-12741, ORM-13720, ORM-13859 and ORM-13861 and AChEI is taken before the morning dose of the IMP on day 1 and at week 1, 2, 4, 8 and 12 visits
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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 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
    Last subject's last visit. A decision to continue the study beyond the time covered by the study protocol must be based on a mutual agreement between the investigator and Orion Pharma
    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 months2
    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 months2
    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.1.2.1Number of subjects for this age range: 99
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 99
    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 No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Patients with AD
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 99
    F.4.2.2In the whole clinical trial 99
    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)
    Provided in the protocol
    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 Decision2011-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-01
    P. End of Trial
    P.End of Trial StatusCompleted
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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