Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT01324518
Status:
COMPLETED
Last Update Posted:
2021-04-28
First Post:
2011-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of ORM-12741 in Patients With Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
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'eventGroups': [{'id': 'EG000', 'title': 'Low Dose of ORM-12741', 'description': 'ORM-12741: 60mg twice a day', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 8, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'High Dose of ORM-12741', 'description': 'ORM-12741: 200mg twice a day', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 14, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo for ORM-12741: Placebo twice a day', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 16, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 6, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 8, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Cholestasis', 'notes': 'Cholestatic syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 33, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 33, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose of ORM-12741', 'description': 'ORM-12741: 60mg twice a day'}, {'id': 'OG001', 'title': 'High Dose of ORM-12741', 'description': 'ORM-12741: 200mg twice a day'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo for ORM-12741: Placebo twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'Adverse events from start of ORM-12741 treatment until end of study visit.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Quality of Episodic Memory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose of ORM-12741', 'description': 'ORM-12741: 60mg twice a day'}, {'id': 'OG001', 'title': 'High Dose of ORM-12741', 'description': 'ORM-12741: 200mg twice a day'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo for ORM-12741: Placebo twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '100.7', 'spread': '92.2', 'groupId': 'OG000'}, {'value': '85.0', 'spread': '59.6', 'groupId': 'OG001'}, {'value': '46.3', 'spread': '62.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'The Cognitive Drug Research (CDR) computerised battery tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning. Quality of Episodic Memory measures the capability of maintaining information in episodic memory and is assessed as the sum of sensitivity indices from 4 memory tasks on the CDR computerised battery tests. 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Quality of Memory is a combination of outcome measures Quality of Working Memory \\& Quality of Episodic Memory. Values are calculated by a computer and higher scores mean better outcome.', 'unitOfMeasure': 'Index score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol population'}, {'type': 'PRIMARY', 'title': 'Speed of Memory', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose of ORM-12741', 'description': 'ORM-12741: 60mg twice a day'}, {'id': 'OG001', 'title': 'High Dose of ORM-12741', 'description': 'ORM-12741: 200mg twice a day'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo for ORM-12741: Placebo twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '8287.8', 'spread': '3898.2', 'groupId': 'OG000'}, {'value': '8930.30', 'spread': '5379.5', 'groupId': 'OG001'}, {'value': '8082.2', 'spread': '4064.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'The Cognitive Drug Research (CDR) computerised battery tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning. Speed of Memory is assessed as the sum of speed measures from 2 memory tasks and 2 recognition tasks on the CDR computerised battery tests. 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Power of attention measures speed and attention and is assessed from 3 attentional tasks on the CDR computerised battery tests. Values are calculated by a computer and higher scores mean better outcome.', 'unitOfMeasure': 'msec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol population'}, {'type': 'PRIMARY', 'title': 'Continuity of Attention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose of ORM-12741', 'description': 'ORM-12741: 60mg twice a day'}, {'id': 'OG001', 'title': 'High Dose of ORM-12741', 'description': 'ORM-12741: 200mg twice a day'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo for ORM-12741: Placebo twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '85.7', 'spread': '11.0', 'groupId': 'OG000'}, {'value': '84.8', 'spread': '15.3', 'groupId': 'OG001'}, {'value': '79.7', 'spread': '21.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'The Cognitive Drug Research (CDR) computerised battery tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning. Continuity of attention measures speed and accuracy and is calculated from 3 attentional tasks on the CDR computerised battery tests. Values are calculated by a computer and higher scores mean better outcome.', 'unitOfMeasure': 'Index score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol population'}, {'type': 'SECONDARY', 'title': 'NPI Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose of ORM-12741', 'description': 'ORM-12741: 60mg twice a day'}, {'id': 'OG001', 'title': 'High Dose of ORM-12741', 'description': 'ORM-12741: 200mg twice a day'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo for ORM-12741: Placebo twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '14.7', 'spread': '9.1', 'groupId': 'OG000'}, {'value': '13.7', 'spread': '8.9', 'groupId': 'OG001'}, {'value': '20.2', 'spread': '19.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'The total score of Neuropsychiatric Inventory (NPI) was assessed by a caregiver interview. 10 behavioral areas were included: Delusions, Hallucinations, Agitation/Aggression, Depression/Dysphoria, Anxiety, Elation/Euphoria, Apathy/Indifference, Disinhibition, Irritability/Lability, and Aberrant Motor Behaviour. Higher scores mean worse outcome. Minimum value 0, maximum value 120.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol population'}, {'type': 'SECONDARY', 'title': 'Caregiver Distress Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose of ORM-12741', 'description': 'ORM-12741: 60mg twice a day'}, {'id': 'OG001', 'title': 'High Dose of ORM-12741', 'description': 'ORM-12741: 200mg twice a day'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo for ORM-12741: Placebo twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '4.3', 'groupId': 'OG001'}, {'value': '11.0', 'spread': '10.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'Caregiver distress score generated by adding together the scores of individual NPI distress questions of Neuropsychiatric Inventory NPI. Higher scores mean worse outcome. Minimum value 0, maximum value 120.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'per protocol population'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics of ORM-12741', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose of ORM-12741', 'description': 'ORM-12741: 60mg twice a day'}, {'id': 'OG001', 'title': 'High Dose of ORM-12741', 'description': 'ORM-12741: 200mg twice a day'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo for ORM-12741: Placebo twice a day'}], 'classes': [{'categories': [{'measurements': [{'value': '18.4', 'spread': '13.9', 'groupId': 'OG000'}, {'value': '61.0', 'spread': '45.9', 'groupId': 'OG001'}, {'value': '0', 'spread': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'ORM-12741 plasma trough concentrations at week 12.', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'M-ITT population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low Dose of ORM-12741', 'description': 'ORM-12741: 60mg twice a day'}, {'id': 'FG001', 'title': 'High Dose of ORM-12741', 'description': 'ORM-12741: 200mg twice a day'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo for ORM-12741: Placebo twice a day'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '30'}, {'groupId': 'FG002', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This study was conducted in 4 countries (18 centres): Finland, Poland, Romania and Spain. Of these, 1 centre screened but did not randomise any subjects. Study period was 27 Apr 2011-21 Sep 2012 (first subject first visit to last subject last visit).', 'preAssignmentDetails': 'A total of 132 subjects were screened and 100 were randomized to 3 treatment groups. 30 patients were excluded prior randomization due to inclusion/exclusion criteria, 2 due to personal reasons.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '100', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Low Dose of ORM-12741', 'description': 'ORM-12741: 60mg twice a day'}, {'id': 'BG001', 'title': 'High Dose of ORM-12741', 'description': 'ORM-12741: 200mg twice a day'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo for ORM-12741: Placebo twice a day'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.8', 'spread': '8.2', 'groupId': 'BG000'}, {'value': '71.8', 'spread': '6.8', 'groupId': 'BG001'}, {'value': '72.3', 'spread': '8.5', 'groupId': 'BG002'}, {'value': '72.0', 'spread': '7.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-01', 'studyFirstSubmitDate': '2011-03-24', 'resultsFirstSubmitDate': '2018-03-27', 'studyFirstSubmitQcDate': '2011-03-25', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-01', 'studyFirstPostDateStruct': {'date': '2011-03-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events', 'timeFrame': '3 months', 'description': 'Adverse events from start of ORM-12741 treatment until end of study visit.'}, {'measure': 'Quality of Episodic Memory', 'timeFrame': '3 months', 'description': 'The Cognitive Drug Research (CDR) computerised battery tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning. Quality of Episodic Memory measures the capability of maintaining information in episodic memory and is assessed as the sum of sensitivity indices from 4 memory tasks on the CDR computerised battery tests. Values are calculated by a computer and higher scores mean better outcome.'}, {'measure': 'Quality of Working Memory', 'timeFrame': '3 months', 'description': 'The Cognitive Drug Research (CDR) computerised battery tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning. Quality of Working Memory measures the capability of maintaining information in working memory and is assessed as the sum of sensitivity indices from 2 memory tasks on the CDR computerised battery tests. Values are calculated by a computer and higher scores mean better outcome.'}, {'measure': 'Quality of Memory', 'timeFrame': '3 months', 'description': 'The Cognitive Drug Research (CDR) computerised battery tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning. Quality of Memory is a combination of outcome measures Quality of Working Memory \\& Quality of Episodic Memory. Values are calculated by a computer and higher scores mean better outcome.'}, {'measure': 'Speed of Memory', 'timeFrame': '3 months', 'description': 'The Cognitive Drug Research (CDR) computerised battery tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning. Speed of Memory is assessed as the sum of speed measures from 2 memory tasks and 2 recognition tasks on the CDR computerised battery tests. Values are calculated by a computer and higher scores mean better outcome.'}, {'measure': 'Power of Attention', 'timeFrame': '3 months', 'description': 'The Cognitive Drug Research (CDR) computerised battery tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning. Power of attention measures speed and attention and is assessed from 3 attentional tasks on the CDR computerised battery tests. Values are calculated by a computer and higher scores mean better outcome.'}, {'measure': 'Continuity of Attention', 'timeFrame': '3 months', 'description': 'The Cognitive Drug Research (CDR) computerised battery tests is designed to evaluate the effects of novel compounds on the quality of cognitive functioning. Continuity of attention measures speed and accuracy and is calculated from 3 attentional tasks on the CDR computerised battery tests. Values are calculated by a computer and higher scores mean better outcome.'}], 'secondaryOutcomes': [{'measure': 'NPI Total Score', 'timeFrame': '3 months', 'description': 'The total score of Neuropsychiatric Inventory (NPI) was assessed by a caregiver interview. 10 behavioral areas were included: Delusions, Hallucinations, Agitation/Aggression, Depression/Dysphoria, Anxiety, Elation/Euphoria, Apathy/Indifference, Disinhibition, Irritability/Lability, and Aberrant Motor Behaviour. Higher scores mean worse outcome. Minimum value 0, maximum value 120.'}, {'measure': 'Caregiver Distress Score', 'timeFrame': '3 months', 'description': 'Caregiver distress score generated by adding together the scores of individual NPI distress questions of Neuropsychiatric Inventory NPI. Higher scores mean worse outcome. Minimum value 0, maximum value 120.'}, {'measure': 'Pharmacokinetics of ORM-12741', 'timeFrame': '3 months', 'description': 'ORM-12741 plasma trough concentrations at week 12.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.aan.com/PressRoom/Home/GetDigitalAsset/10708', 'label': 'AAN 65th ANNUAL MEETING ABSTRACT'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine whether ORM-12741 is safe and effective in the treatment of Alzheimer's disease.", 'detailedDescription': "The purpose of this study is to determine whether ORM-12741 is safe and effective in the treatment of cognitive and behavioral symptoms in patients with Alzheimer's disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Informed consent obtained from the patient and legally acceptable representative, if required\n* Informed consent obtained from the caregiver\n* Males and and females between 55-90 years\n* Diagnosis of probable Alzheimer's disease, history of progressive cognitive deterioration\n* Brain imaging consistent with Alzheimer's disease\n* Mini-mental state examination score 12-21\n* Treated with donepezil, rivastigmine or galantamine\n* At least mild level of behavioral symptoms\n\nExclusion Criteria:\n\n* Other types of dementias\n* Modified Hachinski Ischemia Score \\> 4\n* Use of memantine, antipsychotics, anticholinergic medication and benzodiazepines (at a max of 3 nights/week) within 2 months\n* Changes in antidepressant dosing within 2 months\n* Use of other psychotropic agents\n* Myocardial infarction within the past 2 years\n* Malignancy within the past 5 years\n* Suicidal ideation, risk of suicide\n* History of alcoholism or drug abuse within 5 years\n* Clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, neurological or psychiatric disorder or any other major concurrent illness\n* Specific findings in brain imaging\n* Abnormal findings in heart rate, blood pressure, ECG, laboratory tests, physical examination; orthostatic hypotension\n* Blood donation or participation in a drug study within 60 days\n* Previous AD immunotherapy treatment\n* Patient cannot complete the computerised cognitive training\n* Patients who reside in a skilled nursing facility\n* Patients who are not able to swallow capsules"}, 'identificationModule': {'nctId': 'NCT01324518', 'acronym': 'ALPO', 'briefTitle': "Safety and Efficacy of ORM-12741 in Patients With Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Orion Corporation, Orion Pharma'}, 'officialTitle': "Safety and Efficacy of ORM-12741 on Cognitive and Behavioral Symptoms in Patients With Alzheimer's Disease", 'orgStudyIdInfo': {'id': '3098006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low dose of ORM-12741', 'interventionNames': ['Drug: ORM-12741']}, {'type': 'EXPERIMENTAL', 'label': 'High dose of ORM-12741', 'interventionNames': ['Drug: ORM-12741']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo for ORM-12741']}], 'interventions': [{'name': 'ORM-12741', 'type': 'DRUG', 'description': '60mg twice a day', 'armGroupLabels': ['Low dose of ORM-12741']}, {'name': 'ORM-12741', 'type': 'DRUG', 'description': '200mg twice a day', 'armGroupLabels': ['High dose of ORM-12741']}, {'name': 'Placebo for ORM-12741', 'type': 'DRUG', 'description': 'Placebo twice a day', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20520', 'city': 'Turku', 'country': 'Finland', 'facility': 'Clinical Research Services Turku (CRST)', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'overallOfficials': [{'name': 'Juha Rinne, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Research services Turku (CRST)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orion Corporation, Orion Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}