Ignite Creation Date:
2025-12-24 @ 7:44 PM
Ignite Modification Date:
2025-12-29 @ 9:01 PM
Study NCT ID:
NCT00889603
Status:
COMPLETED
Last Update Posted:
2011-03-31
First Post:
2009-04-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Non-Interventional Study With Aricept® Evess
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D015140', 'term': 'Dementia, Vascular'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D002537', 'term': 'Intracranial Arteriosclerosis'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D056784', 'term': 'Leukoencephalopathies'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'FAQ Change from baseline not analyzed, a note to file was issued stating it was removed from protocol but erroneously remained in statistical analysis section. Patient Domain of Benefit, Week 24 LOCF not analyzed; endpoint only collected at Week 24.'}}, 'adverseEventsModule': {'description': 'The same event may appear as both an adverse event (AE) and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Donepezil', 'description': '5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing', 'otherNumAtRisk': 370, 'otherNumAffected': 52, 'seriousNumAtRisk': 370, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Irritability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Aphasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cerebral disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Partial seizures', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Psychomotor hyperactivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Sedation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Delusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypomania', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Impulse-control disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 13}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Restlessness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Sleep disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'seriousEvents': [{'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Ventricular fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Grand mal convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abnormal behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Withdrawal syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 370, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Mini Mental State Examination (MMSE) Total at Week 24 Last Observation Carried Forward (LOCF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '351', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Donepezil', 'description': '5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing'}], 'classes': [{'categories': [{'measurements': [{'value': '1.92', 'spread': '0.14', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.92', 'ciLowerLimit': '1.65', 'ciUpperLimit': '2.20', 'estimateComment': 'Change from baseline in MMSE at LOCF analyzed using single-sample t-test; a 95% confidence interval (CI) was calculated for mean change at LOCF.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, higher score indicated better cognitive state. Change: mean score at Week 24 LOCF minus mean score at baseline.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): all participants who received at least 1 dose of Donepezil and had at least 1 postbaseline efficacy evaluation. LOCF was used. N=number of participants with evaluable data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in MMSE Total', 'denoms': [{'units': 'Participants', 'counts': [{'value': '348', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Donepezil', 'description': '5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing'}], 'classes': [{'title': 'Week 8 (N=348)', 'categories': [{'measurements': [{'value': '0.92', 'spread': '0.09', 'groupId': 'OG000'}]}]}, {'title': 'Week 16 (N=340)', 'categories': [{'measurements': [{'value': '1.56', 'spread': '0.12', 'groupId': 'OG000'}]}]}, {'title': 'Week 24 (N=327)', 'categories': [{'measurements': [{'value': '1.97', 'spread': '0.14', 'groupId': 'OG000'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.92', 'ciLowerLimit': '0.75', 'ciUpperLimit': '1.08', 'estimateComment': 'LS Mean and 95% CI for change from baseline in MMSE Total to Week 8 from repeated-measures mixed model including terms for baseline MMSE and Week.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.56', 'ciLowerLimit': '1.32', 'ciUpperLimit': '1.80', 'estimateComment': 'LS Mean and 95% CI for change from baseline in MMSE Total to Week 16 from a repeated-measures mixed model including terms for baseline MMSE and Week.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.97', 'ciLowerLimit': '1.69', 'ciUpperLimit': '2.25', 'estimateComment': 'LS Mean and 95% CI for change from baseline in MMSE Total to Week 24 from a repeated-measures mixed model including terms for baseline MMSE and Week.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Week 8, 16, and 24', 'description': 'MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, higher score indicated better cognitive state. Change: least squares (LS) mean score at observation minus LS mean score at baseline. Changes from baseline at each week were controlled for baseline MMSE.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. N=number of participants with evaluable data.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Functional Activity Questionnaire (FAQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Donepezil', 'description': '5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 24', 'description': 'Participants completed the FAQ for physical function. Overall scores could have ranged from 0 (independent) to 30 (dependent) where lower scores represented an improvement in physical function. Change from baseline was to be calculated as baseline scores minus week 24 scores.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. Data not analyzed'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '351', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Donepezil', 'description': '5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing'}], 'classes': [{'title': 'Very much improved', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Much improved', 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}]}]}, {'title': 'Minimally improved', 'categories': [{'measurements': [{'value': '194', 'groupId': 'OG000'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}]}]}, {'title': 'Minimally worse', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Much worse', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 8', 'description': 'CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. N=number of participants with evaluable data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '341', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Donepezil', 'description': '5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing'}], 'classes': [{'title': 'Very much improved', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Much improved', 'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}]}]}, {'title': 'Minimally improved', 'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}]}]}, {'title': 'Minimally worse', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Much worse', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 16', 'description': 'CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. N=number of participants with evaluable data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Donepezil', 'description': '5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing'}], 'classes': [{'title': 'Very much improved', 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}]}]}, {'title': 'Much improved', 'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}]}]}, {'title': 'Minimally improved', 'categories': [{'measurements': [{'value': '87', 'groupId': 'OG000'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG000'}]}]}, {'title': 'Minimally worse', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Much worse', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Very much worse', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS. N=number of participants with evaluable data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24 LOCF', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Donepezil', 'description': '5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing'}], 'classes': [{'title': 'Very much improved', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}, {'title': 'Much improved', 'categories': [{'measurements': [{'value': '133', 'groupId': 'OG000'}]}]}, {'title': 'Minimally improved', 'categories': [{'measurements': [{'value': '95', 'groupId': 'OG000'}]}]}, {'title': 'No change', 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}, {'title': 'Minimally worse', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Much worse', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Very much worse', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS; LOCF. N=number of participants with evaluable data.'}, {'type': 'SECONDARY', 'title': 'Number of Participants in Each Patient Domain of Benefit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '335', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Donepezil', 'description': '5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing'}], 'classes': [{'title': 'Cognition', 'categories': [{'measurements': [{'value': '202', 'groupId': 'OG000'}]}]}, {'title': 'Functionality', 'categories': [{'measurements': [{'value': '215', 'groupId': 'OG000'}]}]}, {'title': 'Behavior', 'categories': [{'measurements': [{'value': '193', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': "Participants asked to indicate if the cognition, functionality, and/or behavior domain were most benefited/improved after treatment (dichotomous yes/no endpoints where checking the CRF box next to each domain indicated 'yes' and leaving a box blank indicated 'no').", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population: all participants who received at least 1 dose of study drug. N=number of participants with evaluable data. Week 24 LOCF not reported as data only collected at Week 24.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Treatment Tolerability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '331', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Donepezil', 'description': '5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing'}], 'classes': [{'title': 'Very Good', 'categories': [{'measurements': [{'value': '186', 'groupId': 'OG000'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000'}]}]}, {'title': 'Moderate', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}]}]}, {'title': 'Poor', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 24', 'description': 'Overall Evaluation of Tolerability at Week 24; 1=Very good, 2=Good, 3=Moderate, 4=Poor', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population; N=number of particpants with evaluable data.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants Receiving Other Medications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Donepezil', 'description': '5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '205', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'categories': [{'measurements': [{'value': '270', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and Week 24', 'description': 'Information collected and recorded by investigator in accordance with existing medical records. World Health Organization- Drug (WHO-Drug) coding dictionary applied.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Donepezil', 'description': '5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '370'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '333'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'No longer willing to participant in stud', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '370', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Donepezil', 'description': '5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Less than 65 years', 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000'}]}]}, {'title': '65 to 74 years', 'categories': [{'measurements': [{'value': '130', 'groupId': 'BG000'}]}]}, {'title': '75 to 84 years', 'categories': [{'measurements': [{'value': '142', 'groupId': 'BG000'}]}]}, {'title': 'Greater than or equal to 85 years', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '200', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '170', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 370}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-03', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-03-04', 'studyFirstSubmitDate': '2009-04-27', 'resultsFirstSubmitDate': '2011-01-26', 'studyFirstSubmitQcDate': '2009-04-28', 'lastUpdatePostDateStruct': {'date': '2011-03-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-03-04', 'studyFirstPostDateStruct': {'date': '2009-04-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-03-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Treatment Tolerability', 'timeFrame': 'Week 24', 'description': 'Overall Evaluation of Tolerability at Week 24; 1=Very good, 2=Good, 3=Moderate, 4=Poor'}, {'measure': 'Number of Participants Receiving Other Medications', 'timeFrame': 'Baseline and Week 24', 'description': 'Information collected and recorded by investigator in accordance with existing medical records. World Health Organization- Drug (WHO-Drug) coding dictionary applied.'}], 'primaryOutcomes': [{'measure': 'Change From Baseline in Mini Mental State Examination (MMSE) Total at Week 24 Last Observation Carried Forward (LOCF)', 'timeFrame': 'Baseline and Week 24', 'description': 'MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, higher score indicated better cognitive state. Change: mean score at Week 24 LOCF minus mean score at baseline.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in MMSE Total', 'timeFrame': 'Baseline, Week 8, 16, and 24', 'description': 'MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, higher score indicated better cognitive state. Change: least squares (LS) mean score at observation minus LS mean score at baseline. Changes from baseline at each week were controlled for baseline MMSE.'}, {'measure': 'Change From Baseline in Functional Activity Questionnaire (FAQ)', 'timeFrame': 'Baseline and Week 24', 'description': 'Participants completed the FAQ for physical function. Overall scores could have ranged from 0 (independent) to 30 (dependent) where lower scores represented an improvement in physical function. Change from baseline was to be calculated as baseline scores minus week 24 scores.'}, {'measure': 'Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 8', 'timeFrame': 'Week 8', 'description': 'CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.'}, {'measure': 'Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 16', 'timeFrame': 'Week 16', 'description': 'CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.'}, {'measure': 'Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24', 'timeFrame': 'Week 24', 'description': 'CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.'}, {'measure': 'Number of Participants With Categorical Scores on Clinical Global Impression - Improvement (CGI-I) at Week 24 LOCF', 'timeFrame': 'Week 24', 'description': 'CGI-I: 7-point Investigator-rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement was defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.'}, {'measure': 'Number of Participants in Each Patient Domain of Benefit', 'timeFrame': 'Week 24', 'description': "Participants asked to indicate if the cognition, functionality, and/or behavior domain were most benefited/improved after treatment (dichotomous yes/no endpoints where checking the CRF box next to each domain indicated 'yes' and leaving a box blank indicated 'no')."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Aricept® Evess', 'non-interventional study', "Alzheimer's Disease", 'Vascular Dementia', 'efficacy', 'tolerability', 'safety.'], 'conditions': ["Alzheimer's Disease", 'Vascular Dementia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2501065&StudyName=Non-Interventional%20Study%20With%20Aricept%AE%20Evess%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The Aricept® Evess study is a prospective, non-comparative, non-interventional study on use of Aricept® Evess in the treatment of out-patients with AD and Vascular Dementia. The 24 week length of the study aims to collect data from a large number of patients (n= 400) on the safety and efficacy at the usual dosage of the product providing an overview of Aricept® Evess profile.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The patients will be selected from those addressing psychiatrists on an outpatient bases, male / female, older than 50 years, being diagnosed with Alzheimer's Disease and Vascular Dementia, with MMSE score between 12 - 24.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Outpatients (male / female), older than 50 years.\n* Patients with clinical symptoms of mild and moderate AD and Vascular Dementia.\n* MMSE score between 12 - 24.\n\nExclusion Criteria:\n\n* Patients with a known hypersensitivity to donepezil clorhydrat, piperidine derivatives or any of the excipients of Aricept® Evess.\n* Patients with severe impaired hepatic function.\n* Patients with pre-existing gastrointestinal ulcer disease.\n* Patients with the history of bronchial asthma or chronic obstructive lung disease.\n* Patients with the history of serious atrioventricular conduction disturbances.'}, 'identificationModule': {'nctId': 'NCT00889603', 'briefTitle': 'Non-Interventional Study With Aricept® Evess', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': "Non-Interventional Study With Aricept® Evess In Patients Diagnosed With Mild And Moderate Alzheimer's Disease Or Vascular Dementia", 'orgStudyIdInfo': {'id': 'A2501065'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'interventionNames': ['Drug: Aricept® Evess']}], 'interventions': [{'name': 'Aricept® Evess', 'type': 'DRUG', 'description': '5 mg film-coated orodispersible tablets, 10 mg film-coated orodispersible tablets.\n\nTreatment may be started with 5 mg donepezil/ day (once-a-day dosing) and after four weeks can be titrated to 10 mg/day (once-a-day dosing).', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '600114', 'city': 'Bacau', 'state': 'Jud. Bacau', 'country': 'Romania', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 46.56718, 'lon': 26.91384}}, {'zip': '400001', 'city': 'Cluj-Napoca', 'state': 'Jud. Cluj', 'country': 'Romania', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'city': 'Cluj-Napoca', 'state': 'Jud. Cluj', 'country': 'Romania', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 46.76667, 'lon': 23.6}}, {'city': 'Constanța', 'state': 'Jud. Constanta', 'country': 'Romania', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 44.18073, 'lon': 28.63432}}, {'city': 'Craiova', 'state': 'Jud. Dolj', 'country': 'Romania', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 44.31667, 'lon': 23.8}}, {'zip': '700282', 'city': 'Iași', 'state': 'Jud. Iasi', 'country': 'Romania', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}, {'city': 'Ploieşti', 'state': 'Jud. Prahova', 'country': 'Romania', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 44.95, 'lon': 26.01667}}, {'city': 'Timișoara', 'state': 'Jud. Timis', 'country': 'Romania', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}, {'zip': '041902', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '061301', 'city': 'Bucharest', 'country': 'Romania', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'city': 'Bucharest', 'country': 'Romania', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 44.43225, 'lon': 26.10626}}, {'zip': '700282', 'city': 'Iași', 'country': 'Romania', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}