Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT00630851
Status:
COMPLETED
Last Update Posted:
2015-03-05
First Post:
2008-02-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of the Efficacy and Safety of Aricept in Patients With Severe Alzheimer's Disease Who Are Living in Skilled Nursing Homes
Sponsor:
Organization:
Raw JSON
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'2008-03-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change from baseline in modified Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Severe Alzheimer's Disease (ADCS-ADL-severe) total score", 'timeFrame': 'Month 6'}, {'measure': 'Change from baseline in Severe Impairment Battery (SIB) total score', 'timeFrame': 'Month 6'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in SIB total score', 'timeFrame': 'Month 3'}, {'measure': 'Change from baseline in Neuropsychiatric Inventory (NPI) total score', 'timeFrame': 'Months 3 and 6'}, {'measure': 'Change from inclusion in Mini Mental State Examination (MMSE) total score', 'timeFrame': 'Month 6'}, {'measure': 'Change from baseline in Clinical Global Impression of Improvement (CGI-I) score', 'timeFrame': 'Months 3 and 6'}, {'measure': 'Adverse events and laboratory value changes', 'timeFrame': 'Months 3 and 6'}, {'measure': 'Change from baseline in modified ADCS-ADL-severe total score', 'timeFrame': 'Month 3'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Alzheimer Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2501017&StudyName=A%20study%20of%20the%20efficacy%20and%20safety%20of%20Aricept%20in%20patients%20with%20severe%20Alzheimer%27s%20disease%20who%20are%20living%20in%20skilled%20nursing%20homes', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': "The purpose of the study is to evaluate the efficacy and safety of Aricept in nursing home patients with severe Alzheimer's disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Probable or possible Alzheimer's disease\n* Living in skilled nursing home\n\nExclusion 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