A Study of the Safety and Effectiveness of Galantamine Hydrobromide in Patients With Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT00297362|
Recruitment Status : Completed
First Posted : February 28, 2006
Last Update Posted : March 26, 2012
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Drug: Galantamine hydrobromide||Phase 4|
|Study Type :||Observational|
|Actual Enrollment :||344 participants|
|Official Title:||Open Observational Study of Galantamine Hydrobromide Administration for the Treatment of Patients With Mild to Moderate Dementia of the Alzheimer Type|
|Study Start Date :||June 2004|
|Study Completion Date :||October 2005|
U.S. FDA Resources
Drug: Galantamine hydrobromide
247 patients with diagnosed mild to moderate Alzheimer disease.
- Changes from baseline in Mini-Mental State Examination (MMSE) scale scores [ Time Frame: Baseline to 6 months ]The MMSE is a brief 30-point questionnaire test that is used to screen for cognitive impairment. A score greater than or equal to 25 points is effectively normal (intact). Below this, scores can indicate severe (≤9 points), moderate (10-20 points) or mild (21-24 points) cognitive impairment.
- Changes from baseline in Disability Assessment for Dementia (DAD) scale scores [ Time Frame: Baseline to 6 months ]The 40-item DAD scale assesses functional abilities in activities of daily living in patients with dementia and other cognitive impairments. Higher scores indicate less disability while lower scores denote more difficulties.
- Changes from baseline in Neuropsychiatric Inventory (NPI) scale scores [ Time Frame: Baseline to 6 months ]The NPI assesses psychopathology in dementia patients. It evaluates 12 neuropsychiatric disturbances common in dementia: delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, night-time behavior disturbances, and appetite and eating abnormalities. Both the frequency (from rarely to very often) and the severity (from mild to severe) of each behavior are determined.
- Changes from baseline in Clinical Global Impression (CGI) scale scores [ Time Frame: Baseline to 6 months ]The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill patients".
- Changes from baseline in Cornell Scale [ Time Frame: Baseline to 6 months ]The Cornell Scale assesses signs and symptoms of major depression in patients with dementia. Each item is rated for severity on a scale of 0-2 (0=absent, 1=mild or intermittent, 2=severe). The item scores are added. Scores above 10 indicate a probable major depression. Scores above 18 indicate a definite major depression. Scores below 6 as a rule are associated with absence of significant depressive symptoms.
- Number of patients with Adverse Events as Measure of Safety and Tolerability [ Time Frame: 6 months ]
- Number of patients whose vital signs fell outside the normal ranges [ Time Frame: 6 months ]
- Number of patients whose laboratory test results fell outside the normal ranges [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00297362
|Study Director:||Janssen-Cilag Pharmaceutica S.A.C.I. Clinical Trial||Janssen-Cilag Pharmaceutica S.A.C.I.|