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Galantamine treatment in outpatients with mild Alzheimer's disease
Author(s) -
Richarz U.,
Gaudig M.,
Rettig K.,
Schauble B.
Publication year - 2014
Publication title -
acta neurologica scandinavica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.967
H-Index - 95
eISSN - 1600-0404
pISSN - 0001-6314
DOI - 10.1111/ane.12195
Subject(s) - galantamine , tolerability , nausea , medicine , activities of daily living , dementia , physical therapy , disease , adverse effect , donepezil
Objective To assess long‐term effectiveness of galantamine in community‐dwelling persons with mild Alzheimer's disease. Methods Prospective open‐label trial including patients with mild AD ( NINCDS ‐ ADRDA criteria) treated with galantamine for up to 36 months. Outcome parameters included ADAS ‐cog/11, Bayer‐ ADL scale (self‐ and caregivers' ratings), 10‐item NPI and CGI ‐change, safety and tolerability measures. Data are presented based on ITT analyses ( LOCF ). Results Seventy‐five patients (55% women; mean ADAS ‐cog 22.3; mean age 70.2 years) were treated with galantamine for approximately 36 months. About 60% ( n = 45) received a total daily dose of 24 mg galantamine at final visit. After 3, 6, and 12 months of treatment, mean improvements in ADAS ‐cog ranged between 2.2 and 3.0 points (all P < 0.05). After 24‐month treatment, ADAS ‐cog returned to baseline value and at 3‐year follow‐up, patient deteriorated on average by 2.9 points. There was significant improvement on the NPI scale between baseline and 3‐ to 12‐month follow‐up (all P < 0.05) and at 3‐year endpoint, a slight deterioration was noted. Activities of daily living (B‐ ADL ) decreased significantly after 24 months in self‐ratings and after 12 months in caregivers' ratings. Fifty‐four patients reported at least one AE , most of them occurring during the first 2 years of treatment. Among the most frequently (>10%) reported AE s irrespective of causal relationship to study medication were nausea (17.3%), dizziness (12%), and vomiting (10.7%). Conclusion Galantamine was generally safe and well tolerated during the 3‐year observation period. Cognition, behavior, and activities of daily living improved during 12 months treatment. At 3‐year follow‐up, worsening in all outcomes was measured; however, cognition remained improved compared with an untreated population.