Galantamine treatment in outpatients with mild Alzheimer's disease.
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 AEs irrespective of causal relationship to study medication were nausea (17.3%), dizziness (12%), and vomiting (10.7%).


CONCLUSIONS
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.
Global Medical Affairs, GMAL Established Products, Janssen Global Services LCC, Titusville, NJ, USA.
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U
Richarz
M
M
Gaudig
K
K
Rettig
B
B
Schauble
D000203:Activities of Daily Living; D000368:Aged; D000544:Alzheimer Disease / Q000188:drug therapy*; D003071:Cognition / Q000187:drug effects; D005260:Female; D005500:Follow-Up Studies; D005702:Galantamine / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D018697:Nootropic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D010045:Outpatients; D011446:Prospective Studies; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
D018697:Nootropic Agents; D005702:Galantamine
ADAS-cog; Alzheimer's disease; Bayer Activity of Daily Living Scale; Neuropsychiatric Inventory; adverse effects; galantamine