Objective: To present the characteristics of individuals enrolled in clinical studies to evaluate the effects of galantamine in the treatment of patients with mild cognitive impairment (MCI).
Design: The efficacy and safety of galantamine in the treatment of MCI is currently being evaluated in 2 international, multicenter, double-blind, randomized, placebo-controlled trials with a duration of 24 months. Following a 4-week washout period, more than 2,000 patients were randomized 1:1 to either placebo or galantamine 16 to 24 mg/day using a flexible dose-escalation schedule. Subjects were required to meet the following criteria to be included in the study: 1) outpatients 50 years of age or older, 2) a gradual onset and slow progression of cognitive impairment consistent with MCI (CDR score = 0.5), 3) insufficient impairment of activities of daily living for diagnosis of dementia, and 4) NYU Paragraph Recall Test with delayed recall score less than or equal to 10.
Materials and methods: Clinical efficacy will be measured by assessments in memory and attention, global severity of dementia severity, and function. Safety and tolerability will be also assessed.
Results: The blinded baseline characteristics are described in the Table.
|
| N (%) |
| Overall patient population | 2,057 (100) |
| Ethnic category White (Non-Hispanic) Hispanic Black or African American (Non-Hispanic) Asian or Pacific Islander American Indian or Alaskan Native Other Total |
1,954 (95) 62 (3) 31 (1.5) 4 (0.2) 0 6 (2.9) 2,057 (100) |
| Age category Adult (18–64 years) Elderly (65–74 years) Elderly (75 years and older) Total |
548 (26.6) 778 (37.8) 731 (35.5) 2,057 (100) |
| Gender Male Female Total |
918 (44.6) 1,139 (55.4) 2057 (100) |
Conclusions: The characteristics of patients with MCI who enrolled in these 2 studies are consistent with previously published descriptions of MCI and may provide assistance when determining who is at greater risk for developing this disorder.
Back to PB Tuesday Poster Sessions
Back to The Eleventh International Congress