Holland Peter J, Tappen Ruth M, Newman David O, Freeman-Costin Katherine C, Fisher Lori J
Schmidt College of Medicine, Florida Atlantic University, Boca Raton, FL.
Christine E. Lynn College of Nursing, Florida Atlantic University, Boca Raton, FL, USA.
Can Geriatr J. 2021 Dec 1;24(4):292-296. doi: 10.5770/cgj.24.540. eCollection 2021 Dec.
To determine the feasibility of conducting an RCT on the potential effectiveness of memantine hydrochloride in prolonging safe driving in mild AD.
A placebo-controlled, double blind randomized trial was conducted. Forty-three individuals ≥60 with mild AD met screening criteria and were randomized. Driving ability was measured by a standardized on-road driving test. Outcomes were driving capacity at 6 and 12 months and completion of the 12-month intervention.
Of 43 participants randomized, 59% of the memantine group and 52% of the placebo group completed the on-road test at 12 months ( = .66). All 13 memantine group participants maintained their driving status at 12 months, whereas only 8 of the 11 placebo group participants did ( = .040, OR = 4.45).
Results provide the framework for designing a rigorous multisite clinical trial of memantine effect on maintaining driving capacity in mild AD.
确定开展一项关于盐酸美金刚在延长轻度阿尔茨海默病（AD）患者安全驾驶时间方面潜在有效性的随机对照试验（RCT）的可行性。
进行了一项安慰剂对照、双盲随机试验。43名年龄≥60岁的轻度AD患者符合筛查标准并被随机分组。驾驶能力通过标准化的道路驾驶测试来衡量。结局指标为6个月和12个月时的驾驶能力以及12个月干预的完成情况。
在随机分组的43名参与者中，美金刚组59%和安慰剂组52%的患者在12个月时完成了道路测试（P = 0.66）。美金刚组的所有13名参与者在12个月时维持了其驾驶状态，而安慰剂组的11名参与者中只有8名维持了驾驶状态（P = 0.040，比值比 = 4.45）。
研究结果为设计一项关于美金刚对维持轻度AD患者驾驶能力影响的严谨多中心临床试验提供了框架。
