Small Gary, Erkinjuntti Timo, Kurz Alexander, Lilienfeld Sean
Department of Psychiatry and Biobehavioral Sciences and Neuropsychiatric Institute, David Geffen School of Medicine at University of California-Los Angeles, Los Angeles, California 90024, USA.
CNS Drugs. 2003;17(12):905-14. doi: 10.2165/00023210-200317120-00004.
Alzheimer's disease and vascular dementia are the two most common types of dementia, with significant overlap of clinical symptoms and pathology. Previous results from a 6-month, double-blind, placebo-controlled, international, multicentre study of the cholinomimetic galantamine in patients with probable vascular dementia or mixed dementia (Alzheimer's disease with cerebrovascular disease) showed significant cognitive, behavioural and functional benefits in these patients. Furthermore, results of a 6-month, open-label extension of this study confirmed that patients with vascular dementia or Alzheimer's disease with cerebrovascular disease may benefit from galantamine therapy for at least 1 year. The objective of the current analysis was to determine if the long-term cognitive benefits of galantamine seen in the above-mentioned study are influenced by dementia type (probable vascular dementia vs Alzheimer's disease with cerebrovascular disease).
A post hoc sub-analysis of a 6-month, multicentre, randomised, double-blind, placebo-controlled study and a subsequent 6-month, open-label extension.
Patients diagnosed with probable vascular dementia or Alzheimer's disease with cerebrovascular disease were treated with galantamine (Reminyl) 24 mg/day for 12 months (6 months double-blind and 6 months open-label) or placebo for 6 months (double-blind) followed by galantamine 24 mg/day for 6 months (open-label). Changes in scores on the 11-item Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog/11) were assessed at months 6, 7.5 and 12. Mean changes from baseline were analysed.
Patients with probable vascular dementia treated with galantamine for 6 or 12 months showed significant improvements in ADAS-cog/11 scores versus baseline, which were maintained at the end of the 12-month study. Patients who had Alzheimer's disease with cerebrovascular disease continuously treated with galantamine maintained the cognitive abilities seen at baseline for at least 12 months. Additionally, patients who had Alzheimer's disease with cerebrovascular disease who were switched from placebo to open-label galantamine therapy for 6 months demonstrated cognitive benefits, but these benefits were significantly less than those observed in patients treated with galantamine continuously for the 12-month period. Galantamine was well tolerated throughout the entire 12-month study.
These findings suggest that the drug is efficacious for such common forms of dementia as vascular dementia and Alzheimer's disease with cerebrovascular disease. Moreover, some patients benefit from galantamine therapy that is initiated early, soon after diagnosis, and continued for at least 1 year.
阿尔茨海默病和血管性痴呆是两种最常见的痴呆类型，临床症状和病理表现有显著重叠。先前一项为期6个月、双盲、安慰剂对照、国际性、多中心的拟胆碱药加兰他敏治疗可能的血管性痴呆或混合性痴呆（伴有脑血管病的阿尔茨海默病）患者的研究结果显示，这些患者在认知、行为和功能方面有显著改善。此外，该研究为期6个月的开放标签延长期结果证实，血管性痴呆或伴有脑血管病的阿尔茨海默病患者可能从加兰他敏治疗中获益至少1年。当前分析的目的是确定在上述研究中观察到的加兰他敏的长期认知益处是否受痴呆类型（可能的血管性痴呆与伴有脑血管病的阿尔茨海默病）影响。
对一项为期6个月的多中心、随机、双盲、安慰剂对照研究及随后为期6个月的开放标签延长期研究进行事后亚组分析。
诊断为可能的血管性痴呆或伴有脑血管病的阿尔茨海默病的患者接受加兰他敏（雷米诺林）24毫克/天治疗12个月（6个月双盲和6个月开放标签），或接受安慰剂治疗6个月（双盲），随后接受加兰他敏24毫克/天治疗6个月（开放标签）。在第6、7.5和12个月评估11项阿尔茨海默病评估量表认知子量表（ADAS-cog/11）的得分变化。分析与基线相比的平均变化。
接受加兰他敏治疗6个月或12个月的可能的血管性痴呆患者，其ADAS-cog/11得分与基线相比有显著改善，在为期12个月的研究结束时仍保持改善。持续接受加兰他敏治疗的伴有脑血管病的阿尔茨海默病患者至少12个月维持了基线时的认知能力。此外，从安慰剂转换为开放标签加兰他敏治疗6个月的伴有脑血管病的阿尔茨海默病患者显示出认知益处，但这些益处明显小于持续接受加兰他敏治疗12个月的患者所观察到的益处。在整个为期12个月的研究中，加兰他敏耐受性良好。
这些发现表明，该药物对血管性痴呆和伴有脑血管病的阿尔茨海默病等常见形式的痴呆有效。此外，一些患者在诊断后尽早开始并持续至少1年的加兰他敏治疗中获益。
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