A naturalistic study of galantamine for Alzheimer's disease
A naturalistic study of galantamine for Alzheimer's disease
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DOI：
10.2165/00023210-200620110-00006
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发表时间：
2006-01-01
期刊：
影响因子：
6
通讯作者：
Allen, Gabrielle
中科院分区：
文献类型：
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作者：
Brodaty, Henry;Woodward, Michael;Allen, Gabrielle
目的：研究设计：这是一项前瞻性、开放标签、观察性研究。患者：从澳大利亚的48家医院招募了345名患有轻度至中度严重阿尔茨海默型痴呆的受试者。受试者入组并在临床实践环境中接受加兰他敏治疗6个月。在基线和开始治疗后3个月和6个月，使用简易精神状态检查（MMSE）、基于临床医生访谈的变化印象加护理人员输入（CIBIC-plus）和阿尔茨海默病评估量表-认知子量表（ADAS-cog）[后者仅在基线MMSE评分至少为25时使用]对受试者进行评估。还使用简化的工具性日常生活活动（IADL）问卷对受试者进行了评估，该问卷包括使用电话的问题，离家1公里以上旅行的能力，服用药物和管理金钱，以及11项行为评估量表，该量表测量了攻击性，睡眠障碍，去抑制，性格变化，易怒，抑郁，激动，冷漠，惰性，结果：在参加研究的345名受试者（意向治疗[ITT]人群）中，229名完成了基线、3个月和6个月的访视（符合方案[PP]人群）。PP人群的平均年龄为78.0 +/- 6.8岁。6个月时，大多数PP受试者（70%）的MMSE评分较基线增加，评分较基线20.8 +/- 4.2分平均增加2.0 +/- 3.1分。在ITT人群中，44%的受试者（151/345）在6个月后显示MMSE升高。如果数据不可用，则将患者归类为无应答者。在使用ADAS-cog评估的21例PP患者中，18例（86%）显示ADAS-cog评分降低，反映了认知改善。在ITT人群中，33%（19/57）在6个月后ADAS-cog评分降低。根据CIBIC-plus评分，大多数PP受试者（86%）被认为是应答者，65%在6个月的治疗中显示出一定程度的改善。在ITT人群中，54%（187/345）的受试者在6个月后CIBIC-plus评分没有恶化。在大多数PP受试者中，6个月后IADL或行为评估没有恶化。在临床实践环境中，大多数接受加兰他敏并完成研究的受试者在6个月期间保持了认知、功能、行为或总体评估的评级。
Objective: To collect descriptive data on the treatment of Alzheimer's disease with galantamine under naturalistic conditions.Study design: This was a prospective, open-label, observational study.Patients: Subjects (n = 345) with mild to moderately severe dementia of the Alzheimer's type were recruited from 48 hospitals in Australia.Methods: Subjects were enrolled and received treatment with galantamine for 6 months in a clinical practice setting. Subjects were assessed at baseline and 3 and 6 months after starting treatment using the Mini-Mental State Examination (MMSE), the Clinician's Interview-Based Impression of Change plus Caregiver Input (CIBIC-plus) and the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) [the latter only if the baseline MMSE score was at least 25]. Subjects were also assessed using an abridged Instrumantal Activities of Daily Living (IADL) questionnaire that included questions on using the telephone, ability to travel more than 1km outside the home, taking medications and managing money, and an 11-item behaviour assessment scale that measured aggression, sleep disturbance, disinhibition, personality changes, irritability, depression, agitation, apathy, inertia, hallucinations and aberrant motor behaviour.Results: Of the 345 subjects who were enrolled in the study (intent-to-treat [ITT] population), 229 completed the baseline, 3- and 6-month visits (per-protocol [PP] population). The mean age of the PP population was 78.0 +/- 6.8 years.At 6 months, most PP subjects (70%) showed an increase in MMSE score compared with baseline, with a mean increase in score of 2.0 +/- 3.1 points from a baseline of 20.8 +/- 4.2 points. In the ITT population, 44% of subjects (151/345) showed an increase in MMSE after 6 months. If data were unavailable the patient was classified as a nonresponder. Of the 21 PP patients who were assessed using ADAS-cog, 18 (86%) demonstrated a decrease in the ADAS-cog score, reflecting an improvement in cognition. Of the ITT population, 33% (19/57) had a decreased ADAS-cog score after 6 months.Most PP subjects (86%) were considered responders according to the CIBIC-plus score, with 65% showing some improvement over 6 months of treatment. Of the ITT population, 54% (187/345) showed no deterioration in CIBIC-plus score after 6 months.No deterioration in IADL or behaviour assessments occurred in the majority of PP subjects over 6 months.Conclusions: In a clinical practice setting, the majority of subjects receiving galantamine who completed the study maintained their ratings of cognition, function, behaviour or global assessment over the 6-month period.