Brodaty Henry, Woodward Michael, Boundy Karyn, Barnes Nicola, Allen Gabrielle
Academic Department for Old Age Psychiatry, School of Psychiatry, University of New South Wales and Prince of Wales Hospital, Randwick, NSW, Australia.
CNS Drugs. 2006;20(11):935-43. doi: 10.2165/00023210-200620110-00006.
To collect descriptive data on the treatment of Alzheimer's disease with galantamine under naturalistic conditions.
This was a prospective, open-label, observational study.
Subjects (n = 345) with mild to moderately severe dementia of the Alzheimer's type were recruited from 48 hospitals in Australia.
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 Instrumental 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.
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.
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.
收集加兰他敏在自然条件下治疗阿尔茨海默病的描述性数据。
这是一项前瞻性、开放标签的观察性研究。
从澳大利亚48家医院招募了345名阿尔茨海默型轻度至中度重度痴呆患者。
在临床实践环境中招募受试者并给予加兰他敏治疗6个月。在基线以及开始治疗后3个月和6个月时，使用简易精神状态检查表（MMSE）、基于临床医生访谈的变化印象加照顾者意见（CIBIC-plus）和阿尔茨海默病评估量表认知子量表（ADAS-cog）对受试者进行评估[仅当基线MMSE评分至少为25分时才使用后者]。还使用一份简化的日常生活工具性活动（IADL）问卷对受试者进行评估，该问卷包括关于使用电话、离家外出超过1公里的出行能力、服药和理财的问题，以及一个11项行为评估量表，该量表测量攻击性、睡眠障碍、脱抑制、人格改变、易怒、抑郁、激动、冷漠、惰性、幻觉和异常运动行为。
在纳入研究的345名受试者（意向性治疗[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。在6个月时，与基线相比，大多数PP受试者（70%）的MMSE评分有所增加，平均得分从基线的20.8±4.2分增加了2.0±3.1分。在ITT人群中，44%的受试者（151/345）在6个月后MMSE评分有所增加。如果数据不可用，则将患者分类为无反应者。在使用ADAS-cog进行评估的21名PP患者中，18名（86%）的ADAS-cog评分下降，反映出认知功能有所改善。在ITT人群中，6个月后33%（19/57）的ADAS-cog评分下降。根据CIBIC-plus评分，大多数PP受试者（86%）被认为是反应者，65%的受试者在6个月的治疗后有一定改善。在ITT人群中，54%（187/345）在6个月后CIBIC-plus评分没有恶化。在6个月期间，大多数PP受试者的IADL或行为评估没有恶化。
在临床实践环境中，大多数完成研究的接受加兰他敏治疗的受试者在6个月期间维持了他们在认知、功能、行为或整体评估方面的评分。
