Kertesz A, Morlog D, Light M, Blair M, Davidson W, Jesso S, Brashear R
Cognitive Neurology and Alzheimer Research Centre, St. Joseph's Hospital, London, Ont., USA.
Dement Geriatr Cogn Disord. 2008;25(2):178-85. doi: 10.1159/000113034. Epub 2008 Jan 14.
BACKGROUND/AIMS: The treatment of frontotemporal dementia (FTD) has been mainly symptomatic. Small randomized or open-label case control studies of neurotransmitters have been inconclusive. We tried galantamine in the 2 most common varieties of FTD.
Thirty-six behavioral variety FTD and primary progressive aphasia (PPA) patients were treated in an open-label period of 18 weeks and a randomized, placebo-controlled phase for 8 weeks with galantamine. The primary efficacy measures were the Frontal Behavioral Inventory, the Aphasia Quotient of the Western Aphasia Battery, the Clinical Global Impression of Severity and the Clinical Global Impression of Improvement.
No significant differences in behavior or language were found for the total group. A treatment effect (p = 0.009), in a subgroup of subjects with PPA in the global severity score, in favor of galantamine was detected in the placebo-controlled withdrawal phase but was not considered significant after correction for multiple comparisons. The language scores for the treated PPA group also remained stable compared to the placebo group, which showed deterioration.
Galantamine is not effective in the behavioral variety of FTD, but a trend of efficacy is shown in the aphasic subgroup, which may be clinically significant. Galantamine appeared safe in FTD/PPA.
背景/目的:额颞叶痴呆(FTD)的治疗主要是对症治疗。关于神经递质的小型随机或开放标签病例对照研究尚无定论。我们在两种最常见的FTD类型中试用了加兰他敏。
36例行为变异型FTD和原发性进行性失语(PPA)患者接受了为期18周的开放标签期治疗,并随机接受加兰他敏治疗8周,设安慰剂对照。主要疗效指标包括额叶行为量表、西方失语成套测验失语商数、临床总体严重程度印象和临床总体改善印象。
总体组在行为或语言方面未发现显著差异。在安慰剂对照撤药期,检测到在全球严重程度评分中,PPA亚组有治疗效果(p = 0.009),支持加兰他敏,但在进行多重比较校正后不认为具有显著性。与显示病情恶化的安慰剂组相比,接受治疗的PPA组的语言评分也保持稳定。
加兰他敏对行为变异型FTD无效,但在失语亚组中显示出疗效趋势,这可能具有临床意义。加兰他敏在FTD/PPA中似乎是安全的。