Alvarez X A, Pichel V, Pérez P, Laredo M, Corzo D, Zas R, Fernández-Novoa L, Sempere J M, Díaz J, Cacabelos R
EuroEspes Biomedical Research Center, A Coruña, Spain.
Methods Find Exp Clin Pharmacol. 2000 Sep;22(7):585-94.
The aim of this study was to evaluate the effects of two doses of anapsos in comparison with placebo on cognitive performance, brain bioelectrical activity pattern and cerebral hemodynamic parameters in patients with mild to moderate senile dementia of vascular type and Alzheimer type. Forty-five patients (age 73.8 +/- 7.6 years; range 56-89 years) with mild to moderate senile dementia (Global Deterioration Scale: stages 3-5) of the vascular (VD; n = 22) or the Alzheimer type (AD; n = 23) were included in a double-blind randomized placebo-controlled clinical trial. After a 2-week period of drug washout, patients were treated with placebo (n = 15; age 72.7 +/- 7.5 years), 360 mg/day of anapsos (n = 15; age 75.5 +/- 7.2 years), or 720 mg/day of anapsos (n = 15; age 73 +/- 7.7 years) for 4 weeks (28 days). At baseline and after the 4-week period of double-blind treatment, cognitive performance, brain bioelectrical activity power and blood flow hemodynamics in the middle cerebral arteries were evaluated with ADAScog, brain mapping and transcranial Doppler ultrasonography, respectively. Patients receiving 360 mg/day of anapsos showed a significant improvement in cognitive performance after treatment (ADAScog scores: p < 0.05) that was not observed in patients treated with placebo or 720 mg/day of anapsos. As compared to placebo, anapsos (360 mg/day) induced a significant improvement in ADAScog scores in mild senile dementia patients (p < 0.01) and in the subset of patients with AD (p < 0.05). Anapsos (360 mg/day) also increased cerebral blood flow velocities in left and right middle cerebral arteries in the subgroup of AD patients, whereas with the dose of 720 mg/kg this increase was only observed in the left side. Patients treated with anapsos (360 mg/day) showed a decrease in relative delta power and an increase in relative theta and alpha brain bioelectrical activity frequencies, indicating an acceleration of the EEG pattern. The present results show that anapsos (360 mg/day) improves cognitive performance, cerebral blood perfusion and brain bioelectrical activity in patients with senile dementia. These effects of anapsos were more marked in demented patients with mild mental deterioration and/or with dementia of the Alzheimer type.
本研究旨在评估两剂阿纳普索斯与安慰剂相比，对轻度至中度血管性和阿尔茨海默型老年痴呆患者认知能力、脑生物电活动模式和脑血流动力学参数的影响。45例年龄在73.8±7.6岁（范围56 - 89岁）的轻度至中度老年痴呆（全球衰退量表：3 - 5期）患者，其中血管性痴呆（VD；n = 22）或阿尔茨海默型痴呆（AD；n = 23），被纳入一项双盲随机安慰剂对照临床试验。经过2周的药物洗脱期后，患者接受安慰剂（n = 15；年龄72.7±7.5岁）、360毫克/天的阿纳普索斯（n = 15；年龄75.5±7.2岁）或720毫克/天的阿纳普索斯（n = 15；年龄73±7.7岁）治疗4周（28天）。在基线和4周双盲治疗期结束后，分别用阿尔茨海默病认知评定量表（ADAScog）、脑图谱和经颅多普勒超声评估认知能力、脑生物电活动功率和大脑中动脉的血流动力学。接受360毫克/天阿纳普索斯治疗的患者在治疗后认知能力有显著改善（ADAScog评分：p < 0.05），而接受安慰剂或720毫克/天阿纳普索斯治疗的患者未观察到这种改善。与安慰剂相比，阿纳普索斯（360毫克/天）使轻度老年痴呆患者（p < 0.01）和AD患者亚组（p < 0.05）的ADAScog评分有显著改善。阿纳普索斯（360毫克/天）还使AD患者亚组左右大脑中动脉的脑血流速度增加，而720毫克/千克剂量时仅在左侧观察到这种增加。接受阿纳普索斯（360毫克/天）治疗的患者相对δ功率降低，相对θ和α脑生物电活动频率增加，表明脑电图模式加速。目前的结果表明，阿纳普索斯（360毫克/天）可改善老年痴呆患者的认知能力、脑血流灌注和脑生物电活动。阿纳普索斯的这些作用在轻度智力衰退和/或阿尔茨海默型痴呆患者中更为明显。
