A Based on PEEG and PET Study of Anxiolytic Treatment to Improve Cognitive Function in Patients With Alzheimer Disease
概览
- 阶段
- 4 期
- 入组人数
- 30
- 主要终点
- Change of ADAS-cog total score
概览
简要总结
Objective: Evaluation the improvement of the cognitive function of tandospirone add-on treatment on patients with AD comorbid anxiety.
Number of Patients: 30
Methodology: Randomized, open-label, parallel-group
Assigned Interventions: Experimental: Tandospirone, 30-60 mg/d + Donepezil, 10 mg/d; Control group: Donepezil, 10 mg/d.
Effect Evaluation: Primary Outcome: Change from baseline in ADAS-cog total score at week 12; NPI scale total score at week 12;
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •55-80 years old (including 55 and 80), male or female, sufficient vision, hearing and general health to complete the follow-up and assessment;
- •Patients who were diagnosed with AD according to the DSM-IV;
- •MMSE score \> 10 and ≤ 24;
- •HAMA score \> 8;
- •HAMD score ≤ 7;
- •Brain CT or MRI supports the diagnosis of AD;
- •Provide written informed consent by the patient himself and his family member or guardian.
排除标准
- •Dementia from any other cause;
- •Brain MRI showed that the diameter of hyperintense lesions in T2-FLAIR sequences were larger than 5mm;
- •Patients with significant cardiac, pulmonary, hepatic, renal, or hematologic disease;
- •Any primary neurologic or psychiatric disease other than AD;
- •Mental disorders due to substance abuse;
- •Participation in other clinical studies within the last 30 days;
- •History of alcohol or substance abuse or dependence within the past year;
- •Pregnant or breastfeeding, or of child-bearing potential during the study.
研究组 & 干预措施
Experimental group
干预措施: Tandospirone Citrate (Drug)
Experimental group
干预措施: Donepezil Hydrochloride (Drug)
Control group
干预措施: Donepezil Hydrochloride (Drug)
结局指标
主要结局
Change of ADAS-cog total score
时间窗: week 12
Change from baseline in ADAS-cog total score at week 12
NPI scale total score
时间窗: week 12
NPI scale total score at week 12
次要结局
- HAMA total score(week 12)
- relative power(week 12)
- FAB score(week 12)
- the image of PET(week 12)
- MMSE score(week 12)
研究者
Enyan Yu
Secretary of Party Committee
Zhejiang Provincial People's Hospital