NCT03954613Unknown4 期
Evaluation of the Contribution of Regular Cognitive Exercises to Treatment in Patients With Alzheimer's Disease Receiving Donepezil, Memantine or Donepezil/Memantine Combination Therapy: Open-Labeled, Randomized, Phase IV, Superiority Study
Neutec Ar-Ge San ve Tic A.Ş1 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2020年10月15日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Change in MOCA total score
研究概览
简要总结
In this study, it is aimed to compare the effects of cognitive exercises applied on long-term internet environment to the cognitive level of patients who received donepezil, memantine or donepezil / memantin combination therapy.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 55-90 years old who were diagnosed with Alzheimer's Dementia and had no history of cerebrovascular disease during the last 6 months,
- •Patients without other neurodegenerative diseases and secondary dementia diagnoses,
- •Patients with MOCA score of between 13-18,
- •Patients with at least primary school graduation,
- •Patients who have had no CNS disease including trauma in the last year,
- •Patients without a diagnosis of psychiatric disease,
- •Patients with a tablet or PC with an internet connection,
- •Patients agreeing to perform BEYNEX daily activity at least 5 times per week,
- •Patients signing informed consent form.
排除标准
- •Patients who have hypersensitivity to study working drugs,
- •Psychotic patients,
- •Disabled patients with orthopedic dominant extremity,
- •Patients with ICU follow-up due to trauma in the last 6 months,
- •Patients with severe visual impairment or eye surgery,
- •Patients who refuse to sign the informed consent form.
结局指标
主要结局
Change in MOCA total score
时间窗: 6-months
MOCA: Montreal - Cognitive Assessment
次要结局
- Change in GDS total score(6-months)
- Change in ADAS-Cog total score(6-months)
- Change in CDR total score(6-months)
- Change in B-ADL total score(6-months)
- Change in clock drawing test(6-months)
研究者
研究点 (1)
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