Evaluation of the Efficacy and Safety of PRJ212 on Improving the Memory of Patients With Mild Severity Alzheimer's Disease: A 6-month Randomized, Double-blind and Placebo-controlled, Followed by a 6-month Open Label Extension Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Efficacy of PRJ212 versus placebo on the memory measured by Repeatable Battery for the Assessment of Neuropsychological Status (R-BANS).
研究概览
简要总结
A 6-month randomized, double-blind and placebo-controlled, followed by a 6-month open label extension study.
详细描述
Men and women from 60 to 85 years old with diagnosis of mild severity Alzheimer's disease, according to the diagnostic criteria established by the National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer's Disease and Related Disorders Associations (NINCDS-ADRDA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged from 60 to 85 years.
- •Patients with a diagnosis of probable or possible Alzheimer's disease according to the NINCDS-ADRDA.
- •Patients with mild Alzheimer's disease according to MMSE.
- •Patients with ability to ingest oral medication.
- •Patients able to undergo a MRI.
排除标准
- •Pregnant or breastfeeding women or planning a pregnancy during the study.
- •Patients and caregivers unwilling or unable to perform cognitive testing.
- •Patients taking part in an interventional clinical trial.
- •Patients who have a risk of non-compliance to the study procedures.
- •Patients with clinical or significant laboratory abnormalities.
- •Patients treated with concomitant treatment or food supplements which could interfere with evaluation criteria.
研究组 & 干预措施
PRJ212
PRJ212 is a nutritional product with active food ingredients.
干预措施: PRJ212 (Dietary Supplement)
Placebo
Placebo is like PRJ212 without active food ingredients.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Efficacy of PRJ212 versus placebo on the memory measured by Repeatable Battery for the Assessment of Neuropsychological Status (R-BANS).
时间窗: Comparison of the R-BANS score, from baseline to 6 months.
Efficacy of PRJ212 versus placebo on the memory measured by Wechsler Memory Scale (WMS).
时间窗: Comparison of the WMS score, from baseline to 6 months.
Efficacy of PRJ212 versus placebo on the memory measured by memory composite (R-BANS+WMS).
时间窗: Comparison of the total memory composite score, from baseline to 6 months.
次要结局
未报告次要终点