NCT04555655已完成早期 1 期
Trial of A Chicken Extract and Peptide Supplement for the Prevention of Cognitive Decline and Mechanisms of Action in Non-demented Elderly Adults: A Multicenter, Two-year, Three-arm, Randomized, Double-blind, Placebo-controlled Study
Brand's Suntory Asia6 个研究点 分布在 1 个国家目标入组 276 人开始时间: 2020年12月11日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 276
- 试验地点
- 6
- 主要终点
- Cognitive Function assessed by Alzheimer's Disease Composite Score (ADCOMS)
研究概览
简要总结
This trial investigates the effect of a chicken extract supplement and a peptide supplement on cognitive function and potential mechanisms of action of cognitive decline during ageing, among non-demented elderly adults using a three-arm, randomized, placebo-controlled clinical trial design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female at 55 - 75 years of age
- •Baseline cognition:
- •Normal cognition with feelings of cognitive decline (subjective cognitive decline) OR
- •Mild cognitive impairment (MCI+) with memory impairment
- •Agree to participate in the study and provide written informed consent
排除标准
- •Inadequate visual and auditory acuity to allow neuropsychological testing
- •Significant cerebrovascular disease
- •History of allergy to chicken meat
- •Diagnosis of Alzheimer's disease (AD) with dementia or any other dementia
- •Clinical dementia rating (CDR) score of > 0.5 at screening
- •Evidence of other neurological, psychiatric or physical illness that can produce cognitive deterioration per investigator's judgment
- •Inability or unwillingness to undergo PET scan
- •Current diagnosis or history of alcoholism or substance addiction
- •Regular use of any medication in the past 6 months that may affect cognitive functioning
- •Regular use of cognitive enhancing supplements in the past 6 months
- •Subjects with excessive blood donation or blood drawn prior to baseline
- •Persons with a history of cardiovascular disease or any other cardiovascular or cerebrovascular diseases which investigators deem unsuitable to participate in the clinical study.
结局指标
主要结局
Cognitive Function assessed by Alzheimer's Disease Composite Score (ADCOMS)
时间窗: 24 months
Change from baseline in Alzheimer's Disease Composite Score (ADCOMS). ADCOMS composite score is a weighted linear combination of the 12 items in the Wold's partial least squares (PLS) model. Composite scores range from 0.0 to a maximum of 1.97, where higher values indicate worse performance.
Florbetaben (18F) PET Scan Imaging
时间窗: 24 months
Change from baseline values in Florbetaben (18F) PET scan
次要结局
- Incidence of infections(24 months, reported at each study visit (4, 8, 12, 18 and 24 months))
- Cerebral blood flow measured with sonography(12 months & 24 months)
- Athens Insomnia Scale (AIS)(4, 8, 12, 18 and 24 months)
- Handgrip strength(12 months & 24 months)
- Blood myeloperoxidase (MPO) levels(12 months & 24 months)
- Ratio of plasma tau protein and amyloid-beta 42(24 months)
- Taiwanese Depression Questionnaire (TQD) score(4, 8, 12, 18 and 24 months)
- Blood pressure (systolic blood pressure and diastolic blood pressure)(4, 8, 12, 18 and 24 months)
- Fasting blood glucose level(4, 8, 12, 18 and 24 months)
- Alzheimer's Disease Composite Score (ADCOMS)(12 months)
- Blood inflammation biomarker levels (hs-CRP, ESR, TNF-α, IL-6)(12 months & 24 months)
- Short Form-36 (SF-36) Component and Scale Scores(4, 8, 12, 18 and 24 months)
研究者
研究点 (6)
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