Non-pharmacological Intervention for Preclinical Alzheimer's Disease
关键词
抽象
描述
Currently, there has been no effective therapy for Alzheimer's disease (AD). Functional food is now considered as a potentially non-pharmacologic intervention and supplementation of functional food may positively affect cognitive function for patients with AD. However, there are few existing studies involving the role of mixed functional foods with multiple compositions on cognition and neuroimaging biomarkers for subjective cognitive decline (SCD).
Sixty participants with SCD will be recruited in this three-month, randomized, double-blind, placebo-controlled trial. Each group had thirty participants. Participants in the functional food group will take mixed functional foods for three months and those in the placebo group will take placebo. After that, the investigators will investigate the changes of memory measures, which is the primary outcome. Furthermore, based on the neuroimaging technique of functional near-infrared spectroscopy (fNIRS), the regulatory mechanism of mixed functional foods in intervening SCD will be revealed from the perspective of altered brain functional activity.
In conclusion, these results are beneficial for understanding the therapeutic effect of mixed functional foods as a non-drug therapy for preclinical AD and further elucidating the potential brain mechanism, which are of great values in solving scientific and clinical practice issues.
日期
| 最后验证: | 01/31/2020 |
| 首次提交: | 02/15/2020 |
| 提交的预估入学人数: | 02/18/2020 |
| 首次发布: | 02/20/2020 |
| 上次提交的更新: | 02/18/2020 |
| 最近更新发布: | 02/20/2020 |
| 实际学习开始日期: | 03/31/2019 |
| 预计主要完成日期: | 08/30/2019 |
| 预计完成日期: | 12/30/2019 |
状况或疾病
干预/治疗
Dietary Supplement: Mixed functional foods group with SCD
Dietary Supplement: Placebo group with SCD
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: Mixed functional foods group with SCD Thirty participants in this group will take mixed functional foods for three months. | Dietary Supplement: Mixed functional foods group with SCD In this project, taking the method of random, double blindness and control, participants in the mixed functional foods group will take functional foods with main compositions of ginsenoside, green tea polyphenols and marine collagen peptide for three months. After that, neuropsychological tests and neuroimaging biomarkers will be compared between functional food group and placebo group. |
| Placebo Comparator: Placebo group with SCD Thirty participants in this group will take placebo for three months. | Dietary Supplement: Placebo group with SCD In this project, taking the method of random, double blindness and control, participants in the placebo group will take placebo for three months. After that, cognitive changes and neuroimaging biomarkers will be compared between functional food group and placebo group. |
资格标准
| 有资格学习的年龄 | 50 Years 至 50 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 50-79 years old, right-handed and Mandarin-speaking subjects; - self-experienced persistent decline in cognitive capacity in comparison with a previously normal status and unrelated to an acute event; - normal age-adjusted, gender-adjusted and education-adjusted performance on standardised cognitive tests; - concerns (worries) associated with memory complaint; - failure to meet the criteria for MCI or dementia Exclusion Criteria: - a history of stroke; - major depression (Hamilton Depression Rating Scale score > 24 points); - other central nervous system diseases that may cause cognitive impairment, such as Parkinson's disease, tumors, encephalitis and epilepsy; - cognitive impairment caused by traumatic brain injury; - systemic diseases, such as thyroid dysfunction, syphilis and HIV; - a history of psychosis or congenital mental growth retardation. |
结果
主要结果指标
1. Changes of Auditory Verbal Learning Test (AVLT) score [Three months]
次要成果指标
1. FNIRS-based brain functional activity changes [Three months]
