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临床试验/NCT03611439
NCT03611439已完成不适用

Effects of an 8 Component Botanical Supplement on Mild and Moderate Alzheimer's Patients

Genescient Corporation0 个研究点目标入组 50 人开始时间: 2013年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
主要终点
Change From Baseline Mini Mental State Exam (MMSE) Scores

研究概览

简要总结

This placebo-controlled, double blind study evaluates the treatment effects of adding a multi-pathway botanical dietary supplement (ReBuilder) to the standard treatment regimens of subjects diagnosed with mild or moderate stage Alzheimer's Disease. The objective of the study is to determine if mild and moderate AD patients exhibit improved or stabilized cognitive function when this supplement is added to maximum tolerated doses of their standard treatments.

详细描述

Currently, there is no treatment that can stop the progression of Alzheimer's Disease. The investigators in this study have used transgenic Drosophila melanogaster models and machine learning to develop an eight component botanical mixture (Geneaire™* ReBuilder™) that targets multiple genetic pathways involved in brain aging and dementia that are homologous between Drosophila and humans.

While beta-amyloid plaques and phosphorylated-tau tangles are diagnostic for AD, the cause(s) of their soluble precursors that kill neurons has not been determined. The majority of AD patients are diagnosed after 60 years of age. Many studies point to aging related processes like inflammation, neural vascular damage, neural stress, altered cell metabolism, inefficient cellular autophagy, microglial dysfunction, mitochondrial dysfunction, and poor diet as potential causal factors in the decline of brain function over the decades that precede an actual AD diagnosis. AD is a multifaceted pathology involving many biochemical pathways and thus a multifaceted therapeutic approach may prove beneficial.

The goal of this study was to test ReBuilder on human cognitive function. During the 12-month pilot study, the subjects were evaluated quarterly on the Mini Mental State Exam (MMSE), Alzheimer's Disease Cooperative Study's Activities of Daily Living (ADCS-ADL), and the Clinical Dementia Rating Sum of Boxes (CDR-SB).

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

randomized, double blind

入排标准

性别
All
接受健康志愿者

入选标准

  • Diagnosed mild or moderate Alzheimer's Disease

排除标准

  • History of heart disease
  • History of heart attack
  • History of cancer
  • History of stroke or transient ischemic attack

研究组 & 干预措施

ReBuilder Actives

Active Comparator

Subjects take one 650 mg capsule by mouth twice a day for 12 months.

干预措施: ReBuilder (Dietary Supplement)

ReBuilder Placebo

Placebo Comparator

Subjects take one placebo capsule by mouth twice a day for 12 months.

干预措施: Placebo (Dietary Supplement)

结局指标

主要结局

Change From Baseline Mini Mental State Exam (MMSE) Scores

时间窗: Change from baseline MMSE at 12 months

dementia questionnaire

Change From Baseline Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Scores

时间窗: Change from baseline ADCS-ADL at 12 months

daily living activity questionnaire

Change From Baseline Clinical Dementia Rating Sum of Boxes (CDR-SB) Scores

时间窗: Change from baseline CDR-SB at 12 months

dementia assessment

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

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