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OpenTrials
Completed

NCT Number: NCT03611439

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

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed mild or moderate Alzheimer's Disease

Exclusion criteria

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

Treatment and study plan

ReBuilder

Dietary Supplement

8-component botanical dietary supplement

Other names: MX100A, Memex+

Placebo

Dietary Supplement

Inactive Placebo Capsule

Primary outcomes

  1. Change From Baseline Mini Mental State Exam (MMSE) Scores

    Time frame: Change from baseline MMSE at 12 months

    dementia questionnaire

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

    Time frame: Change from baseline ADCS-ADL at 12 months

    daily living activity questionnaire

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

    Time frame: Change from baseline CDR-SB at 12 months

    dementia assessment

Sponsors and collaborators

Lead sponsor

Genescient Corporation

Industry

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 2, 2018
Registry last updated
Aug 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.