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

Not Applicable

Completed

• Conditions: Alzheimer Dementia; Alzheimer Disease
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: ReBuilder

• Registration Number: NCT03611439
• Lead Sponsor: Genescient Corporation

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2013-10-01
• Primary Completion: 2015-12-25
• Study Completion: 2015-12-25
• Status Verified: 2018-07
• Study First Submitted: 2018-07-17
• Study First Submitted QC: 2018-07-26
• Last Update Submitted: 2018-07-26
• Study First Posted: 2018-08-02
• Last Update Posted: 2018-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ReBuilder Placebo	Placebo	Subjects take one placebo capsule by mouth twice a day for 12 months.
ReBuilder Actives	ReBuilder	Subjects take one 650 mg capsule by mouth twice a day for 12 months.

Primary Outcome Measures

Name	Time	Method
Change From Baseline Mini Mental State Exam (MMSE) Scores	Change from baseline MMSE at 12 months	dementia questionnaire
Change From Baseline Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Scores	Change from baseline ADCS-ADL at 12 months	daily living activity questionnaire
Change From Baseline Clinical Dementia Rating Sum of Boxes (CDR-SB) Scores	Change from baseline CDR-SB at 12 months	dementia assessment