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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03611439
Enrollment
50
Registered
2018-08-02
Start date
2013-10-01
Completion date
2015-12-25
Last updated
2018-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Dementia, Alzheimer Disease

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).

Interventions

DIETARY_SUPPLEMENTReBuilder

8-component botanical dietary supplement

DIETARY_SUPPLEMENTPlacebo

Inactive Placebo Capsule

Sponsors

Genescient Corporation
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

randomized, double blind

Intervention model description

randomized, placebo-controlled, double blind study

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change From Baseline Clinical Dementia Rating Sum of Boxes (CDR-SB) ScoresChange from baseline CDR-SB at 12 monthsdementia assessment
Change From Baseline Mini Mental State Exam (MMSE) ScoresChange from baseline MMSE at 12 monthsdementia questionnaire
Change From Baseline Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) ScoresChange from baseline ADCS-ADL at 12 monthsdaily living activity questionnaire

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026