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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03611439
Other study ID # Genescient
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2013
Est. completion date December 25, 2015

Study information

Verified date July 2018
Source Genescient Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 (Geneaireâ„¢* ReBuilderâ„¢) 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).


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date December 25, 2015
Est. primary completion date December 25, 2015
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
ReBuilder
8-component botanical dietary supplement
Placebo
Inactive Placebo Capsule

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Genescient Corporation

Outcome

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