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

July 26, 2018 updated by: Genescient Corporation
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ReBuilder Actives
Subjects take one 650 mg capsule by mouth twice a day for 12 months.
Dietary supplement: ReBuilder
8-component botanical dietary supplement
Other Names:
  • MX100A
  • Memex+
Placebo Comparator: ReBuilder Placebo
Subjects take one placebo capsule by mouth twice a day for 12 months.
Dietary supplement: Placebo
Inactive Placebo Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline Mini Mental State Exam (MMSE) Scores
Time Frame: Change from baseline MMSE at 12 months
dementia questionnaire
Change from baseline MMSE at 12 months
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
Change from baseline ADCS-ADL at 12 months
Change From Baseline Clinical Dementia Rating Sum of Boxes (CDR-SB) Scores
Time Frame: Change from baseline CDR-SB at 12 months
dementia assessment
Change from baseline CDR-SB at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genescient Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2013

Primary Completion (Actual)

December 25, 2015

Study Completion (Actual)

December 25, 2015

Study Registration Dates

First Submitted

July 17, 2018

First Submitted That Met QC Criteria

July 26, 2018

First Posted (Actual)

August 2, 2018

Study Record Updates

Last Update Posted (Actual)

August 2, 2018

Last Update Submitted That Met QC Criteria

July 26, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Genescient

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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