Effects of an 8 Component Botanical Supplement on Mild and Moderate Alzheimer's Patients
Primary Purpose
Alzheimer Disease, Alzheimer Dementia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ReBuilder
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
ReBuilder Actives
ReBuilder Placebo
Arm Description
Subjects take one 650 mg capsule by mouth twice a day for 12 months.
Subjects take one placebo capsule by mouth twice a day for 12 months.
Outcomes
Primary Outcome Measures
Change From Baseline Mini Mental State Exam (MMSE) Scores
dementia questionnaire
Change From Baseline Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Scores
daily living activity questionnaire
Change From Baseline Clinical Dementia Rating Sum of Boxes (CDR-SB) Scores
dementia assessment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03611439
Brief Title
Effects of an 8 Component Botanical Supplement on Mild and Moderate Alzheimer's Patients
Official Title
Effects of an 8 Component Botanical Supplement on Mild and Moderate Alzheimer's Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 1, 2013 (Actual)
Primary Completion Date
December 25, 2015 (Actual)
Study Completion Date
December 25, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genescient Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Alzheimer Dementia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized, placebo-controlled, double blind study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
randomized, double blind
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ReBuilder Actives
Arm Type
Active Comparator
Arm Description
Subjects take one 650 mg capsule by mouth twice a day for 12 months.
Arm Title
ReBuilder Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects take one placebo capsule by mouth twice a day for 12 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
ReBuilder
Other Intervention Name(s)
MX100A, Memex+
Intervention Description
8-component botanical dietary supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Inactive Placebo Capsule
Primary Outcome Measure Information:
Title
Change From Baseline Mini Mental State Exam (MMSE) Scores
Description
dementia questionnaire
Time Frame
Change from baseline MMSE at 12 months
Title
Change From Baseline Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Scores
Description
daily living activity questionnaire
Time Frame
Change from baseline ADCS-ADL at 12 months
Title
Change From Baseline Clinical Dementia Rating Sum of Boxes (CDR-SB) Scores
Description
dementia assessment
Time Frame
Change from baseline CDR-SB at 12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Effects of an 8 Component Botanical Supplement on Mild and Moderate Alzheimer's Patients
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