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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
Genescient Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 17, 2018
    Last Updated
    July 26, 2018
    Sponsor
    Genescient Corporation
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    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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