Clinical trial NCT03611439: 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
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Alzheimer Dementia
Lead sponsor: Genescient Corporation
Sponsor class: INDUSTRY
First posted: 2018-08-02
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized, placebo-controlled, double blind study
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Change From Baseline Mini Mental State Exam (MMSE) Scores
timeFrame: Change from baseline MMSE at 12 months
measure: Change From Baseline Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Scores
timeFrame: Change from baseline ADCS-ADL at 12 months
measure: Change From Baseline Clinical Dementia Rating Sum of Boxes (CDR-SB) Scores
timeFrame: Change from baseline CDR-SB at 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: