Alzheimer Disease (AD) is a progressive brain disease generally known as senile dementia. Our proposed study will establish safety and pharmacokinetics of Meganatural-AZ GSPE in AD subjects. As secondary measures, we will also provide the essential human data to guide the design of future studies to test the efficacy of GSPE in mitigating cognitive deterioration in AD patients.
This study aims to establish the safety and pharmacokinetics of Meganatural-Az® GSPE in subjects with Alzheimer's disease. As a secondary goal, clinical and biomarker indices of therapeutic efficacy will also be evaluated. The proposed study will provide the essential human data necessary to guide the design of future studies testing the efficacy of GSPE in mitigating cognitive deterioration in AD patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
10
Meganatural-Az® doses: 30mg / day for 2 weeks; 4 weeks of 600 mg/day, 4 weeks 1000mg / day
Subjects receive capsules identical in appearance to the active agent with the same incremental schedule
Mount Sinai Alzheimer's Disease Research Center
New York, New York, United States
pharmacokinetic analysis
the pharmacokinetics and effects of Meganatural-Az® on tau and abnormally phosphorylated tau CSF concentrations
Time frame: up to 22 months
primary safety evaluations
adverse effects reporting
Time frame: up to 22 months
AD Biomarkers
β-amyloid (Aβ) in plasma and in cerebral spinal fluid (CSF) specimens
Time frame: up to 22 months
cognitive and functional assessments
cognitive and functional assessments including the ADAS-cog, ADCS CGIC, MMSE, and ADL.
Time frame: up to 22 months
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