Safety and Target Engagement of Centella Asiatica in Cognitive Impairment
Oregon Health and Science University
Summary
This clinical trial is focused on determining whether biological signatures of target engagement by a Centella asiatica water extract product administered orally for 6 weeks can be measured in comparison to placebo. This study will also assess the safety and tolerability of the Centella asiatica water extract product.
Description
This Phase I study is a randomized, double-blind, placebo-controlled, clinical trial of 48 participants to evaluate safety, tolerability, and biological signatures of target engagement of brain neuronal viability, oxidative stress, and brain mitochondrial activity of a Centella asiatica water extract product (CAP) in older adults aged 60-85 years with mild cognitive impairment or mild Alzheimer's disease (AD). The intervention is taken orally daily for six weeks and pre and post assessments will be collected.
Eligibility
- Age range
- 60–85 years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria: * Age 60-85, male and female * Sufficient English language skills to complete all tests * Sufficient vision and hearing to complete all tests * No known allergies to Centella asiatica * Absence of significant depression symptoms (Geriatric Depression Scale-15 score of \< 5). * Total score of \<2 on the suicidal ideation subscale (measures 3, 7, 11, 12 and 14) of the Geriatric Depression Scale. * Body Mass Index (BMI) greater than 17 and less than 35 at screening * General health status that will not interfere with the ability to complete the study * Willingness to disconti…
Interventions
- DrugCentella asiatica product
A sachet of powdered product containing 4 g of a dried hot water extract of Centella asiatica as the active ingredient, combined with inactive ingredients (excipients) for color and taste dissolved in 10 oz of warm or room temperature water and consumed orally.
- DrugPlacebo
A sachet of powdered inactive ingredients (excipients) for color and taste identical in volume to those found in the active arm (CAP) dissolved in 10 oz of warm or room temperature water and consumed orally.
Location
- Oregon Health & Science UniversityPortland, Oregon