Safety and Target Engagement of Centella Asiatica in Cognitive Impairment
Part of paid clinical trials in Portland, Oregon.
- Sponsor
- Oregon Health and Science University
- Study ID
- NCT05591027
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Alzheimer's Disease
- Mild Cognitive Impairment
Eligibility Criteria
- Sex
- ALL
- Age
- 60 Years - 85 Years
- Healthy Volunteers
- Not accepted
Interventions
- Centella asiatica product — DRUGA 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.
- Placebo — DRUGA 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.
Study Details
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.
Key Dates
- Start date
- Dec 1, 2022
- Status verified
- Apr 2025
- Primary completion
- Nov 30, 2025
- Completion
- Mar 31, 2026
Study Design
- Enrollment
- 48 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Centella asiatica water extract product (CAP) 4gA sachet of containing 4g dried hot water extract (CAW) of Centella asiatica combined with inactive ingredients (excipients) will be dissolved in water and orally consumed daily as a drink for six weeks. Assessments will be collected at baseline and after six weeks of daily intervention.
- Placebo Comparator: PlaceboA sachet of inactive ingredients (excipients) identical in composition to those found in the active arm will be be dissolved in water and orally consumed daily for six weeks. Assessments will be collected at baseline and after six weeks of daily intervention.
Primary Outcome Measure
Change from baseline in brain N-acetylaspartate (NAA) to creatine (Cr) metabolite ratio (NAA/Cr) after 6 weeks on intervention. [ Time Frame: Baseline and 6 weeks ]
Central Contacts
- Amala Soumyanath, PhD503-494-6878
- Lucy Allison, MS503-418-8197
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Oregon Health & Science University | Portland | Oregon | 97239 |
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