Actively Recruiting
Safety and Target Engagement of Centella Asiatica in Cognitive Impairment
Led by Oregon Health and Science University · Updated on 2025-04-11
48
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
Sponsors
O
Oregon Health and Science University
Lead Sponsor
A
Alzheimer's Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Safety and Target Engagement of Centella Asiatica in Cognitive Impairment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 60 to 85 years, 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 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 ability to complete the study
- Willingness to discontinue all botanical dietary supplements for one week prior to and during the study
- Willingness to undertake multiple MRI scans
- Meet National Institute of Aging - Alzheimer's Association core clinical criteria for mild cognitive impairment or probable Alzheimer's dementia with Clinical Dementia Rating score of 0.5-1 and Mini Mental State Examination score of 20-28
- History of gradual memory decline for at least one year corroborated by an informant
- Stable dose of acetylcholinesterase inhibitor or memantine therapy for at least 12 weeks prior to baseline if on these treatments
- Have an identified caregiver/study partner to accompany participant to all study visits
You will not qualify if you...
- Current smoking, alcohol, or substance abuse
- Women who are pregnant, planning pregnancy, or breastfeeding
- Men actively trying to conceive or planning to conceive within three months of study completion
- Severe aversion to venipuncture
- Untreated or asymptomatic urinary tract infection
- Cancer within the last five years except localized prostate cancer (Gleason Grade < 3) and non-metastatic skin cancers
- Comorbid conditions: type I diabetes, poorly controlled type II diabetes (HbA1c > 7%), kidney failure, liver failure, hepatitis, blood disorders, symptomatic orthostatic hypotension, unstable or symptomatic cardiovascular disease
- Significant central nervous system diseases including brain tumor, seizure disorder, subdural hematoma, cranial arteritis, or significant stroke
- Major psychiatric disorders such as major depression, schizophrenia
- Use of certain medications including anti-epileptics, sedatives, amitriptyline, anticoagulants, investigational drugs within five half-lives, systemic corticosteroids, neuroleptics, anti-Parkinsonian agents, narcotics, nicotine products, Cannabis, beta blockers, and unstable antidepressant dosages
- Non-Alzheimer dementia such as vascular dementia, normal pressure hydrocephalus, or Parkinson's disease
- Mini Mental State Examination score less than 20 or greater than 28
- Unwillingness to maintain stable dosages of Alzheimer's medications or study intervention throughout the study
- Contraindications to MRI or MRSI scans such as certain metal implants or claustrophobia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
Research Team
A
Amala Soumyanath, PhD
CONTACT
L
Lucy Allison, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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