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RECRUITINGPHASE1

Safety and Target Engagement of Centella Asiatica in Cognitive Impairment

NCT05591027•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.

Detailed 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

60 - 85 years

Sex

ALL

Healthy Volunteers

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 discontinue all botanical dietary supplements for one week prior to and during the study.
•Willingness to undertake multiple MRI scans
+4 more criteria

Exclusion Criteria

•Current smoking, alcohol, or substance abuse according to DSM-V criteria
•Women who are pregnant, planning to become pregnant, or breastfeeding
•Men who are actively trying to conceive a child or planning to within three months of study completion
•Severe aversion to venipuncture
•Abnormal labs indicating asymptomatic and untreated urinary tract infection
•Cancer within the last five years, with the exception of localized prostate cancer (Gleason Grade \< 3) and non-metastatic skin cancers
•Comorbid conditions such as type I diabetes mellitus, poorly controlled type II diabetes mellitus (HbA1c \> 7%), kidney failure, liver failure, hepatitis, blood disorders, clinical symptomatic orthostatic hypotension, and unstable or significantly symptomatic cardiovascular disease
•Significant disease of the Central Nervous System (CNS) such as brain tumor, seizure disorder, subdural hematoma, cranial arteritis, or clinically significant stroke
•Major depression, schizophrenia, or other major psychiatric disorder defined by DSM-V criteria
•Medications: anti-epileptics, sedatives, amitriptyline, anticoagulants (e.g., warfarin), investigational drugs used within five half-lives of baseline visit, systemic corticosteroids, neuroleptics, anti-Parkinsonian agents, narcotic analgesics, nicotine (tobacco, patches, gum, lozenges, etc.), Cannabis sativa (herb or edibles), beta blockers and anti-depressant medications that have not been at stable dosage for two months (including SSRIs, SNRIs)
+5 more criteria

Locations (1)

Oregon Health & Science University

Portland, Oregon, United States

Key Dates

Start Date

December 1, 2022

Primary Completion Date

November 30, 2025

Completion Date

March 31, 2026

Last Updated

April 11, 2025

Enrollment

ESTIMATED participants

Conditions

Mild Cognitive ImpairmentAlzheimer's Disease

Interventions

Centella asiatica product

DRUG

Placebo

DRUG

Contacts

Amala Soumyanath, PhD

CONTACT

503-494-6878 soumyana@ohsu.edu

Lucy Allison, MS

CONTACT

503-418-8197 allisolu@ohsu.edu

Sense4Safety Intervention

NCT07220668

Mild Cognitive Impairment

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RECRUITINGPHASE2/PHASE3

ACP-204 in Adults With Alzheimer's Disease Psychosis

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Alzheimer's Disease Psychosis

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RECRUITING

Lombard Cohort of Brain Health Services

NCT07457138

Subjective Cognitive Decline (SCD)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Safety and Target Engagement of Centella Asiatica in Cognitive Impairment

Inclusion Criteria

Exclusion Criteria

Sense4Safety Intervention

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