NCT05591027 Safety and Target Engagement of Centella Asiatica in Cognitive Impairment
| NCT ID | NCT05591027 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Oregon Health and Science University |
| Condition | Mild Cognitive Impairment |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2022-12-01 |
| Primary Completion | 2025-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 48 participants in total. It began in 2022-12-01 with a primary completion date of 2025-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 * Meet the National Institute of Aging - Alzheimer's Association core clinical criteria for MCI or probable AD dementia with a Clinical Dementia Rating score of 0.5-1 and Mini Mental State Examination score of 20-28 at screening and baseline * Participants who report a history of participative memory decline with gradual onset and slow progression over the last one year before screening MUST be corroborated by an informant. * Participants on acetylcholinesterase inhibitor or memantine therapy for AD must be on a stable dose for at least 12 weeks prior to baseline visit. * Participants must have an identified caregiver/study partner that can accompany participant to all study visits. 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) * Non-Alzheimer dementia such as vascular dementia, normal pressure hydrocephalus, or Parkinson's disease * MMSE score of \< 20 or \> 28 * Unwilling to maintain stable dosage of AD medications throughout study duration * Unwilling to maintain stable dosage of intervention throughout the course of the study * Contraindications to Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopic Imaging (MRSI) scans (some metal implants, pacemakers, claustrophobia)
Contact & Investigator
Amala Soumyanath, Ph.D
PRINCIPAL INVESTIGATOR
Oregon Health and Science University
Frequently Asked Questions
Who can join the NCT05591027 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, up to 85 Years, studying Mild Cognitive Impairment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05591027 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05591027 currently recruiting?
Yes, NCT05591027 is actively recruiting participants. Contact the research team at soumyana@ohsu.edu for enrollment information.
Where is the NCT05591027 trial being conducted?
This trial is being conducted at Portland, United States.
Who is sponsoring the NCT05591027 clinical trial?
NCT05591027 is sponsored by Oregon Health and Science University. The principal investigator is Amala Soumyanath, Ph.D at Oregon Health and Science University. The trial plans to enroll 48 participants.