Safety and Target Engagement of Centella Asiatica in Cognitive Impairment

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Mild Cognitive Impairment, Alzheimer's Disease

In brief

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 facts

Study ID: NCT05591027
Run by: Oregon Health and Science University
People needed: 48
Starts: 2022-12-01
Expected to finish: 2026-03-31
Last updated by the study team: 2025-04-11

Who can join

Age: 60 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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)

Where it is running

Oregon Health & Science University — Portland, Oregon, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.