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Centella asiatica for Mild Cognitive Impairment and Alzheimer's Disease

This study is testing a product made from Centella asiatica, a plant, to see if it's safe and how it affects the brain in people aged 60-85 with mild cognitive impairment or mild Alzheimer's disease. You would take a powdered form of Centella asiatica or a placebo (an inactive substance that looks the same) dissolved in water daily for six weeks. Researchers will measure changes in a brain chemical called N-acetylaspartate (NAA) relative to creatine (Cr) to understand if the product is having an effect. The study is currently unclear on its recruitment status and plans to enroll 48 participants. To join, you need to be 60-85 years old, have good English, vision, and hearing, and no allergies to Centella asiatica or significant depression.

Study design
This is a Phase I, randomized, double-blind, placebo-controlled study with 48 participants.
What's involved
You would take an oral intervention daily for six weeks and complete assessments at the beginning and end of this period.
Compensation
Not stated in the trial record.
Follow-up
Participants are assessed at baseline and after 6 weeks of intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05591027

Safety and Target Engagement of Centella Asiatica in Cognitive Impairment

Recruiting
PHASE1Ages 60–85InterventionalTreatment
Oregon Health and Science University
~48 participants
Updated 2025-04-11 on ClinicalTrials.gov
What's tested:Centella asiatica productPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in brain N-acetylaspartate (NAA) to creatine (Cr) metabolite ratio (NAA/Cr) after 6 weeks on intervention.
Measured over Baseline and 6 weeks

Conditions

Mild Cognitive Impairment
Alzheimer's Disease

Explore related trials

Alzheimer's DiseaseMild cognitive disorder

Where it's being run

1 sites across 1 states
Oregon1

Study leadership

  • Amala Soumyanath, Ph.D · PRINCIPAL_INVESTIGATOR · Oregon Health and Science University
  • Joseph Quinn, MD · PRINCIPAL_INVESTIGATOR · Oregon Health and Science University

Who to contact

Amala Soumyanath, PhD
[email protected]
503-494-6878
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Change from baseline in brain N-acetylaspartate (NAA) to creatine (Cr) metabolite ratio (NAA/Cr) after 6 weeks on intervention.Baseline and 6 weeks

    N-acetylaspartate (NAA)/creatine (Cr) metabolite ratio (NAA/Cr) in the brain determined through 1H-Magnetic Resonance Spectroscopic Imaging of a single brain slice as an indicator of neuronal viability and mitochondrial activity.