Evaluating the effects of Centella asiatica on cognitive impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase I clinical trial investigates the safety and biological effects of a Centella asiatica water extract product in older adults aged 60-85 with mild cognitive impairment or Alzheimer's disease. Participants will receive either the Centella asiatica extract or a placebo daily for six weeks, with assessments conducted before and after the intervention. The study aims to measure biological signatures related to brain health, including neuronal viability and oxidative stress, while ensuring participant safety and tolerability.

Why it matters

Who can join: the full rules

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)

Where it's running

• Oregon Health & Science University
  Portland, Oregon, United States Recruiting

Study contacts

• Principal investigator: Amala Soumyanath, Ph.D — Oregon Health and Science University
• Study coordinator: Amala Soumyanath, PhD
• Email: soumyana@ohsu.edu
• Phone: 503-494-6878

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.