A Pharmacokinetic Study of Centella Asiatica in the Elderly

STUDY00017697

This study will measure the oral bioavailability and pharmacokinetics of known bioactive compounds from a standardized Centella asiatica water extract (CAW) product (CAP) in cognitively healthy elders.

2019-07-05

2019-11-30

2023-12-01

Active (not recruiting)

Early phase I

8

Inclusion Criteria: 1. Age 65-85, male and female 2. Sufficient English language skills to complete all tests 3. Sufficient vision and hearing to complete all tests 4. No known allergies to Centella asiatica or CAP components 5. Willingness to discontinue all botanical dietary supplements for one week prior to and during each study visit 6. Willingness to comply with a 48-hour low plant diet for each study visit 7. Absence of significant depression symptoms (Geriatric Depression Scale-15 score of \<12) 8. Body Mass Index (BMI) greater than 17 and less than 35 at screening 9. Non-demented, defined as Clinical Dementia Rating (CDR) score of zero and Mini Mental State Examination (MMSE) score \>28 10. General health status that will not interfere with the ability to complete the study Exclusion Criteria: 1. Current smoking, alcohol or substance abuse according to DSM-V criteria 2. Women who are pregnant, planning to become pregnant or breastfeeding 3. Men who are actively trying to conceive a child or planning to within three months of study completion 4. Severe aversion to venipuncture 5. Abnormal laboratory evaluation indicating asymptomatic and untreated urinary tract infection 6. Cancer within the last five years, with the exception of localized prostate cancer (Gleason Grade \<3) and non-metastatic skin cancers 7. Comorbid conditions such as diabetes mellitus, kidney failure, liver failure, hepatitis, blood disorders, clinical symptomatic orthostatic hypotension, and unstable or significantly symptomatic cardiovascular disease 8. Significant disease of the central nervous system such as brain tumor, seizure disorder, subdural hematoma, cranial arteritis, or clinically significant stroke 9. Major depression, schizophrenia, or other major psychiatric disorder defined by DSM-V criteria 10. Medications: sedatives (except those used occasionally for sleep), central nervous system active medications that have not been stable for two months (including beta blockers, cimetidine, SSRIs, SNRIs), anticoagulants (i.e. 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) 11. Diseases associated with dementia such as Alzheimer's disease, vascular dementia, normal pressure hydrocephalus or Parkinson's disease with a CDR score \>0.5 and MMSE score \<28 12. Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements

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2023-11-03