Ignite Creation Date:
2024-05-06 @ 1:06 PM
Last Modification Date:
2024-10-26 @ 1:09 PM
Study NCT ID:
NCT03937908
Status:
TERMINATED
Last Update Posted:
2022-05-04
First Post:
2019-04-23
Brief Title:
Pharmacokinetics Centella Asiatica Product CAP in Mild Cognitive Impairment
Sponsor:
Oregon Health and Science University
Organization:
Oregon Health and Science University
Study Overview
Official Title:
A Pharmacokinetic Study of Centella Asiatica Product CAP in Elderly Participants With Mild Cognitive Impairment Receiving Cholinesterase Inhibitor Therapy
Status:
TERMINATED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Participant study visits not possible during COVID-19 pandemic Funder not able to support a continuation at some future date
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will measure the oral bioavailability and pharmacokinetics of known bioactive compounds from a standardized Centella asiatica water extract product CAP in mildly demented elders on cholinesterase inhibitor therapy Compound levels will be measured in human plasma and urine over 10 hours after acute oral administration of two doses of the botanical extract product The dose giving maximum plasma levels Cmaxclosest to those observed in the investigators mouse studies the area under the curve AUC0-12 as well as the rate of clearance t ½ of the known compounds and time of maximum concentration tmax will be identified These data will be used to inform decisions on the dosage and dosing frequency for future clinical trials
Detailed Description:
PRIMARY OBJECTIVES
1 To assess the bioavailability and rate of clearance of Centella asiatica derived compounds in mildly demented elders on cholinesterase inhibitor therapy through a pharmacokinetic study
2 To determine the acute tolerability of a Centella asiatica product in mildly demented elders on cholinesterase inhibitor therapy
OUTLINE
Participants will orally consume a single administration of a standardized Centella asiatica water extract product CAP Two doses 2g and 4g CAW will be administered on separate occasions at least two weeks apart The levels of known bioactive compounds present in Centella asiatica will be measured in human plasma and urine over 10 hours after administration of each of the doses
1 To assess the bioavailability and rate of clearance of Centella asiatica derived compounds in mildly demented elders on cholinesterase inhibitor therapy through a pharmacokinetic study
2 To determine the acute tolerability of a Centella asiatica product in mildly demented elders on cholinesterase inhibitor therapy
OUTLINE
Participants will orally consume a single administration of a standardized Centella asiatica water extract product CAP Two doses 2g and 4g CAW will be administered on separate occasions at least two weeks apart The levels of known bioactive compounds present in Centella asiatica will be measured in human plasma and urine over 10 hours after administration of each of the doses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R61AT009628 | NIH | None | httpsreporternihgovquickSearchR61AT009628 |