Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010803
Status:
COMPLETED
Last Update Posted:
2013-03-14
First Post:
2001-02-02
Brief Title:
Ginkgo Biloba Prevention Trial in Older Individuals
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Ginkgo Biloba Prevention Trial in Older Individuals
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will determine the effect of 240mgday Ginkgo biloba in decreasing the incidence of dementia and specifically Alzheimers disease AD slowing cognitive decline and functional disability reducing incidence of cardiovascular disease and decreasing total mortality
Detailed Description:
Participants will be studied in a randomized trial of 240 mg of Ginkgo biloba as compared to placebo in healthy men and women at least 75 years old The trial will last approximately 8 years The intervention will be considered unsuccessful in those participants who succumb to dementia including Alzheimers Disease and vascular dementia There are four clinical centers Pittsburgh PA Hagerstown MD Winston-Salem NC and Sacramento CA and a Coordinating Center at the University of Washington Seattle There will be a clinic visit every 6 months to determine morbidity mortality and change in cognition that will include repeat of ADAS CDR and 10 battery neuropsychological evaluation and informant interview The primary endpoint is dementia specifically Alzheimers disease secondary endpoint will include the incidence of vascular disease changes in cognitive function scores over time total mortality and changes in functional status The diagnosis of dementia will be based on neuropsychological testing neurological exam MRI functional measurements and review by a central adjudication committee and classified by DSM IV NINCDS criteria and ADRTC criteria for vascular disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None