Preventing Cognitive Decline With Alternative Therapies
Primary Purpose
Dementia, Memory Disorders
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ginkgo Biloba Extract
Sponsored by
About this trial
This is an interventional prevention trial for Dementia
Eligibility Criteria
Inclusion Criteria: Can identify a collateral informant who has frequent contact with the subject No memory complaints compared to others of same age group and has not sought attention for concerns about memory or cognition Normal memory function defined by an education-adjusted score on the Logical Memory Subscale of the Wechsler Memory Scale-Revised Mini-Mental State Examination Score >23 Clinical Dementia Rating (CDR) of zero
Sites / Locations
- Oregon Health Sciences University/Neurology
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00010920
First Posted
February 2, 2001
Last Updated
August 17, 2006
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00010920
Brief Title
Preventing Cognitive Decline With Alternative Therapies
Official Title
Preventing Cognitive Decline With Alternative Therapies
Study Type
Interventional
2. Study Status
Record Verification Date
August 2006
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
5. Study Description
Brief Summary
Preventing dementia is an important goal for our aging population. This proposal is an initial 42 months study of the effect of standardized ginkgo biloba extract (GBE) on preventing or delaying cognitive decline in people age 85 years or older (the oldest old). The study focuses on the oldest old who present a distinct advantage for primary prevention studies because of their particularly high risk for developing mild cognitive impairment (MCI), a precursor to dementia. Because this is a population that has previously been out of the mainstream for use of alternative medicine, the safety of GBE in this age group will also be tested in this study. The study is randomized, placebo controlled and double blind. Approximately 200 elderly cognitively healthy subjects will be enrolled and followed for detection of conversion to MCI. This pilot study is viewed as a necessary first step in order to demonstrate that GBE, an alternative or complementary therapy, has a disease modifying effect on the brain, distinct from a symptomatic effect. The study will test the feasibility of the randomized start design, a trial design proposed as a method for discerning brain- or disease- modifying from symptomatic effects. The magnitude of biological effect of the treatments will also be assessed with volumetric quantitative MRI, a complementary means of confirming whether there is a brain modifying effect (measured as a decrease in brain volume loss with treatment). Peripheral markers of oxidation status will measure possible anti-oxidant effects of GBE.
Detailed Description
See brief summary
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Memory Disorders
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ginkgo Biloba Extract
10. Eligibility
Sex
All
Minimum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Can identify a collateral informant who has frequent contact with the subject
No memory complaints compared to others of same age group and has not sought attention for concerns about memory or cognition
Normal memory function defined by an education-adjusted score on the Logical Memory Subscale of the Wechsler Memory Scale-Revised
Mini-Mental State Examination Score >23
Clinical Dementia Rating (CDR) of zero
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Jeffrey Kaye
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health Sciences University/Neurology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
12. IPD Sharing Statement
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Preventing Cognitive Decline With Alternative Therapies
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