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Preventing Cognitive Decline With Alternative Therapies

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00010920
First received: February 2, 2001
Last updated: August 17, 2006
Last verified: August 2006

February 2, 2001
August 17, 2006
September 1999
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Complete list of historical versions of study NCT00010920 on ClinicalTrials.gov Archive Site
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Preventing Cognitive Decline With Alternative Therapies
Preventing Cognitive Decline With Alternative Therapies

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.

See brief summary

Interventional
Phase 3
Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Prevention
  • Dementia
  • Memory Disorders
Drug: Ginkgo Biloba Extract
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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December 2004
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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
Both
85 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00010920
P50 AT000066-01P2, P50 AT000066-01
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National Center for Complementary and Alternative Medicine (NCCAM)
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Principal Investigator: Dr. Jeffrey Kaye Oregon Health and Science University
National Center for Complementary and Alternative Medicine (NCCAM)
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP