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Preventing Cognitive Decline With Alternative Therapies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00010920
Recruitment Status : Completed
First Posted : February 5, 2001
Last Update Posted : August 18, 2006
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

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.

Condition or disease Intervention/treatment Phase
Dementia Memory Disorders Drug: Ginkgo Biloba Extract Phase 3

Detailed Description:
See brief summary

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: Double
Primary Purpose: Prevention
Official Title: Preventing Cognitive Decline With Alternative Therapies
Study Start Date : September 1999
Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Information from the National Library of Medicine

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Ages Eligible for Study:   85 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00010920

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United States, Oregon
Oregon Health Sciences University/Neurology
Portland, Oregon, United States, 97201
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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Principal Investigator: Dr. Jeffrey Kaye Oregon Health and Science University
Layout table for additonal information Identifier: NCT00010920    
Other Study ID Numbers: P50AT000066-01P2 ( U.S. NIH Grant/Contract )
P50AT000066-01 ( U.S. NIH Grant/Contract )
First Posted: February 5, 2001    Key Record Dates
Last Update Posted: August 18, 2006
Last Verified: August 2006
Additional relevant MeSH terms:
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Memory Disorders
Cognitive Dysfunction
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Neurobehavioral Manifestations
Neurologic Manifestations