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Preventing Cognitive Decline With Alternative Therapies
This study has been completed.
Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00010920
  Purpose

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 Intervention Phase
Dementia
Memory Disorders
Drug: Ginkgo Biloba Extract
Phase III

MedlinePlus related topics: Dementia Memory
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control
Official Title: Preventing Cognitive Decline With Alternative Therapies

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Study Start Date: September 1999
Estimated Study Completion Date: December 2004
Detailed Description:

See brief summary

  Eligibility

Ages Eligible for Study:   85 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00010920

Locations
United States, Oregon
Oregon Health Sciences University/Neurology
Portland, Oregon, United States, 97201
Sponsors and Collaborators
Investigators
Principal Investigator: Dr. Jeffrey Kaye Oregon Health and Science University
  More Information

Study ID Numbers: P50 AT000066-01P2, P50 AT000066-01
Study First Received: February 2, 2001
Last Updated: August 17, 2006
ClinicalTrials.gov Identifier: NCT00010920  
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Diseases
Neurologic Manifestations
Brain Diseases
Dementia
Neurobehavioral Manifestations
Memory Disorders
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009