Preventing Cognitive Decline With Alternative Therapies
Status:
Completed
Trial end date:
2004-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
National Center for Complementary and Integrative Health (NCCIH)