Preventing Cognitive Decline With Alternative Therapies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

1999-09-30

Study Completion Date

2004-12-31

Brief Summary

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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

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See brief summary

Conditions

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Dementia Memory Disorders

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Ginkgo Biloba Extract

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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Dr. Jeffrey Kaye

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health Sciences University/Neurology

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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P50AT000066-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P50AT000066-01P2