Preventing Cognitive Decline With Alternative Therapies

Dementia Clinical Trial

Official title:

Preventing Cognitive Decline With Alternative Therapies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00010920
• Other study ID #: P50 AT000066-01P2
• Secondary ID: P50AT000066-01
• Status: Completed
• Phase: Phase 3
• First received: February 2, 2001
• Last updated: August 17, 2006
• Start date: September 1999
• Est. completion date: December 2004

Study information

• Verified date: August 2006
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

See brief summary

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 85 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dementia
• Memory Disorders

Intervention

Drug:
• Ginkgo Biloba Extract

Locations

Country	Name	City	State
United States	Oregon Health Sciences University/Neurology	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States,