Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT00010920 · ClinicalTrials.gov registry record · Phase 3

Preventing Cognitive Decline With Alternative Therapies

A Phase 3 study of Dementia and Memory Disorders, sponsored by National Center for Complementary and Integrative Health (NCCIH).

Completed
Registry status
Phase 3
Development phase
1
Study location

NCT00010920 is a Phase 3 study of Dementia and Memory Disorders that has completed, run by National Center for Complementary and Integrative Health (NCCIH). The trial reports 1 study location across 1 state.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT00010920, a Phase 3 study of Dementia and Memory Disorders, has completed, sponsored by National Center for Complementary and Integrative Health (NCCIH).

COMPLETED
Registry status
Phase 3
Development phase
1
Study location

Study 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.

Interventions

  • DRUG Ginkgo Biloba Extract

Study Locations (1)

Oregon

  • Oregon Health Sciences University/Neurology - Portland

Trial Details

FieldValue
Start Date 1999-09
Est. Completion 2004-12
Phase Phase 3

What the Registry Record Tells You About NCT00010920

The ClinicalTrials.gov registry entry for NCT00010920 describes a study currently listed as completed, categorized as Phase 3. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is National Center for Complementary and Integrative Health (NCCIH), which has 203 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Dementia appearing as the primary indexed condition, and to 1 intervention - of which Ginkgo Biloba Extract is the first listed.

NCT00010920 reports 1 study location spanning 1 distinct geographic area - top geographies include Oregon.

Frequently Asked Questions

What is clinical trial NCT00010920 about?

NCT00010920 is a clinical study titled "Preventing Cognitive Decline With Alternative Therapies". 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 w...

What is the current status of trial NCT00010920?

This trial is currently completed. It is a Phase 3 study. The study started on 1999-09. Estimated completion is 2004-12.

What conditions does trial NCT00010920 study?

This clinical trial studies the following conditions: Dementia, Memory Disorders.

What interventions are being tested in trial NCT00010920?

The interventions under investigation include: Ginkgo Biloba Extract (DRUG).

Who is sponsoring clinical trial NCT00010920?

This trial is sponsored by National Center for Complementary and Integrative Health (NCCIH), which has 203 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00010920 being conducted?

This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.