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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.
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.
Conditions Studied
Interventions
- DRUG Ginkgo Biloba Extract
Study Locations (1)
Oregon
- Oregon Health Sciences University/Neurology - Portland
Trial Details
| Field | Value |
|---|---|
| Start Date | 1999-09 |
| Est. Completion | 2004-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗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.
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Related
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