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NCT00678431 · ClinicalTrials.gov registry record · Phase 3
Randomized Trial of a Nutritional Supplement in Alzheimer's Disease
A Phase 3 study, sponsored by US Department of Veterans Affairs.
- Completed
- Registry status
- Phase 3
- Development phase
- 27
- Enrollment target
NCT00678431 is a Phase 3 study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 27 participants.
The verdict
NCT00678431, a Phase 3 study, has completed, sponsored by US Department of Veterans Affairs.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 27 participants
- Enrollment target
Study Summary
Alzheimer's disease (AD), one of the leading causes of morbidity and mortality in the elderly is characterized by progressive cognitive decline and certain neuropathological features. Currently, there is great interest in the well-documented mitochondrial (oxidative) lesion in AD. Disturbed oxidative metabolism is a well described abnormality in AD. Several observational studies have shown that moderate consumption of wine is associated with a lower incidence of Alzheimer's disease (Truelsen et al., 2002; Luchsinger et al., 2004). Wine is enriched in antioxidant compounds with potential neuroprotective activities. In the early 1990s the presence of Resveratrol in red wine was detected where it is suspected to afford antioxidant and neuroprotective properties (Miller and Rice-Evans, 1995). Blass and Gordon (2004) have demonstrated positive effects in AD with an oral preparation of glucose, malate and resveratrol. Glucose is the physiological precursor of the substrates of oxidative metabolism in the brain, malate is a primer of the energy-providing Krebs-cycle. Glucose and malate therefore can provide reducing equivalents (electrons) to regenerate the reduced form of resveratrol, and do so under the normal regulation of brain cell metabolism. All three ingredients are classified by the FDA as Generally Recognized As Safe.
Interventions
- DIETARY_SUPPLEMENT Placebo
- DIETARY_SUPPLEMENT Resveratrol with Glucose, and Malate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2008-01 |
| Est. Completion | 2011-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00678431
The ClinicalTrials.gov registry entry for NCT00678431 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is US Department of Veterans Affairs, which has 632 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00678431 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00678431 about?
NCT00678431 is a clinical study titled "Randomized Trial of a Nutritional Supplement in Alzheimer's Disease". Alzheimer's disease (AD), one of the leading causes of morbidity and mortality in the elderly is characterized by progressive cognitive decline and certain neuropathological features. Currently, there is great interest in the well-documented mitochondrial (oxidative) lesion in AD. Disturbed oxidati...
What is the current status of trial NCT00678431?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 27 participants. The study started on 2008-01. Estimated completion is 2011-06.
What interventions are being tested in trial NCT00678431?
The interventions under investigation include: Placebo (DIETARY_SUPPLEMENT), Resveratrol with Glucose, and Malate (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00678431?
This trial is sponsored by US Department of Veterans Affairs, which has 632 total clinical trials registered on ClinicalTrials.gov.
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