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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: Completed Phase 3 study, sponsored by US Department of Veterans Affairs.
NCT00678431 is a Phase 3 study that has completed, run by US Department of Veterans Affairs. The registered enrollment target is 27 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00678431 record still lists
NCT00678431 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00678431 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00678431's enrollment target sits among peer trials
27 1936th of 2000 higher than 64 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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