Randomized Trial of a Nutritional Supplement in Alzheimer's Disease

Completed · Phase 3 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT00678431

Run by

US Department of Veterans Affairs

People needed

27

Starts

2008-01-01

Expected to finish

2011-06-01

Last updated by the study team

2012-11-15

Who can join

Age: 50 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Consenting individuals as defined by IRB guidelines
• NINCDS/ADRDA criteria for probable AD
• Community dwelling
• Age: greater than or equal to 50 years
• MMSE between 12 and 26, inclusive
• Stable medical condition for 3 months prior to screening visit
• Stable doses of (non excluded) medications with central nervous system activity for 4 weeks prior to the screening visit (For cholinesterase inhibitors there should be no plan of dose escalation)
• Physically acceptable for this study as confirmed by medical history, physical exam, neurologic exam and clinical laboratory tests
• Supervision available for administration of study medications
• Study partner to accompany subject to all scheduled visits and complete informant-based assessments.
• Fluent in English or Spanish
• Modified Hachinski < 4
• CT or MRI since onset of memory impairment demonstrating absence of clinically significant focal lesion (One lacune in a non-critical brain region is acceptable)
• Able to complete baseline assessments
• 6 years of education, or work history sufficient to exclude mental retardation
• Able to ingest oral medication

You may not qualify if…

• Active liver disease or persistent elevation in serum transaminase
• Severe renal disease
• - Hx of diabetes mellitus (both insulin-dependent and non-insulin-dependent) or blood glucose >150 mg/dl
• Active neoplastic disease (skin tumors other than melanoma are not exclusionary; subjects with stable prostate cancer or other stable cancers may be included at the discretion of the PI (Sano))
• Use of another investigational agent within 2 months of the screening visit
• History of clinically significant stroke
• Current evidence or history in the past 2 years of seizures, head injury with loss of consciousness and/or immediate confusion after the injury
• Current DSM-IV criteria-based diagnosis for major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse.
• Blindness, deafness, language difficulties or any other disability which may interfere with testing ability
• In female subjects, no history of menopause
• Use of medications containing aluminum hydroxide, including anti-ulcer antacids such as Alternagel, Amphojel, Alu-tab, Maalox and Mylanta

Where it is running

• James J. Peters VA Medical Center, Bronx, NY — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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