Randomized Trial of a Nutritional Supplement in Alzheimer's Disease

NCT00678431 | Completed Phase 3

• 1 other identifier: 0553-06-071
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease; Dementia; Nutritional Supplement; Resveratrol

Outcome Measures

Primary Outcomes (1)

• Alzheimer Disease Assessment Scale (ADAScog)

  one year

Secondary Outcomes (1)

• CGIC

  one year

Study Arms (2)

Arm 1

PLACEBO COMPARATOR

Liquid placebo

Dietary Supplement: Placebo

Arm 2

EXPERIMENTAL

Liquid Resveratrol with Glucose, and Malate

Dietary Supplement: Resveratrol with Glucose, and Malate

Interventions

Resveratrol with Glucose, and Malate DIETARY_SUPPLEMENT

Dietary supplement delivered in grape juice

Arm 2

Placebo DIETARY_SUPPLEMENT

Liquid placebo

Arm 1

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• years of education, or work history sufficient to exclude mental retardation

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
• 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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead
• Alzheimer's Association: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (1)

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468, United States

Location

Related Publications (1)

• Zhu CW, Grossman H, Neugroschl J, Parker S, Burden A, Luo X, Sano M. A randomized, double-blind, placebo-controlled trial of resveratrol with glucose and malate (RGM) to slow the progression of Alzheimer's disease: A pilot study. Alzheimers Dement (N Y). 2018 Nov 9;4:609-616. doi: 10.1016/j.trci.2018.09.009. eCollection 2018.

  PMID: 30480082 DERIVED

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Interventions

Resveratrol; Glucose; malic acid

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Mary Sano, PhD

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2008
• First Posted: May 15, 2008
• Study Start: January 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: June 1, 2011
• Last Updated: November 15, 2012

Record last verified: 2012-11

Locations

US (1)