Health Status and Quality of Life in the Elderly

Exploratory, Double-blind, Randomized, Placebo Controlled Study of AMP-886 in the Elderly

The study is designed to investigate the effect of AMP886 (alpha-tocotrienol) on health status and quality of life measures, cognitive functioning, oxidative stress, inflammation markers and other symptoms effects on skin, sleep and vision in the elderly.

Inclusion Criteria:

• Males and females 65-85 years old
• ECOG Performance score 0 to 1
• Body mass index 22-30 kg/m2
• Body weight >60 kg
• Habit to consume standard breakfast like toast, bread, butter/margarine, eggs, bacon, cereals with milk
• Comply with protocol and likely to be compliant with prescribed product

Exclusion Criteria:

• Renal insufficiency or failure at screening
• Current or previous positive documented history of any chronic inflammatory state including chronic infection, arthritis, or collagen vascular disorder.
• Comorbid medical conditions
• Use of prescription medication for chronic conditions
• Use of hormone replacement therapy (with the exception of levothyroxine)
• Uncontrolled hypertension
• Use of hemostatic agents
• Hemorrhagic disorder and/or coagulation disorder
• Clinically important bleeding within 90 days prior to screening visit
• Fat malabsorption syndromes
• Constipation and/or abdominal pain/discomfort that require dietary supplements or medical therapy
• History of smoking within 1 year prior to visit 1.