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P4‐218: A phase I, double‐blind, placebo‐controlled, randomized, multiple dose study to evaluate the safety, tolerability, and pharmacokinetics of PF 04447943 in mild‐to‐moderate Alzheimer's disease subjects on stable donepezil therapy
Author(s) -
Evans Rebecca,
Nicholas Timothy,
Le Vu,
Martin William,
Martin David,
Schwam Elias
Publication year - 2011
Publication title -
alzheimer's and dementia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 6.713
H-Index - 118
eISSN - 1552-5279
pISSN - 1552-5260
DOI - 10.1016/j.jalz.2011.05.2241
Subject(s) - tolerability , donepezil , medicine , placebo , adverse effect , nausea , pharmacokinetics , dosing , anesthesia , pharmacology , dementia , disease , pathology , alternative medicine
ing established diets found a combination of nutrients may be more powerful than any single class of nutrients. Brain health related evidence was used to design a whole foods Memory Preservation Nutrition (MPN) program emphasizing synergistic contributions of increasing foods with various properties including anti-oxidant, anti-inflammatory attenuate insulin resistance and/or improve lipid balance. Poly-nutrient interventions for clinical research on AD and MCI were derived from the MPN, including the Memory Preservation Nutrition Supplement Program (MPNSP), and the Nutritional Supplement Combination Therapy (NSCT). The MPNSP consists of a phyto-nutrient powder comprised of 100% organic freeze-dried fruits and vegetables, spices, grains and probiotics; an amalgam of herbs and spices chosen for their reported anti-inflammatory properties; and cod liver oil. The NCST added to MPNSP a DHA-enriched fish oil and 2000 IU of vitamin D. Dr. Jon Valla’s Arizona-based team administered the MPNSP incorporated into standard mouse chow, to triply-transgenic mice known to develop features of AD with age and achieved promising results, especially with regard to improving mitochondrial function. Methods: The NSCT study is an open label Phase 1 clinical trial of a combination of over-the-counter nutritional supplements in 25 cognitively normal healthy older adults over an 8 month period including two months for titration to full dosage of the NCST, which comprises 19 pills. Blood and urine specimens, blood pressure, BMI measurements and FFQs will be taken at baseline, 5 and 8 months. Outcome biomarkers include: inflammation (C-RP, IL-6), blood glucose (HbA1c), lipids, oxidative stress (8OH2dG in urine), homocysteine, CoQ10, creatine and creatinine, neurotransmitters tryptophan and tyrosine, and metabolomic profiles in plasma. For adherence and bioavailability: vit Bs, Vit D, Vit E, Vit K, fatty acids & beta-carotene. Results: Recruitment started Spring 2010. Will report whether subjects were able to ingest 19 pills. Conclusions: Combination nutritional interventions for brain and body health may yield significant knowledge.