Abstract
Disease-modifying treatments for Alzheimer's disease (AD) are currently unavailable and are the focus of an intensive research effort. We found vitamin B3, nicotinamide (NA), to significantly reduce pathology and improve behavior in AD transgenic mice. These results led us to conduct a double-blind, placebo-controlled randomized clinical trial of NA in mild to moderate AD.Following randomization, subjects received either NA (n = 15, 1500 mg twice daily) or placebo (n = 16) for 24 weeks. A battery of outcome measures were obtained at baseline and 6- week intervals and included the AD Assessment Scale-Cognitive Subscale, Clinician's Interview-Based Impression of Change Plus Caregiver Input, AD Cooperative Study-Activities of Daily Living Scale, and Clinical Dementia Rating Scale.
Highlights
Alzheimer’s disease (AD) is the leading cause of age-related dementia in the elderly [1]
The study was conducted in compliance with guidelines on human experimentation under protocols approved by the Institutional Review Boards of the University of California, Irvine, School of Medicine and the VA Long Beach Healthcare System (VALBHS)
Inclusion criteria for the study included a minimum age of 50 years, a diagnosis of mild to moderate dementia based on a MiniMental State Examination [MMSE] score between 13 and 25, brain imaging consistent with a diagnosis of probable AD based on published criteria [15], Hachinski Ischemic Score < 4, maintenance of stable dosing of cholinesterase inhibitors (ChEIs) and/or memantine for at least 30 days, and a caregiver/relative available who could assist with supplement administration and accompany the subject to all study visits
Summary
Alzheimer’s disease (AD) is the leading cause of age-related dementia in the elderly [1]. Progressive cognitive decline due to AD is associated with the accumulation, in selected brain regions, of betaamyloid and hyperphosphorylated tau into amyloid plaques and neurofibrillary tangles, respectively [1]. Over the years these major pathological features of AD have become the primary therapeutic targets of drug development strategies. We found vitamin B3, nicotinamide (NA), to significantly reduce pathology and improve behavior in AD transgenic mice. These results led us to conduct a double-blind, placebo-controlled randomized clinical trial of NA in mild to moderate AD
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