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P4‐172: DELAYED‐START ANALYSES OF SOLANEZUMAB PHASE 3 EXPEDITION STUDIES IN MILD ALZHEIMER'S DISEASE
Author(s) -
LiuSeifert Hong,
Andersen Scott,
Holdridge Karen,
Siemers Eric
Publication year - 2014
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.2014.05.1689
Subject(s) - placebo , medicine , disease , randomized controlled trial , pathology , alternative medicine
institutionalization, and high costs. Exercise studies in AD are just emerging and have produced conflicting findings on cognitive outcomes, largely due to low levels of exercise, poor delivery of aerobic exercise, and lack of controls. Methods: This randomized controlled trial (RCT) will investigate the effects of a novel 6-month, individualized, moderate-intensity stationarycycling intervention on cognition and hippocampal volume in communitydwelling older adults with mild-to-moderate AD. Ninety subjects will be randomized to the 6-month cycling intervention or attention control (sham exercise) groups using permuted blocks of 3 and 6 subjects randomly and a 2:1 allocation ratio, and followed for another 6months (see Figure 1). A combined heart rate reserve and perceived exertionmethod shown to be feasible and reliable in our preliminary studies will be used to prescribemoderate intensity exercise. Cognition will be measured by the AD Assessment Scale-Cognition (ADAS-Cog) at baseline, 3, 6, 9, and 12 months. Hippocampal volume will be measured by magnetic resonance imaging (MRI) at baseline, 6, and 12 months. The sample size will give us 80% power to detect at least a 2.5-point difference in within-group changes in ADAS-Cog at 6 months for the intervention group. Results: This study is funded by the National Institutes of Health’s National Institute on Aging (NIA) from 8/1/2013 to 7/31/2018, and is currently enrolling. Findings from the study will determine the immediate and long-term effects of the cycling intervention on cognition and hippocampal volume in AD over 1 year. Conclusions: This study is testing a rigorously-designed and delivered moderate-intensity of aerobic exercise intervention in a clinical AD population. Findings will provide important data to address the critical gap in knowledge of the therapeutic effects of aerobic exercise in AD and offer a potentially effective treatment for AD.