E-Mail karger@karger.com Methods in Neuroepidemiology Neuroepidemiology 2013;41:198–207 DOI: 10.1159/000354632 Preserving Cognition, Quality of Life, Physical Health and Functional Ability in Alzheimer’s Disease: The Effect of Physical Exercise (ADEX Trial): Rationale and Design Kristine Hoffmann   a Kristian S. Frederiksen   a Nanna Aue Sobol   b Nina Beyer   b Asmus Vogel   a Anja Hviid Simonsen   a Peter Johannsen   a Annette Lolk   c Ole Terkelsen   d Carl W. Cotman   e Steen G. Hasselbalch   a Gunhild Waldemar   a a  Memory Disorders Research Group, Danish Dementia Research Center, Department of Neurology, Copenhagen University Hospital Rigshospitalet, b  Musculoskeletal Rehabilitation Research Unit and Institute of Sports Medicine Copenhagen, Copenhagen University Hospital Bispebjerg, and c  Department of Clinical Quality, Capital Region of Denmark, Copenhagen, and d  Dementia Clinic, Odense University Hospital, Odense, Denmark; e  Institute for Memory Impairments and Neurological Disorders, University of California-Irvine, Irvine, Calif., USA ercise and a control group receiving usual care. We plan to recruit 192 patients with mild AD. The primary outcome measure is change from baseline in cognitive performance at 16 weeks (as measured by the Symbol Digit Modali- ties test). Conclusions: To our knowledge this is the first large-scale controlled study to investigate the effects of su- pervised moderate aerobic exercise on cognition in pa- tients with AD. Recruitment began in January 2012 and re- sults are expected to be available in 2014. We summarize the methodological challenges we and other studies have faced in this type of complex multicenter intervention with unique challenges to study design. © 2013 S. Karger AG, Basel Introduction Alzheimer’s disease (AD) is the most prevalent neuro- degenerative disorder worldwide, affecting more than 50% of patients with dementia. The clinical hallmarks of AD are progressive memory impairment and decreased Key Words Alzheimer’s disease · Clinical trial design · Cognition · Exercise · Intervention · Health-related quality of life · Physical function · β-Amyloid · Neuroimaging Abstract Background: Exercise is hypothesized to improve cognition, physical performance, functional ability and quality of life, but evidence is scarce. Previous studies were of short dura- tion, often underpowered and involving home-based light exercise programs in patients with undefined dementia. The aim of the ADEX (‘Preserving Cognition, Quality of Life, Phys- ical Health and Functional Ability in Alzheimer’s Disease: the Effect of Physical Exercise’) trial is to establish whether aero- bic exercise is effective in improving cognition as well as in reducing the prevalence of psychiatric symptoms among patients with Alzheimer’s disease (AD). Methods: The ADEX study is a multicenter, single-blind, randomized trial with two arms: an intervention group attending 16 weeks of con- tinuously supervised moderate-to-high intensity aerobic ex- Received: May 9, 2013 Accepted: July 22, 2013 Published online: October 15, 2013 Kristine Hoffmann Memory Disorders Research Group, Danish Dementia Research Group Department of Neurology, Copenhagen University Hospital Blegdamsvej 9, DK–2100 Copenhagen (Denmark) E-Mail kristine.hoffmann  @  regionh.dk © 2013 S. Karger AG, Basel 0251–5350/13/0414–0198$38.00/0 www.karger.com/ned Downloaded by: 198.143.37.97 - 2/6/2016 11:52:22 PM