DECREASE: Decrease Cognitive Decline in Alzheimer’s Disease Through Occupational Therapy: A Randomized Controlled Phase III Trial Protocol
Authors:   Alberto Hurtado Medical School, Cayetano Heredia Peruvian University, Lima, Peru, Pacheco-Barrios Niels , Ramin-Wright Leandra ,   University of Basel, Basel, Switzerland, Zhong Sandra ,   AscenZion Neuromodulation Co., Singapore City, Singapore, Plaza Cecilia ,   Clinica Alemana de Santiago, Chile, Elhadi Aala ,   Rashid Hospital, Dubai, UAE, Stokvis Marion ,   Francisco Marroquín University, Guatemala, Guatemala, Barrios Alanna ,   Tecnologico de Monterrey, School of Medicine and Health Sciences, Monterrey, Nuevo Leon, Mexico, Kasakewitch João ,   BIDMC, Department of Surgery, Harvard Medical School, Boston, MA, USA, Rodriguez Gloria ,   University of Texas, Rio Grande Valley, USA, Alfaro Stefany ,   Universidad Nacional Mayor de San Marcos, Lima, Peru, Areas Guilherme ,   Physiology Science Department, Universidade Federal do Amazonas, Amazonas, Brazil, Batista Mariana ,   Cancer Institute of the State of São Paulo, Brazil, Brasil Lucas ,   Hospital Alemão Oswaldo Cruz, São Paulo, Brazil, Estrella Deborah ,   Federal University of Minas Gerais, Brazil, García Camila ,   Pontificia Universidad Católica Madre y Maestra, Dominican Republic, Hastor Hana ,   Berlin Institute of Health, Charité – Universitätsmedizin, Berlin, Germany, Medeiros Renata ,   Eurofarma, São Paulo, Brazil, Melo Vítor M. F. ,   Universidade Salvador, Brazil, Perez Luis ,   Hospital Guillermo Almenara Irigoyen, Lima, Peru, Ponce Cristina J. ,   Beth Israel Deaconess Medical Center, Boston, MA, USA, Roohani Siyer ,   Charité – Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt Universität zu Berlin, Rutes Nayara ,   Hospital Alemão Oswaldo Cruz, São Paulo, Brazil, Winter Jose ,   Facultad de Medicina, Universidad del Desarrollo, Clinica Alemana de Santiago, Chile, Yovera Elsa ,   National Institute of Health, Lima, Peru
Published: November 2023

Introduction: Alzheimer’s disease (AD) accounts for more than 80% of dementia cases worldwide and imposes a significant economic burden on the healthcare system. Currently, there is no cure for AD, and pharmacological treatments alleviate AD symptoms but fail to decrease cognitive decline. Occupational Therapy (OT) for AD patients targets symptoms without the side effects of drugs and may even play a disease-modifying role by preserving cognitive functions. The DECREASE trial aims to assess the effectiveness of a cognitive-based OT intervention amongst AD patients. Methods: The DECREASE Trial is a randomized, controlled, multicentric, phase III, superiority trial comparing the effect of OT and standard of care versus standard of care alone on cognition in AD patients. OT will entail a five-week group cognitive rehabilitation program with remote maintenance sessions until six months of follow-up. We will include 278 mild AD patients aged between 65 and 80. Changes in cognitive function between groups will be measured and compared by the ADAS-cog after six months. Discussion: The strengths of this OT program are that it is non-invasive, safe, highly standardized, and accessible to occupational therapists and caretakers worldwide. There is broad evidence of the benefits of functionality. Nevertheless, there needs to be more literature on its effect on cognitive function. AD is a public health emergency that needs to be promptly addressed. This trial will finally determine if an OT-based intervention can decrease cognitive decline and whether it should be included in the standard of care for AD.