DECREASE: Decrease Cognitive Decline in Alzheimer’s Disease Through Occupational Therapy: A Randomized Controlled Phase III Trial Protocol

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.