ABSTRACT NUMBER: ESOC2026OT154 PROTECTING THE BRAIN FROM POST-STROKE COGNITIVE IMPAIRMENT AND DEMENTIA WITH MULTIMODAL EXERCISE TRAINING: THE PROTECT TRIAL

Abstract Background and aims Fifty two percent of stroke patients experience persistent cognitive impairment within 6 months post-stroke and 20% receive a diagnosis of dementia within the first 5 years. Targeted interventions that stimulate neuroprotection during the early phases of recovery could lower the high incidence of post-stroke cognitive impairment and dementia. Multimodal exercise, combining aerobic and resistance training, has moderate effects on cognition post-stroke, but the potential long-term effects of multimodal exercise implemented in the subacute phase of recovery on cognitive decline and dementia risk have not been evaluated. Methods To compare the effects of three months of multimodal training and an adapted community-based stroke exercise control intervention on cognition and on imaging and blood biomarkers associated with accelerated cognitive decline and dementia risk in patients with subacute stroke (<6 months). Results This is a Phase 3 single-blinded multisite adaptive clinical trial with a two-arm parallel sequential design. Participants will be randomized into the two training arms using a sequence with permuted blocks of varying sizes. We will enroll a total of 126 participants to achieve a power of 85%, with a type I error of 5% and a drop-out rate of 25%. Conclusions The primary outcome is cognition assessed with the Alzheimer’s Disease Assessment Scale-Cognitive-Plus (ADAS-Cog-Plus). Secondary outcomes include imaging and blood biomarkers associated with accelerated cognitive decline and dementia risk. Functional mobility, body composition, quality of life and health care resource utilization will also be assessed. Outcomes will be assessed at baseline, after the interventions and at 6- and 12-month follow-up. Conflict of interest