BACKGROUND: Cognitive frailty (CF) in older adults is a potentially reversible syndrome that may benefit from lifestyle-based multidomain interventions. This study assessed the AGELESS intervention's impact on cognitive, physical, vascular, dietary, and psychosocial outcomes, along with its cost-effectiveness, in a Low-Middle-Income Country (LMIC). METHODS: The AGELESS randomized controlled trial recruited 106 older adults (above 60 years) from Klang Valley, Malaysia, with (pre)-CF (>= 1 Fried's criteria and Clinical Dementia Rating scale 0.5). Participants were randomly assigned to a 24-month multidomain intervention (physical activity, cognitive training, nutritional and psychological counselling, cardiovascular care) or control group (educational module). Primary outcomes, assessed at baseline, 12 and 24 months, included the modified Neuropsychological Tests Battery (mNTB) and physical performance measures. Intervention costs were calculated to determine Incremental Cost-Effectiveness Ratios (ICERs). An intention-to-treat analysis was conducted to account for attrition. RESULTS: The trial occurred during the COVID-19 pandemic. Despite a 50% dropout rate, adherence among remaining participants was over 50% for all intervention components (range 53% to 91%). The intervention led to significant improvements in selected parameters of cognitive function, physical performance, anthropometry, and dietary patterns (for all parameters, p < 0.05 for interaction time*group in repeat-measures ANOVA). The cost per participant was RM 1592.74 (USD 355.05) in the multidomain arm, and RM 488.21 (USD 108.83) in the control arm. The ICER computation indicated the 2-min step test as the most cost-effective measure (ICER RM 149.19 USD33.26). CONCLUSION: The AGELESS trial demonstrates that a multidomain, lifestyle-based intervention can improve cognitive and physical function in older adults with (pre)-CF. This cost-effective approach highlights CF as a modifiable health condition and supports its potential inclusion in health policy to promote healthy aging and reduce health risks in LMICs, where there is a larger prevention potential due to prevalent lifestyle-related risk factors.

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