SUPERA® Cognitive Stimulation Study - effectiveness of a multi-component cognitive stimulation program for cognitively unimpaired older adults: A randomized controlled clinical trial

BACKGROUND: The SUPERA® Cognitive Stimulation program was tested in a randomized, single-blinded, controlled clinical trial to investigate its effectiveness in older adults without cognitive impairment or dementia. METHODS: A total of 207 participants were randomly assigned to three groups: Training Group (TG), Active Control Group (ACG), and Passive Control Group (PCG). The TG (n = 65) received the SUPERA® Cognitive Stimulation program in 72 weekly cognitive stimulation sessions over 18 months; the ACG (n = 63) received health and lifestyle education; and the PCG (n = 79) received no intervention. Participants were assessed at baseline (T0), 6 (T1), 12 (T2), 18 (T3), and 24 (T4) months (six-month follow-up). Main outcomes included a battery of cognitive performance tests. Additional outcomes included psychological symptoms, quality of life, and self-perceived cognitive functioning. Intention-to-treat (ITT) analyses using Linear Mixed Models were conducted. RESULTS: Main outcomes showed significant improvement in Phonemic Verbal Fluency (FAS) in the TG, with evidence of maintenance of effects at the twenty-four-month follow-up. The post-hoc analysis of the composite scores revealed significant time-group interactions favoring the TG for memory, executive function, and global cognition. Specifically, a marked time-group interaction was observed on the FAS in favor of the TG, an effect that was sustained at the six-month follow-up (T4). Furthermore, robust effects were found for subjective cognitive functioning. In this domain, the time-group interaction analysis was consistently favorable for the TG, which reported sustained gains across all follow-up assessments. These findings demonstrate the positive impact of the intervention on objective cognitive performance, and particularly on participants´ self-perceived functioning. CONCLUSIONS: These findings suggest that an 18-month-long multicomponent SUPERA® Cognitive Stimulation program may represent an effective preventive strategy against cognitive decline among healthy older adults. However, further studies are needed to confirm long-term benefits and to explore the mechanisms underlying the reported improvements.