Mild Cognitive Impairment with a High Risk of Progression to Alzheimer’s Disease Dementia (MCI-HR-AD): Effect of Souvenaid(®) Treatment on Cognition and (18)F-FDG PET Scans

BACKGROUND: Previous studies have shown that Souvenaid (medical food) can have benefits on memory, cognition, and function in early Alzheimer’s disease (AD) and mild cognitive impairment (MCI). OBJECTIVE: Demonstrate that Souvenaid could improve or maintain cognition and has an effect on neurodegeneration biomarkers. METHODS: This cohort study was carried out from June 2015 through December 2016 in the Neurology Department, Infanta Cristina Hospital, Madrid, Spain. MCI-HR-AD were recruited using Petersen criteria, neuropsychology (NPS), and (18)F-FDG PET scans to confirm the high risk of progression to dementia with one year of follow-up. Age, sex, vascular risk factors (VRF), and NPS values (Barcelona brief version) were analyzed. (18)F-FDG PET scans were analyzed as a visual procedure. The study was approved by the Research Committee of ICH. Statistical analysis was made with SPSS 22.0 version. RESULTS: Subjects included 43 MCI patients (58.5% women; mean age 69.78±7.89): 17 receiving Souvenaid(®) treatment (ST), 24 receiving no treatment (WT) and 2 who withdrew. No differences were seen in VRF, only hypercholesterolemia, and were less prevalent in the ST group (p = 0.002). The rate of progression to dementia was 48.8% (no differences between groups, p = 0.654). A second round of (18)F-FDG PET scans showed a significance worsening of glucose metabolism in WT (p = 0.001) versus ST, in which it was low (p = 0.050). For NPS testing, there was a significant worsening in memory performance in the WT group (p = 0.011) and a stabilization in ST (p = 0.083), as well as in executive functions and attention (worsening in WT, p = 0.014). For the Subjective Changing Scale (SCS), caregivers indicated a stabilization/improvement in ST (p = 0.017). CONCLUSION: Souvenaid had a significant effect on several cognitive domains, and on SCS in patients with MCI-HR-AD. Its intervention had an impact on preservation on (18)F-FDG PET scans.