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

Abstract

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.

Souvenaid in the management of mild cognitive impairment: an expert consensus opinion

“…Real-world data and patient experience programs have also reported benefits for Souvenaid in patients with cognitive impairment and mild AD, including increased motivation and social engagement, improved energy levels, physical and mental resilience, and improvements in mood, cognition, and memory associated with a return to functional tasks and hobbies [105–110]. One study showed that Souvenaid was effective on behavioral and functional deficits [105], while another reported improvements in depression, anxiety, and apathy [109].…”

“…One study showed that Souvenaid was effective on behavioral and functional deficits [105], while another reported improvements in depression, anxiety, and apathy [109]. Furthermore, caregivers reported benefits in the Subjective Changing Scale (SCS) in patients with MCI at high risk of progression to AD taking Souvenaid [110]. It is important to note that data from these studies are not as strong as the data from randomized controlled trials.…”

Effects of preventive interventions on neuroimaging biomarkers in subjects at-risk to develop Alzheimer's disease: A systematic review

“…Studies involving CI participants all reported an effect of the nutritional interventions on either brain metabolism, perfusion or function ( Table 5 ). One year of Souvenaid preserved glucose metabolism in MCI, while hypometabolism was observed for the sham intervention (Manzano Palomo et al, 2019 ). Twenty-six weeks of ω-3 supplementation increased CBF in posterior regions for aMCI (Schwarz et al, 2017 ).…”

Efficacy of Souvenaid® Combined with Acetylcholinesterase Inhibitors in the Treatment of Mild Alzheimer’s Disease

“…On the other hand, a cohort study of patients with MCI at risk for progression to AD used 18 F-FDG PET scans as a direct indicator of synaptic function and organization. The results found that scans of patients taking Souvenaid showed less significant worsening of glucose metabolism compared to the significant worsening of those patients who did not take Souvenaid [ 37 ]. In line with findings in preclinical studies, proton magnetic resonance spectroscopy reveals that Souvenaid affects brain phospholipid metabolism in mild AD [ 45 ].…”