Soininen 2021

Study ID(s) and Acronym(s)
LipiDiDiet
Current Status of Trial
Completed
Study Aim
Treatment MCI
Study Design
RCT
Blinding
Double-blind
Intervention type
Pharmacological
Intervention
Souvenaid (Fortasyn Connect) // Placebo
Dosage and Duration
125 mL once-a-day drink) or an isocaloric, same tasting, placebo control drink
Absolute Number of Participants
311
Health Status/Diagnosis
Mild Cognitive Impairment (MCI) // Prodromal AD
Primary outcomes
Cognition
Key Points
"of the 382 assessed for eligibility, 311 were randomized, of those 162 participants completed the 36-month study, including 81 with 36-month data eligible for efficacy analysis. Over 36 months, significant reductions in decline were observed for the NTB 5-item composite (−60%; between-group difference 0.212 [95% confidence interval: 0.044 to 0.380]; P = 0.014), Clinical Dementia Rating-Sum of Boxes (−45%; P = 0.014), memory (−76%; P = 0.008), and brain atrophy measures; small to medium Cohen's d effect size (0.25–0.31) similar to established clinically relevant AD treatment." Soininen 2021