Separation studio 4 trial
These results indicate that intervention benefits increased with long-term use.ģ6‐month LipiDiDiet multinutrient clinical trial in prodromal Alzheimer's diseaseĮxperts consensus opinions on dementia prevention suggested that progression from mild cognitive impairment (MCI) to dementia could be reduced by attention to modifiable risk factors related to lifestyle. This multinutrient intervention slowed decline on clinical and other measures related to cognition, function, brain atrophy, and disease progression. Over 36 months, significant reductions in decline were observed for the NTB 5-item composite (−60% between-group difference 0.212 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. 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. Analyses were by modified intention-to-treat, excluding (ie, censoring) data collected after the start of open-label active product and/or AD medication. Main outcome was change in cognition (Neuropsychological Test Battery 5-item composite).
In this randomized, double-blind, placebo-controlled trial, 311 people with prodromal AD were recruited using the International Working Group-1 criteria and assigned to active product (125 mL once-a-day drink) or an isocaloric, same tasting, placebo control drink. Based on previous results we hypothesized that benefits increase with long-term intervention.
The LipiDiDiet trial investigates the effects of the specific multinutrient combination Fortasyn Connect on cognition and related measures in prodromal Alzheimer's disease (AD).