36‐month LipiDiDiet multinutrient clinical trial in prodromal Alzheimer's disease. Issue 1 (13th September 2020)

• Record Type: Journal Article
• Authors: Soininen, Hilkka; Solomon, Alina; Visser, Pieter Jelle; Hendrix, Suzanne B; Blennow, Kaj; Kivipelto, Miia; Hartmann, Tobias
• Is Part Of: Alzheimer's & dementia. Volume 17:Issue 1(2021)
• Page Start: 29
• Page End: 40
• Publication Date: 2020-09-13
• Subjects: Alzheimer's disease -- atrophy -- cognition -- dietary intervention -- function -- hippocampus -- mild cognitive impairment -- nutrition -- omega 3 -- prodromal -- randomized controlled clinical trial -- therapy; Alzheimer's disease -- Periodicals; Alzheimer Disease -- Periodicals; Dementia -- Periodicals; Démence; Maladie d'Alzheimer; Périodique électronique (Descripteur de forme); Ressource Internet (Descripteur de forme); 616.83
• DOI: 10.1002/alz.12172
• Languages: English
• ISSNs: 1552-5260

Abstract

Abstract: Introduction: The LipiDiDiet trial investigates the effects of the specific multinutrient combination Fortasyn Connect on cognition and related measures in prodromal Alzheimer's disease (AD). Based on previous results we hypothesized that benefits increase with long‐term intervention. Methods: 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. Main outcome was change in cognition (Neuropsychological Test Battery [NTB] 5‐item composite). Analyses were by modified intention‐to‐treat, excluding (ie, censoring) data collected after the start of open‐label active product and/or AD medication. Results: 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. Discussion: This multinutrient intervention slowed decline on clinical and other measures related to cognition, function, brain atrophy, and disease progression. These results indicate that intervention benefits increased with long‐term use.