Reducing the Effects of Ageing on Cognition with Therapeutic Intervention of an Oral Multi-Nutrient: The REACTION Pilot Trial Study Design

Abstract

BackgroundClinical benefits have been reported with a specific multinutrient intervention (Souvenaid) in Alzheimer’s disease and mild cognitive impairment due to Alzheimer’s disease. The effects of Souvenaid in age-related cognitive decline are not established.ObjectiveTo assess the feasibility of using virtual assessments to study the effects of a multinutrient on cognitive ageing.DesignThis is a randomized, double-blind, placebo-controlled, parallel group virtual pilot trial performed over 6 months in a single-centre. Participants are randomly allocated (1:1) to receive the specific multinutrient (Souvenaid) or an isocaloric, same tasting, placebo.SettingTrial visits are done virtually using secure online video communication.ParticipantsEnglish or Spanish speaking people aged 55–89 years from all ethnic groups and considered to have age-related cognitive decline are eligible.MeasurementsNeuropyschological tests are done at baseline and after 6 months of intervention. Participants are contacted monthly by telephone to monitor safety, assess motivation and promote compliance. The primary outcome is feasibility determined by assessing recruitment rate, recruitment time, adherence rate and retention rate. A comprehensive set of neuropyschological measures will provide a broad assessment of cognitive function, including verbal memory, processing speed, and attention and executive function. Self-reported questionnaires are used to assess quality of life.ConclusionsThis pilot trial will provide data to guide inform selection of participants and outcome measures in future studies in age-related cognitive decline.