Reducing the Effects of Aging on Cognition with Therapeutic Intervention of an Oral multi‐Nutrient combination (REACTION): Study Design and Baseline Results

Abstract

AbstractBackgroundAlzheimer’s Disease (AD) is the most common cause of dementia, and the risk of developing AD increases with age. Age‐related cognitive decline (ARCD) refers to the cognitive changes that can occur in individuals because of aging. Research suggests that the underlying mechanism behind ARCD is a loss of synaptic plasticity and altered dendritic spine morphology. Similarly, the cognitive changes in AD are also thought to arise from impaired synaptic plasticity and dendritic spine loss. Souvenaid, contains a specific combination of precursors and cofactors for phospholipid biosynthesis, and has shown beneficial effects on memory, cognition, and brain atrophy in prodromal AD. In addition, data from this previous study imply a stronger effect would be expected in participants at earlier stages of prodromal AD. To test the effect of Souvenaid in ARCD, the REACTION (Reducing the Effects of Aging on Cognition with Therapeutic Intervention of an Oral multi‐Nutrient combination) pilot study was developed.MethodREACTION1 is a 6‐month single‐center randomized, double‐blind placebo‐controlled pilot clinical trial. The study factors in local COVID‐19 restrictions and is conducted fully virtually. Participants will be aged 55‐89 with ARCD, and screened and randomized to the oral multi‐nutrient combination (Souvenaid) or placebo on a 1:1 basis.The main outcome of this trial is feasibility (recruitment rate and time, adherence rate and retention rate). Other outcomes include memory (e.g. Ray Verbal Learning Task), cognition (e.g. Oral Trail Making Test), and quality of life (e.g. Amsterdam IADL Questionnaire) outcome measures.ResultOf 141 inquiries over 7 months, 60 eligible participants were recruited. 54 were successfully screened for randomization. As of 3 Feb 2022, 47 participants have been randomized to placebo or Souvenaid (6 are awaiting randomization, 1 withdrew prior to randomization.) Detailed baseline characteristics of the study population will be presented at the meeting, including descriptive statistics on demographics and the inclusion criteria such as the RBANS, MoCA and SCD 9‐item brief screening tool score.ConclusionWith the rapidly growing prevalence of ARCD and limited pharmacological curative treatment options currently available, nutritional interventions may potentially play an important role to prevent or delay the onset of ARCD.1. Clinicaltrial.gov identifier: NCT04147624