REACTION: Reducing the effects of aging on cognition with therapeutic intervention of an oral nutrient — A pilot interventional study for age‐related cognitive decline

Abstract

AbstractBackgroundAge‐related cognitive decline (ARCD) refers to the cognitive changes that can occur in individuals as a consequence of aging, distinct from cognitive changes due to a primary neurodegenerative process (e.g., Alzheimer’s Disease), cerebral ischemia (e.g., vascular dementia), or other pathology. However, there is sparse research into direct interventions for ARCD. Recent research suggests that the underlying mechanism behind ARCD is a loss of synaptic plasticity, which is essential for learning, memory, and the formation of memory engrams, in part through its effects on dendritic spine morphology. Therefore, therapies aimed at rescuing dendritic spine density and increasing synaptic plasticity may be viable strategies for decreasing the effects of ARCD. Souvenaid contains Fortasyn Connect, a specific combination of nutrients designed to enhance synapse formation by providing precursors and cofactors for phospholipid synthesis. In prodromal Alzheimer’s disease, Fortasyn Connect showed beneficial effects on memory, cognition, and brain atrophy [1]. In addition, the data from this study suggest a stronger effect would be expected in participants at earlier stages of prodromal AD. Souvenaid has not yet been tested in individuals with ARCD.MethodTowards this end, we present the design of a 6‐month single‐center pilot clinical trial that aims to perform all assessments via a telemedicine platform. The study design specifically factors in local COVID‐19 restrictions. We plan to recruit 60 participants aged 55‐89 with age‐related cognitive decline, who will be 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.ResultResults of REACTION will provide insight into the feasibility of a virtual study with Souvenaid in ARCD.ConclusionWith the rapidly growing prevalence of ARCD and no pharmacological interventions currently available, nutritional interventions may potentially play an important role to reduce or delay the effects of ARCD.