Reducing the Effects of Aging on Cognition With Therapeutic Intervention of an Oral Nutrient (REACTION): A Pilot Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to assess the feasibility (e.g., recruitment rate, adherence rate and retention rate) of a clinical trial using virtual assessments to investigate the effect of a 6-month administration of a specific multi-nutrient oral supplement on cognitive aging. The study will also test whether a 6-month daily intake of a specific multinutrient can delay or reverse the effects of normal cognitive aging on other cognition domains as well as quality of life as measured by virtual assessments.

Detailed Description
-----------------
Participants with cognitive aging who meet the eligibility criteria are provided study information and scheduled for a screening visit via virtual encounter. At the screening visit, participants meeting criteria are enrolled, and a baseline visit is scheduled (same day, or separately.) The participants are then randomized to either the test product (specific multi-nutrient) or placebo. Study parameters will be assessed at baseline, and 6 months via a virtual online platform. Patients will be contacted monthly via telephone to promote compliance and monitor progress. An optional sample of blood may be provided by the participant if willing to participated in this optional sub-study.

Official Title
-----------------
REACTION Trial: Medical Nutrition in Cognitive Aging, a Double-blind Controlled 6-month Study

Conditions
-----------------
Cognitive Decline

Intervention / Treatment
-----------------
* Drug: Souvenaid
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English or Spanish speaking participants considered to have age-related cognitive decline based on the following criteria: A) RBANS (Verbal Memory Retention) A score ≥70% on list learning retention AND ≥80% on story memory retention and B) Subjective Cognitive Decline (SCD) 9-item brief screening tool score within the 25th percentile (SCD =1) and 75th percentile (SCD = 6) and C) MoCA ≥24 Age 55-89 Written informed consent provided by participant Exclusion Criteria: Enrollment in any other clinical trial within 30 days prior to participation Major Neurocognitive Disorder (Dementia) according to the Diagnostic and Statistical Manual of Mental Disorders 5th Edition and/or NIAA Criteria Use of any AD medication (e.g., cholinesterase inhibitors, NMDA antagonists), or OTC supplements or cognitive/memory enhancers Use of omega-3 fatty acids in the 30 days prior to participation Intake of Vitamins B6 and B12, folate, Vitamins C and E > 300% RDI in the 24 days prior to participation Concurrent major medical or neurological illness Prior clinical history of stroke History of substance abuse (e.g., alcohol, drugs) Untreated Major Depressive Disorder that has not been in remission for at least 6 months prior to participation

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 89 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Participants in the treatment group will receive 125 mL of Souvenaid taken by mouth, once daily, for 6 consecutive months. | Drug: Souvenaid<br>* Souvenaid is an oral beverage that contains a vitamin mixture (Vitamin A, B1, B2, B3, B5, D) plus three main active ingredients: omega-3 fatty acids, uridine monophosphate, and choline.<br>|
| Placebo Comparator: Placebo Group<br>Participants in the treatment group will receive 125 mL of iso-caloric placebo taken by mouth, once daily, for 6 consecutive months. | Other: Placebo<br>* The Placebo used in this study is an oral beverage vitamin mixture containing Vitamins A, B1, B2, B3 and B5.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful recruitment rate | 50% or more of those who fulfill the criteria and are invited to participate | Baseline | 
| Successful recruitment time | <110% of planned time | Baseline | 
| Successful adherence to the intervention | 80% or more of the test product is consumed | 6 months | 
| Successful Retention rate | Less than 30% of the participants drop-out; Tracking the percentage of participants in the Per-Protocol population (i.e., no protocol deviation) less than 30% of the participants drop-out Tracking the percentage of participants in the Per-Protocol population (i.e., no protocol deviation) | 6 months | 
| Overall feasibility of this study will be assessed | Will take into account all feasibility parameters | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rey Auditory Verbal Learning Task (RAVLT) or WHO/UCLA Auditory Verbal Learning Task (AVLT) | The test takes 10-15 minutes plus a 30-minute delay during which time other measures can be done. | Baseline, 6 months | 
| Digit Span (WAIS-IV) | measures attention and working memory using exercises that require participants to recite a A series of progressively longer sequence of numbers in forwards, backwards and sequencing order. | Baseline, 6 months | 
| The Oral Trail Making Test B | (TMT-B) assesses working memory and cognitive flexibility. Participants are asked to verbally alternate between letters and numbers in sequential order as quickly as possible. | Baseline, 6 months | 
| Matrix reasoning from the Test My Brain (TMB) research battery | The task provides a measure of fluid intelligence and non-verbal reasoning. It is based on a well-validated and widely used matrix reasoning tasks but adapted for virtual administration. | Baseline, 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Memory, Cognitive Aging