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

Phase 2

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Treatment Group	Souvenaid	Participants in the treatment group will receive 125 mL of Souvenaid taken by mouth, once daily, for 6 consecutive months.
Placebo Group	Placebo	Participants in the treatment group will receive 125 mL of iso-caloric placebo taken by mouth, once daily, for 6 consecutive months.

Primary Outcome Measures

Name	Time	Method
Successful recruitment rate	Baseline	50% or more of those who fulfill the criteria and are invited to participate
Successful Retention rate	6 months	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)
Successful adherence to the intervention	6 months	80% or more of the test product is consumed
Successful recruitment time	Baseline	\<110% of planned time
Overall feasibility of this study will be assessed	6 months	Will take into account all feasibility parameters

Secondary Outcome Measures

Name	Time	Method
Rey Auditory Verbal Learning Task (RAVLT) or WHO/UCLA Auditory Verbal Learning Task (AVLT)	Baseline, 6 months	The test takes 10-15 minutes plus a 30-minute delay during which time other measures can be done.
Digit Span (WAIS-IV)	Baseline, 6 months	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.
The Oral Trail Making Test B	Baseline, 6 months	(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.
Matrix reasoning from the Test My Brain (TMB) research battery	Baseline, 6 months	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.