REACTION Trial: Medical Nutrition in Cognitive Aging, a Double-blind Controlled 6-month Study
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Miami
- Enrollment
- 67
- Locations
- 1
- Primary Endpoint
- Successful recruitment rate
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 55 Years to 89 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
Treatment Group
Participants in the treatment group will receive 125 mL of Souvenaid taken by mouth, once daily, for 6 consecutive months.
Intervention: Souvenaid (Drug)
Placebo Group
Participants in the treatment group will receive 125 mL of iso-caloric placebo taken by mouth, once daily, for 6 consecutive months.
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Successful recruitment rate
Time Frame: Baseline
50% or more of those who fulfill the criteria and are invited to participate
Successful Retention rate
Time Frame: 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
Time Frame: 6 months
80% or more of the test product is consumed
Successful recruitment time
Time Frame: Baseline
\<110% of planned time
Overall feasibility of this study will be assessed
Time Frame: 6 months
Will take into account all feasibility parameters
Secondary Outcomes
- Rey Auditory Verbal Learning Task (RAVLT) or WHO/UCLA Auditory Verbal Learning Task (AVLT)(Baseline, 6 months)
- Digit Span (WAIS-IV)(Baseline, 6 months)
- The Oral Trail Making Test B(Baseline, 6 months)
- Matrix reasoning from the Test My Brain (TMB) research battery(Baseline, 6 months)
Investigators
Christian Camargo
Assistant Professor
University of Miami