Clinical trial NCT04147624: Reducing the Effects of Aging on Cognition With Therapeutic Intervention of an Oral Nutrient (REACTION): A Pilot Trial
Official title: REACTION Trial: Medical Nutrition in Cognitive Aging, a Double-blind Controlled 6-month Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cognitive Decline
Keywords: Memory
Cognitive Aging
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: American Academy of Neurology
First posted: 2019-11-01
Enrollment: 67
Sex: ALL
Minimum age (years): 55
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

1. 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
2. Age 55-89
3. Written informed consent provided by participant

Exclusion Criteria:

1. Enrollment in any other clinical trial within 30 days prior to participation
2. Major Neurocognitive Disorder ("Dementia") according to the Diagnostic and Statistical Manual of Mental Disorders 5th Edition and/or NIAA Criteria
3. Use of any AD medication (e.g., cholinesterase inhibitors, NMDA antagonists), or OTC supplements or cognitive/memory enhancers
4. Use of omega-3 fatty acids in the 30 days prior to participation
5. Intake of Vitamins B6 and B12, folate, Vitamins C and E \> 300% RDI in the 24 days prior to participation
6. Concurrent major medical or neurological illness
7. Prior clinical history of stroke
8. History of substance abuse (e.g., alcohol, drugs)
9. Untreated Major Depressive Disorder that has not been in remission for at least 6 months prior to participation

Primary outcomes:
measure: Successful recruitment rate
timeFrame: Baseline
measure: Successful recruitment time
timeFrame: Baseline
measure: Successful adherence to the intervention
timeFrame: 6 months
measure: Successful Retention rate
timeFrame: 6 months
measure: Overall feasibility of this study will be assessed
timeFrame: 6 months
Secondary outcomes:
measure: Rey Auditory Verbal Learning Task (RAVLT) or WHO/UCLA Auditory Verbal Learning Task (AVLT)
timeFrame: Baseline, 6 months
measure: Digit Span (WAIS-IV)
timeFrame: Baseline, 6 months
measure: The Oral Trail Making Test B
timeFrame: Baseline, 6 months
measure: Matrix reasoning from the Test My Brain (TMB) research battery
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Christian Camargo, MD
role: PRINCIPAL_INVESTIGATOR
References: