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

• ClinicalTrials.gov Identifier: NCT04147624
• Recruitment Status: Completed
• First Posted: November 1, 2019
• Last Update Posted: January 25, 2023
• Sponsor: University of Miami
• Collaborator: American Academy of Neurology
• Information provided by (Responsible Party): Christian Camargo, University of Miami

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cognitive Decline	Drug: Souvenaid; Other: Placebo	Phase 2

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 (Clinical Trial)
• Actual Enrollment: 67 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Prevention
• Official Title: REACTION Trial: Medical Nutrition in Cognitive Aging, a Double-blind Controlled 6-month Study
• Actual Study Start Date: June 4, 2021
• Actual Primary Completion Date: December 2, 2022
• Actual Study Completion Date: December 2, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment Group; Participants in the treatment group will receive 125 mL of Souvenaid taken by mouth, once daily, for 6 consecutive months.	Drug: Souvenaid; 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.
Placebo Comparator: Placebo Group; Participants in the treatment group will receive 125 mL of iso-caloric placebo taken by mouth, once daily, for 6 consecutive months.	Other: Placebo; The Placebo used in this study is an oral beverage vitamin mixture containing Vitamins A, B1, B2, B3 and B5.

Outcome Measures

Primary Outcome Measures :

1. Successful recruitment rate [ Time Frame: Baseline ]
   50% or more of those who fulfill the criteria and are invited to participate
2. Successful recruitment time [ Time Frame: Baseline ]
   <110% of planned time
3. Successful adherence to the intervention [ Time Frame: 6 months ]
   80% or more of the test product is consumed
4. 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)

5. Overall feasibility of this study will be assessed [ Time Frame: 6 months ]
   Will take into account all feasibility parameters

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 55 Years to 89 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Florida

University of Miami

Miami, Florida, United States, 33136

Sponsors and Collaborators

University of Miami

American Academy of Neurology

Investigators

• Principal Investigator: Christian Camargo, MD; University of Miami

More Information

• Responsible Party: Christian Camargo, Assistant Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT04147624
• Other Study ID Numbers: 20190750
• First Posted: November 1, 2019
• Last Update Posted: January 25, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Christian Camargo, University of Miami:

Memory; Cognitive Aging

Additional relevant MeSH terms:

Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders