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Completed

NCT Number: NCT04147624

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

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.

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Key information

Conditions

Cognitive Decline Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

55 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Miami

Miami, Florida, 33136, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Souvenaid

Drug

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

Other

The Placebo used in this study is an oral beverage vitamin mixture containing Vitamins A, B1, B2, B3 and B5.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • American Academy of Neurology

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 1, 2019
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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