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

Primary Purpose

Cognitive Decline

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Souvenaid

Placebo

About this trial

This is an interventional prevention trial for Cognitive Decline focused on measuring Memory, Cognitive Aging

Eligibility Criteria

55 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment Group

Placebo Group

Arm Description

Participants in the treatment group will receive 125 mL of Souvenaid taken by mouth, once daily, for 6 consecutive months.

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

Outcomes

Primary Outcome Measures

Successful recruitment rate

50% or more of those who fulfill the criteria and are invited to participate

Successful recruitment time

<110% of planned time

Successful adherence to the intervention

80% or more of the test product is consumed

Successful Retention rate

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)

Overall feasibility of this study will be assessed

Will take into account all feasibility parameters

Secondary Outcome Measures

Rey Auditory Verbal Learning Task (RAVLT) or WHO/UCLA Auditory Verbal Learning Task (AVLT)

The test takes 10-15 minutes plus a 30-minute delay during which time other measures can be done.

Digit Span (WAIS-IV)

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

(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

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.

Full Information

NCT ID

NCT04147624

First Posted

October 30, 2019

Last Updated

January 23, 2023

Sponsor

University of Miami

Collaborators

American Academy of Neurology

1. Study Identification

Unique Protocol Identification Number

NCT04147624

Brief Title

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

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

June 4, 2021 (Actual)

Primary Completion Date

December 2, 2022 (Actual)

Study Completion Date

December 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Miami

Collaborators

American Academy of Neurology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cognitive Decline

Keywords

Memory, Cognitive Aging

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

67 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Group

Arm Type

Experimental

Arm Description

Participants in the treatment group will receive 125 mL of Souvenaid taken by mouth, once daily, for 6 consecutive months.

Arm Title

Placebo Group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Souvenaid

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Successful recruitment rate

Description

50% or more of those who fulfill the criteria and are invited to participate

Time Frame

Baseline

Title

Successful recruitment time

Description

<110% of planned time

Time Frame

Baseline

Title

Successful adherence to the intervention

Description

80% or more of the test product is consumed

Time Frame

6 months

Title

Successful Retention rate

Description

Time Frame

6 months

Title

Overall feasibility of this study will be assessed

Description

Will take into account all feasibility parameters

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Rey Auditory Verbal Learning Task (RAVLT) or WHO/UCLA Auditory Verbal Learning Task (AVLT)

Description

The test takes 10-15 minutes plus a 30-minute delay during which time other measures can be done.

Time Frame

Baseline, 6 months

Title

Digit Span (WAIS-IV)

Description

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.

Time Frame

Baseline, 6 months

Title

The Oral Trail Making Test B

Description

(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.

Time Frame

Baseline, 6 months

Title

Matrix reasoning from the Test My Brain (TMB) research battery

Description

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.

Time Frame

Baseline, 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

89 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian Camargo, MD

Organizational Affiliation

University of Miami

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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