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

NCT ID: NCT04147624

Last Updated: 2023-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-04
• Study Completion Date: 2022-12-02

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.

Conditions

Cognitive Decline

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Treatment Group

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

Group Type: EXPERIMENTAL

Souvenaid

Intervention Type: 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 Group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Academy of Neurology

OTHER

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Christian Camargo

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christian Camargo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Other Identifiers

20190750

Identifier Type: -

Identifier Source: org_study_id