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

NCT04147624 | Completed Phase 2

• 1 other identifier: 20190750
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Decline

Keywords

Memory; Cognitive Aging

Outcome Measures

Primary Outcomes (5)

• Successful recruitment rate

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

  Baseline

• Successful recruitment time

  \<110% of planned time

  Baseline

• Successful adherence to the intervention

  80% or more of the test product is consumed

  6 months

• 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)

  6 months

• Overall feasibility of this study will be assessed

  Will take into account all feasibility parameters

  6 months

Secondary Outcomes (4)

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

  Baseline, 6 months

• Digit Span (WAIS-IV)

  Baseline, 6 months

• The Oral Trail Making Test B

  Baseline, 6 months

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

  Baseline, 6 months

Study Arms (2)

Treatment Group

EXPERIMENTAL

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

Drug: Souvenaid

Placebo Group

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

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.

Treatment Group

Placebo OTHER

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

Placebo Group

Eligibility Criteria

• Age: 55 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead
• American Academy of Neurology: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Souvenaid

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Christian Camargo, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 1, 2019
• Study Start: June 4, 2021
• Primary Completion: December 2, 2022
• Study Completion: December 2, 2022
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)