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

Cognitive Decline Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04147624
• Other study ID #: 20190750
• Status: Completed
• Phase: Phase 2
• Start date: June 4, 2021
• Est. completion date: December 2, 2022

Study information

• Verified date: January 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 2, 2022
• Est. primary completion date: December 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction

Intervention

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.

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

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	American Academy of Neurology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Successful recruitment rate	50% or more of those who fulfill the criteria and are invited to participate	Baseline
Primary	Successful recruitment time	<110% of planned time	Baseline
Primary	Successful adherence to the intervention	80% or more of the test product is consumed	6 months
Primary	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
Primary	Overall feasibility of this study will be assessed	Will take into account all feasibility parameters	6 months
Secondary	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.	Baseline, 6 months
Secondary	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.	Baseline, 6 months
Secondary	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.	Baseline, 6 months
Secondary	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.	Baseline, 6 months