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

• Status: Recruiting
• Trial end date: 2022-01-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami
• Collaborator: American Academy of Neurology

Criteria

Inclusion Criteria:

1. Participants considered to have age-related cognitive decline based on the following criteria:

A) A score of >85th percentile on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).

and B) Subjective Cognitive Decline (SCD) 9-item brief screening tool score within the 25th percentile (SCD =1) and 75th percentile (SCD = 6)

C) Participants will additionally be expected to score in the normal range of MoCA, defined in this study as greater than 24/30.

2. Age 55-89

3. Written informed consent provided by participant

Exclusion Criteria:

1. Enrollment in any other clinical trial within 30 days

2. Major Neurocognitive Disorder ("Dementia") according to the Diagnostic and Statistical Manual of Mental Disorders 5th Edition.

3. Use of the following supplements in the 24 days prior to participation: Vitamins B6 and B12, folate, Vitamins C and E. And use of omega-3 fatty acids 30 days prior to participation.

4. Concurrent major medical or neurological illness

5. Prior clinical history of stroke or cancer

6. History of substance abuse (e.g., alcohol, drugs)

7. Untreated Major Depressive Disorder that has not been in remission for at least 6 months prior to participation

8. Treatment with any AD medication or OTC supplements or 'cognitive/memory' enhancers