Reducing the Effects of Aging on Cognition With Therapeutic Intervention of an Oral Nutrient (REACTION): A Pilot Trial
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment Group Participants in the treatment group will receive 125 mL of Souvenaid taken by mouth, once daily, for 6 consecutive months. |
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.
|
| Placebo Comparator: Placebo Group Participants in the treatment group will receive 125 mL of iso-caloric placebo taken by mouth, once daily, for 6 consecutive months. |
Other: Placebo
The Placebo used in this study is an oral beverage vitamin mixture containing Vitamins A, B1, B2, B3 and B5.
|
Outcome Measures
Primary Outcome Measures
- Change in normal cognitive aging using the Rey Auditory Verbal Learning Task (RAVLT) or WHO/UCLA Auditory Verbal Learning Task (AVLT) [Baseline, 6 months]
This test measures verbal learning, delayed memory and recognition. It takes 10-15 minutes to administer plus a 30-minute delay during which other measures can be administered. Normalized data exist for cognitively intact individuals up to age 89.
- Change in normal cognitive aging using the Digit Span (WAIS-IV) [Baseline, 6 months]
The Digit Span subtest of the WAIS-IV it measures attention and working memory through a series of exercises that require participants to recite a series of progressively longer sequence of numbers. In the first exercise the numbers must be repeated in the same order as provided by the examiner, in the second exercise the numbers are to be repeated in reverse order and in the third exercise the numbers must be repeated in sequential order from smallest to largest.
- Change in normal cognitive aging using the Oral Trail Making Test (TMT) [Baseline, 6 months]
The oral TMT-B is a mental set shifting an working memory task. Participants are asked to verbally alternate between letters and numbers in sequential order (i.e. A-1-B-2-C-3 and so on until they reach 13) as quickly as they can.
- Change in normal cognitive aging using the - Matrix reasoning from the Test My Brain (TMB) research battery. [Baseline, 6 months]
This 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.
Secondary Outcome Measures
- Change in normal cognitive aging using the - Visual Paired Associated from the TMB research battery. [Baseline, 6 months]
This is a measure of visual episodic memory and takes approximately 6 minutes to complete. Participants are asked to learn and memorize 25 pairs of images. Following a distractor task, individuals are to choose corresponding pairs from a set of target and foil stimuli.
- Change in normal cognitive aging using the - Multilingual Naming Test (MINT) from the National Alzheimer's Coordinating Center's (NACC) neuropsychological battery. [Baseline, 6 months]
The MINT is a research measure intended to assess word retrieval deficits. It requires participants to name a series of individually presented line drawings that range from highly common (e.g. butterfly) to more obscure (e.g., axle) objects.
- Change in normal cognitive aging using the - Verbal Fluency Tests (FAS, PTM-MAE) [Baseline, 6 months]
These tests assess verbal fluency in participants. The FAS and PTM evaluate phonemic fluency in English and Spanish respectively. Individuals are asked to produce as many words as they can that start with each of three letters (i.e. F, A, and S in English; P, T, and M in Spanish) in one minute. Semantic fluency will be assessed by asking participants to name as many animals as possible in one minute.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Participants considered to have age-related cognitive decline based on the following criteria:
- 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)
- Participants will additionally be expected to score in the normal range of MoCA, defined in this study as greater than 24/30.
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Age 55-89
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Written informed consent provided by participant
Exclusion Criteria:
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Enrollment in any other clinical trial within 30 days
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Major Neurocognitive Disorder ("Dementia") according to the Diagnostic and Statistical Manual of Mental Disorders 5th Edition.
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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.
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Concurrent major medical or neurological illness
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Prior clinical history of stroke or cancer
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History of substance abuse (e.g., alcohol, drugs)
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Untreated Major Depressive Disorder that has not been in remission for at least 6 months prior to participation
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Treatment with any AD medication or OTC supplements or 'cognitive/memory' enhancers
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Miami | Miami | Florida | United States | 33136 |
Sponsors and Collaborators
- University of Miami
- American Academy of Neurology
Investigators
- Principal Investigator: Christian Camargo, MD, University of Miami
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20190750