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

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University of Miami

Status and phase

Completed
Phase 2

Conditions

Cognitive Decline

Treatments

Other: Placebo
Drug: Souvenaid

Study type

Interventional

Funder types

Other

Identifiers

NCT04147624
20190750

Details and patient eligibility

About

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.

Full 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.

Enrollment

67 patients

Sex

All

Ages

55 to 89 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

67 participants in 2 patient groups, including a placebo group

Treatment Group
Experimental group
Description:
Participants in the treatment group will receive 125 mL of Souvenaid taken by mouth, once daily, for 6 consecutive months.
Treatment:
Drug: Souvenaid
Placebo Group
Placebo Comparator group
Description:
Participants in the treatment group will receive 125 mL of iso-caloric placebo taken by mouth, once daily, for 6 consecutive months.
Treatment:
Other: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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