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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
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Volunteers
Inclusion criteria
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
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
67 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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