The Memory and Cognitive Performance Study (NCT04025255) | Clinical Trial Compass
CompletedNot Applicable
The Memory and Cognitive Performance Study
United States74 participantsStarted 2019-10-01
Plain-language summary
The primary purpose of this study is to evaluate the impact of a novel, neuro-protective and neuro-restorative dietary supplement (BrainiĀ®) on standardized memory and cognitive performance parameters. The principal active ingredients in the BrainiĀ® supplement have been commercially-available since at least 2015 or have achieved FDA new dietary ingredient notification (NDIN) in 2018, with no adverse events reported to the FDA.
A 28-day randomized, double-blinded, placebo-controlled dietary supplement study will be conducted with a cohort of younger and a cohort of colder adults to achieve the purpose of this study. The research team hypothesizes that BrainiĀ® will improve standardized performance scores measured by CNS Vital Signs standard memory and cognitive performance assays more effectively than placebo.
Who can participate
Age range18 Years ā 80 Years
SexALL
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Inclusion criteria
ā. 18-30 or 55-80 years of age
ā. Agree to continue with current diet and refrain from taking any new nutritional or herbal supplements
ā. Willing to participate in the trial for 30-35 days, including taking a placebo
ā. Able to understand and write English
Exclusion criteria
ā. Clinically diagnosed with Alzheimer's disease, stroke, Parkinson's disease, or dementia
ā. Taking prescription drugs to support memory/prevent cognitive decline in the past 180 days or to treat other diseases referenced below in criterion number.
ā. Taking dietary supplements that include wild blueberry extract, Neurxcel, or silk portein peptide in the past 90 days
ā. Active fibromyalgia, multiple sclerosis, seizures/epilepsy or other known diseases that affect memory or cognition
ā. Taking an medicines that are stimulants including Adderall XR (amphetamine), Concerta (methylphenidate), Dexedrine (amphetamine), Evekeo (amphetamine), Focalin XR (methylphenidate), Quillivant XR (methylphenidate), Ritalin (methylphenidate), Strattera (atomoxetine hydrochloride), or Vyvanse (lisdexamfetamine dimesylate).