Cognitive Vitality Pilot Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55+
SponsorArizona State University
About this trial
This study's purpose is to evaluate the effects of a dietary supplement on cognitive function and psychological well-being in community-dwelling older adults aged 55+. The study involves taking a commercially available dietary supplement daily for 45 days. A 45-minute assessment will be conducted at the beginning and again at the end of the study.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults aged 55 years and older
Live independently,
Self-report as healthy
Adequate vision
Disqualifiers
Previous participation in a cognitive dietary supplement study in the last 12 months
A score of < 24 on the Montreal Cognitive Assessment (MoCA) as a potential risk for obtaining informed consent
History of seizures
Epilepsy
Trial design
Design model
Parallel
Treatments tested in this trial
Axolt Brain Supplement
Dietary supplementhttps://axoltbrain.com/ Axolt is a brain health supplement. It includes native ingredients, formulated to help the brain perform at its best.
Bolero - Flavored Drink Placebo
Dietary supplementThe control group will be asked to consume 1 packet of Bolero flavored water mix hydration enhancement also in about 16 oz of water once a day for 45 days.
Treatment groups
16 Participants
are divided into 2 treatment groupsGroup A: Axolt Brain SupplementExperimental treatment 1 intervention
Group B: Bolero - Flavored Drink PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Digit Span Forward
Digit Span Forward measures short-term memory (5 min.) Score: Min = 2, Max = 8 \*Higher score means better outcome
Time frame
From enrollment to the end of treatment at 45 days.2
RAVLT Learning
Rey Auditory Verbal Learning Test (RAVLT) Learning assesses short-term memory (10 min). Score: Min = 0, Max = 105 \*Higher score means better outcome
Time frame
From enrollment to the end of treatment at 45 days.3
Digit Span Backward
Digit Span Backward measures working memory (5 min.). Score: Min = 2, Max = 8 \*Higher score means better outcome
Time frame
From enrollment to the end of treatment at 45 days.4
Symbol Digit Modalities Test (SDMT)
Symbol Digit Modalities Test (SDMT) measures perceptual speed (5 min.). Score: Min = 0, Max = 120 \*Higher score means better outcome
Time frame
From enrollment to the end of treatment at 45 days.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov