Cognitive Vitality Pilot Study

Not Applicable

Recruiting

• Conditions: Aging; Healthy Aging; Cognition; Memory; Brain

• Registration Number: NCT07208279
• Lead Sponsor: Arizona State University

Brief Summary

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.

Detailed Description

The primary aim of this randomized, single-site pilot study is to evaluate the effects of the oral liquid dietary supplement Axolt (https://axoltbrain.com) on cognitive function in adults aged 55 and older without cognitive impairment, compared to a control group taking a commercially available, hydration powdered drink flavoring, Bolero (https://bolerousa.net) daily for 45 days. The secondary aim is to assess changes in mood and psychological well-being with supplement intake. The study will use validated, low-risk cognitive measures at baseline and at the end of the study to measure change over time. 20 individuals age 55 years and older will be recruited. Sample size for enrollment: (n =8) for the active group and (n=8) in the control group (16 total), accounting for an anticipated 20% drop out rate.

Study Timeline

• Study Start: 2025-09-01
• Study First Submitted: 2025-09-27
• Study First Submitted QC: 2025-09-27
• Status Verified: 2025-10
• Study First Posted: 2025-10-06
• Last Update Submitted: 2025-10-27
• Last Update Posted: 2025-10-28
• Primary Completion: 2026-08-11
• Study Completion: 2026-08-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Adults aged 55 years and older
• Live independently,
• Self-report as healthy
• Adequate vision
• Fluent in English
• No history of mild cognitive impairment
• Currently not taking dietary supplements with the same active ingredients in Axolt or naturally flavored water
• A Montreal Cognitive Assessment [12] (MOCA) score ≥ 24
• Able to provide written informed consent, and medical clearance to participate.

Exclusion Criteria

• 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
• Parkinson's disease
• History of severe head trauma
• Uncontrolled hypertension
• On psychoactive medications
• Substance abuse
• Unwilling or unable to discontinue current dietary supplements with similar ingredients
• Planned surgery during the study period
• Medications known to interact with active ingredients with Axolt
• Minors and prisoners will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
RAVLT Recall	From enrollment to the end of treatment at 45 days.	Rey Auditory Verbal Learning Test (RAVLT) Recall measures long-term memory (5 min.). Score: Min = 0, Max = 15 \*Higher score means better outcome
Brain Fog Questionnaire	From enrollment to the end of treatment at 45 days.	Brain Fog Questionnaire allows entry of self-reported cognitive difficulties (5 min.). Score: Min = 0, Max = 10 \*Lower score means better outcome
PHQ-9	From enrollment to the end of treatment at 45 days.	The Patient Health Questionnaire (PHQ-9) records depressive symptoms (5 min.). Score: Min = 0, Max = 27 \*Lower score means better outcome
GAD-7	From enrollment to the end of treatment at 45 days.	Generalized Anxiety Disorder 7-item Questionnaire (GAD-7) quantifies anxiety (5 min.). Score: Min = 0, Max = 21 \*Lower score means better outcome
Digit Span Forward	From enrollment to the end of treatment at 45 days.	Digit Span Forward measures short-term memory (5 min.) Score: Min = 2, Max = 8 \*Higher score means better outcome
RAVLT Learning	From enrollment to the end of treatment at 45 days.	Rey Auditory Verbal Learning Test (RAVLT) Learning assesses short-term memory (10 min).; Score: Min = 0, Max = 105 \*Higher score means better outcome
Digit Span Backward	From enrollment to the end of treatment at 45 days.	Digit Span Backward measures working memory (5 min.). Score: Min = 2, Max = 8 \*Higher score means better outcome
Symbol Digit Modalities Test (SDMT)	From enrollment to the end of treatment at 45 days.	Symbol Digit Modalities Test (SDMT) measures perceptual speed (5 min.). Score: Min = 0, Max = 120 \*Higher score means better outcome

Trial Locations

Locations (1)

Community; 🇺🇸 West Palm Beach, Florida, United States