Cognitive Vitality Pilot Study

NCT07208279 | Recruiting

• 1 other identifier: STUDY00022585
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Healthy Aging; Cognition; Memory; Brain

Outcome Measures

Primary Outcomes (8)

• Digit Span Forward

  Digit Span Forward measures short-term memory (5 min.) Score: Min = 2, Max = 8 \*Higher score means better outcome

  From enrollment to the end of treatment at 45 days.

• 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

  From enrollment to the end of treatment at 45 days.

• Digit Span Backward

  Digit Span Backward measures working memory (5 min.). Score: Min = 2, Max = 8 \*Higher score means better outcome

  From enrollment to the end of treatment at 45 days.

• 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

  From enrollment to the end of treatment at 45 days.

• RAVLT Recall

  Rey Auditory Verbal Learning Test (RAVLT) Recall measures long-term memory (5 min.). Score: Min = 0, Max = 15 \*Higher score means better outcome

  From enrollment to the end of treatment at 45 days.

• Brain Fog Questionnaire

  Brain Fog Questionnaire allows entry of self-reported cognitive difficulties (5 min.). Score: Min = 0, Max = 10 \*Lower score means better outcome

  From enrollment to the end of treatment at 45 days.

• PHQ-9

  The Patient Health Questionnaire (PHQ-9) records depressive symptoms (5 min.). Score: Min = 0, Max = 27 \*Lower score means better outcome

  From enrollment to the end of treatment at 45 days.

• GAD-7

  Generalized Anxiety Disorder 7-item Questionnaire (GAD-7) quantifies anxiety (5 min.). Score: Min = 0, Max = 21 \*Lower score means better outcome

  From enrollment to the end of treatment at 45 days.

Study Arms (2)

Axolt Brain Supplement

EXPERIMENTAL

The active intervention group will be asked to consume 1 packet of Axolt dissolved in about 16 oz of water once a day for 45 days.

Dietary Supplement: Axolt Brain Supplement

Bolero - Flavored Drink Placebo

PLACEBO COMPARATOR

The 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.

Dietary Supplement: Bolero - Flavored Drink Placebo

Interventions

Axolt Brain Supplement DIETARY_SUPPLEMENT

https://axoltbrain.com/ Axolt is a brain health supplement. It includes native ingredients, formulated to help the brain perform at its best.

Axolt Brain Supplement

Bolero - Flavored Drink Placebo DIETARY_SUPPLEMENT

The 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.

Bolero - Flavored Drink Placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arizona State University: lead

Study Sites (1)

Community

West Palm Beach, Florida, 33401, United States

RECRUITING

Study Officials

• Judith Klein-Seetharaman, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judith Klein-Seetharaman, PhD

CONTACT

646-830-2622; jkleinse@asu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Simple random convenience sampling procedures will be used to divide the sample (n = 16) into a control group and an active group (n = 8, respectively). The RAND function in Microsoft Excel will be used as a cost-effective tool to generate a random sample and numerical identification numbers will be assigned to each participant to protect personal information. The active intervention group will be asked to consume 1 packet of Axolt dissolved in about 16 oz of water once a day for 45 days. The 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.

Study Record Dates

• First Submitted: September 27, 2025
• First Posted: October 6, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 11, 2026
• Study Completion (Estimated): August 11, 2026
• Last Updated: October 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be made available after all data have been collected, entered into the REDCap database, data cleaning procedures have been completed, and the primary articles have been published. Data will be available on or before 1/1/2028 and will remain available for a minimum of 3 years.
• Access Criteria: The Arizona State University Research Data Repository can be accessed freely by investigators. This data repository has supporting information about the protocol and contact information for the investigative team.

Locations

US (1)