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Cognitive Vitality Pilot Study

Cognitive Vitality Pilot Study

Recruiting
55 years and older
All
Phase N/A

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Overview

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.

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.

Eligibility

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 details
    Aging
    Healthy Aging
    Cognition
    Memory
    Brain

NCT07208279

Arizona State University

1 November 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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