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NCT Number: NCT06726616

Physical and Cognitive Aging Study in Older Adults

Hispanic Americans are the fastest growing older adult group in the United States, disproportionally increasing the risk of an Alzheimer's disease and related dementias diagnosis. Efforts to reduce this risk and mitigate the related cognitive/physical declines are critical. The aim of this study is to assess the feasibility of enrolling older adults into an aging trajectory cohort, while generating preliminary data on associations of physical and cognitive aging trajectories. Our secondary objective is to generate preliminary data on the association of standard measures of physical activity and physical function with cognitive status. This study fits within our longitudinal research goal to reduce dementia incidence by understanding the mechanisms that drive the cognitive-physical aging trajectory.

Recruiting

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Key information

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida, College of Medicine-Jacksonville

Jacksonville, Florida, 32206, United States

Location status: Recruiting

Location contact

Sol Colindres Solorzano Research Coordinator

CONTACT

[email protected]

9042449711

Stacey Alvarez-Alvarado

CONTACT

[email protected]

904-244-9937

About this study

Overview: This study aims to assess the feasibility of recruiting and retaining 50 Hispanic American (HA) and 50 non-Hispanic American (non-HA) adults, aged 55-85, into a longitudinal aging cohort. We will evaluate differences in physical activity, physical function, and cognitive performance over time.

Design and Outcomes: Adults will be consented at the beginning of visit 1. Those potentially eligible will complete MoCA, questions about previous and current medical history, and general cognitive function (visit 1). Eligibility will be confirmed at the end of visit 1. Physical fitness, and physical activity behaviors will be assessed during visit 2. Once both visits are completed, the study team will ask about attendance availability in the future. The study team will reach out following one year (or up to 3 months after the one-year mark). The participants will be asked to repeat the same procedures as visits 1 and 2 (1 year follow-up = visits 3 and 4).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hispanic and non-Hispanic adults age 55-85 years, at least 8th grade education, community dwelling.

Additional Inclusion for Hispanic Americans

  • Self-identify as Hispanic American
  • Report Spanish as primary language • No evidence of dementia or mild cognitive impairment based on cognitive screening [i.e., Montreal Cognitive Assessment (MoCA) administered during Visit 1; ≥26 among non-Hispanic White, ≥25 among Hispanics, ≥24 among non-Hispanic Blacks (Milani et al., 2018)]

Exclusion criteria

  • Inability to provide informed consent
  • Artificial joint or severe disability that would make it impossible or contraindicated performing the isokinetic test
  • Sensory loss (vision, hearing) or motor deficits that would preclude participation in the experimental tasks or neuropsychological assessment
  • Previous major strokes or other known significant brain abnormalities or diseases affecting the brain and/or cognition (e.g., Parkinson disease, multiple sclerosis, seizure disorder, brain surgery, moderate TBI, REM Behavior Sleep Disorder, untreated sleep apnea, etc.)
  • Unstable and uncontrolled medical conditions (metastatic cancer, HIV, moderate-severe kidney disease, uncontrolled diabetes, uncontrolled hypertension, severe cardiac disease, etc.). No current cancer diagnosis.
  • Current or past history of major psychiatric disturbance including schizophrenia, or active psychosis, bipolar disorder, current major depressive episode, current alcohol or substance abuse or history thereof within the past six months
  • Use of antipsychotics, sedatives, or other medications with significant anticholinergic properties (due to potential influence on memory)
  • Use of prescribed 'memory enhancing' medications, such as Aricept or Namenda
  • Previous participation in a cognitive or physical activity training study within the last 6 months or current involvement in another study involving cognitive, physical or other intervention at the time of enrollment

Treatment and study plan

Primary outcomes

  1. Rate of recruitment

    Time frame: From recruitment to follow-up (1-year)

    Recruiting > 80% participants (50 Hispanic American and 50 non-Hispanic American adults) for a longitudinal aging study.

Study contacts

Contact information is provided by the study sponsor or research team.

Stacey Alvarez-Alvarado, PhD, MS

CONTACT

[email protected]

904-244-9937

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

PASOS: Physical and Cognitive Aging Study in Older Adults

Acronym: PASOS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 10, 2024
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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