Recruiting

Observational Study

Sponsor:

University of Florida

Code:

NCT06726616

Conditions

Older Adults (65 Years and Older)

Hispanic Americans

Cognitive Aging

Aging, Healthy

Exercise

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Accepted

Study Details

Brief summary:

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.

Conditions

Older Adults (65 Years and Older)

Hispanic Americans

Cognitive Aging

Aging, Healthy

Exercise

Study ID

NCT06726616

Start date

Mar 19, 2025

Status verified date

Jun, 2026

Completion date

Sep 20, 2027

Anticipated

Primary completion date

Sep 20, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Adult Cohort; n=100 (50 Hispanic American adults and 50 non-Hispanic American adults)

The participants in this PASOS pilot will include 50 self-identified HA individuals and 50 self-identified non-HA individuals between the ages of 55-85 years, with no psychometric evidence of neuropsychological decline. We plan to enroll an equal number of women and men. Race and ethnicity in this study will be determined via self-report or self-identification by participants.

Primary outcome measure

  • Rate of recruitment [ Time Frame: From recruitment to follow-up (1-year) ]

Central Contacts and Locations

Central contacts

Stacey Alvarez-Alvarado, PhD, MS

904-244-9937salvarezalvarado@ufl.edu

Locations

University of Florida, College of Medicine-Jacksonville

Recruiting

Jacksonville, Florida, United States, 32206

Contacts

Stacey Alvarez-Alvarado

904-244-9937salvarezalvarado@ufl.edu

Sol Colindres Solorzano Research Coordinator

9042449711Geminis.ColindresSolorzano@jax.ufl.edu

More Information

Sponsor

University of Florida

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-06-04.