Physical and Cognitive Aging Study in Older Adults

NCT06726616 | Recruiting

• 1 other identifier: IRB202400815
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Rate of recruitment

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

  From recruitment to follow-up (1-year)

Study Arms (1)

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.

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hispanic Americans and Non-Hispanic American adults between the ages of 55 and 85 years old, with at least 8th grade education, and community dwelling.

You may qualify if:

• Hispanic and non-Hispanic adults age 55-85 years, at least 8th grade education, community dwelling.
• Self-identify as Hispanic American
• Report Spanish as primary language • No evidence of dementia or mild cognitive impairment based on cognitive screening \[i.e., Montreal Cognitive Assessment (MoCA) administered during Visit 1; ≥26 among non-Hispanic White, ≥25 among Hispanics, ≥24 among non-Hispanic Blacks (Milani et al., 2018)\]

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida, College of Medicine-Jacksonville

Jacksonville, Florida, 32206, United States

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Stacey Alvarez-Alvarado, PhD, MS

CONTACT

904-244-9937; salvarezalvarado@ufl.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 10, 2024
• Study Start: March 19, 2025
• Primary Completion (Estimated): September 20, 2027
• Study Completion (Estimated): September 20, 2027
• Last Updated: May 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)