Older Adults (65 Years and Older)PASOSNCT06726616
Physical and Cognitive Aging Study in Older Adults
An observational study of Older Adults (65 Years and Older) and Hispanic Americans, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Older Adults (65 Years and Older), Hispanic Americans, Cognitive Aging
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2025to 20 Sep 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)]
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida, College of Medicine-Jacksonville
Jacksonville, Florida, 32206
Stacey Alvarez-Alvarado, 904-244-9937, salvarezalvarado@ufl.edu
Sol Colindres Solorzano Research Coordinator, 9042449711, Geminis.ColindresSolorzano@jax.ufl.edu
About this study
Official title: PASOS: 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.
Read the detailed description
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).
- Conditions
- Older Adults (65 Years and Older), Hispanic Americans, Cognitive Aging, Aging, Healthy, Exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recruitment
Recruiting > 80% participants (50 Hispanic American and 50 non-Hispanic American adults) for a longitudinal aging study.
Measured: From recruitment to follow-up (1-year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start19 Mar 2025
- Primary completion20 Sep 2027 (estimated)
- Study completion20 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older Adults (65 Years and Older)Studies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726616
- Sponsor's protocol ID
- IRB202400815
- Acronym
- PASOS
- Status last verified
- Jun 2026
- First submitted
- 2 Dec 2024
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PASOS: Physical and Cognitive Aging Study in Older Adults
- ClinicalTrials.gov ID
- NCT06726616
- Acronym / sponsor ID
- PASOS / IRB202400815
- Conditions
- Older Adults (65 Years and Older), Hispanic Americans, Cognitive Aging, Aging, Healthy, Exercise
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 20 Sep 2027 (estimated)
- Study completion
- 20 Sep 2027 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)]
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Older Adults (65 Years and Older) and Hispanic Americans, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stacey Alvarez-Alvarado, PhD, MS (904-244-9937, salvarezalvarado@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of recruitment (time frame: From recruitment to follow-up (1-year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.