Alzheimer Disease (AD)ALOHANCT07180147

Arlington Longitudinal Optimal Healthy Aging Study (ALOHA)

An observational study of Alzheimer Disease (AD) and Cardio Vascular Disease, run by Marymount University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

The Arlington Longitudinal Optimal Healthy Aging (ALOHA) Study is a community-based research project led by the Marymount University Center for Optimal Aging (MCOA). The study is designed to help older adults in the Washington, D.C., Maryland, and Virginia (DMV) area maintain independence, mobility, wellbeing and… Read more about this study

Who is it for?: Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for: Alzheimer Disease (AD), Cardio Vascular Disease, Mild Cognitive Impairment (MCI)
How many people: 500 participants
Where: 1 siteUnited States
Study dates: 1 May 2025to 30 Jul 2031
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 50 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Community-dwelling adults aged 50 years and older living in the Washington, D.C., Maryland, and Virginia metropolitan area. Participants are generally healthy or have manageable chronic conditions and are able to complete physical, cognitive, and psychosocial assessments. Recruitment will emphasize diversity, including racial/ethnic minority groups and individuals from underserved communities, with study materials available in English and Spanish.

Who may be able to join

Age 50 years or older at time of enrollment
Residing in the Washington, District of Columbia (DC)., Maryland, or Virginia metropolitan areas
Community-dwelling (living independently or with minimal assistance)
Able to participate in physical and cognitive assessments
Able to provide informed consent
Willing to return for annual follow-up assessments for up to 5 years

Who cannot join

Diagnosis of dementia or significant cognitive impairment that prevents informed consent or participation in assessments
Severe physical disability or medical condition that precludes participation in study assessments (e.g., unstable cardiac condition, severe mobility limitation)
Current diagnosis of a terminal illness with life expectancy less than 12 months
Residing in a long-term care facility or nursing home at time of enrollment
Inability to communicate in English or Spanish (study materials available in these languages only)
Participation in another interventional trial that could confound study results

Trial locations and contacts

1 site in 1 country.

United States1 site

Center for Optimal Aging, Marymount University
Arlington, Virginia, 22201

Other trials in United States

About this study

Adults aged 50 years and older will receive a comprehensive health assessment at the study site, Center for Optimal Aging- ALOHA Lab at Marymount University (MU) Ballston Campus in Arlington, Virginia. The assessment includes physical and cognitive testing, health and medical history, lifestyle surveys, and biometric measures such as blood pressure, grip strength, body composition by the InBody system, balance and gait speed. Participants will receive their results in a personalized "Health Passport," which summarizes findings and provides tailored recommendations to help manage modifiable health risk factors-such as those linked to Alzheimer's disease, cardiovascular disease, frailty syndrome, and depression.

Participants will return annually for up to 5 years to repeat assessments and receive updated health and wellness recommendations. The study will track changes in health over time and explore the impact of the Health Passport on health behaviors, functional independence, and quality of life. ALOHA will also evaluate the cultural appropriateness of the Health Passport for diverse populations in Northern Virginia.

The program incorporates an interprofessional research model, engaging researchers from multiple health professions to work alongside older adults, supporting both participants' wellness and optimal aging.

Read the detailed description

The Arlington Longitudinal Optimal Healthy Aging (ALOHA) Study is an interdisciplinary, mixed-method, longitudinal research program aimed at identifying, tracking, and managing modifiable health risk factors that influence optimal aging. The study serves community-dwelling adults aged 50 and older living in the DMV region, with initial recruitment focused on healthy individuals without significant cognitive impairment or terminal illness.

The ALOHA framework combines comprehensive baseline and follow-up health assessments with personalized wellness guidance. At enrollment, participants undergo:

Physical health evaluations (vital signs, body composition via bioimpedance, cardiovascular function via arteriography, mobility and endurance tests, grip strength, flexibility, balance)
Cognitive assessments (Montreal Cognitive Assessment, Central Nervous System [CNS] Vital Signs, Wechsler Memory and Intelligence scales, Quality of Life in Neurological Disorders [Neuro-QOL] Cognitive Function survey)
Lifestyle and psychosocial surveys (physical activity, diet quality using the MIND diet score, depression screening via the Center for Epidemiologic Studies Depression Scale [CES-D], social determinants of health, oral health, self-efficacy, quality of life)

Findings are compiled into a tailored, participant-specific, "Health Passport," which summarizes results in accessible language and offers practical, evidence-based recommendations for reducing disease risk, improving physical and cognitive function, and promoting overall wellness.

Participants return annually for up to five years to repeat assessments, receive an updated Health Passport consultation, and complete follow-up surveys regarding adherence, satisfaction, and changes in health status. The longitudinal design allows researchers to examine health trajectories, the effectiveness of early prevention strategies, and the relationship between modifiable risk factors and outcomes such as functional independence and cognitive decline.

Primary study aims:

Identify and track the prevalence of modifiable risk factors for Alzheimer's disease, cardiovascular disease, frailty, and depression.
Provide tailored recommendations to support participant-driven health improvement and evaluate adherence to Health Passport guidance.
Engage older adults and university students in an intergenerational, interprofessional health promotion research model.

The study emphasizes cultural inclusivity, particularly for Northern Virginia's racially and ethnically diverse populations. Spanish-language materials and validated translated assessments are incorporated to support Hispanic/Latino participants.

By integrating clinical, behavioral, and community health approaches, the ALOHA study aims to contribute new evidence on preventive aging strategies, refine the Health Passport model, and expand its use to other communities and academic centers.

Conditions: Alzheimer Disease (AD), Cardio Vascular Disease, Mild Cognitive Impairment (MCI), Frailty Syndrome, Disability Physical, Hypertension
Keywords: Optimal aging, dementia risk factors, Cardiovascular Health, Healthy Aging, Alzheimer Disease Prevention, Lifestyle Intervention, Dementia Risk Reduction, Cognitive Aging, Brain Health, Falls Prevention, Physical Function, Functional Independence, Frailty Prevention, Modifiable Risk Facators
Medical subject headings: Alzheimer Disease, Cognitive Dysfunction, Frailty, Hypertension, Metabolic Syndrome, Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07180147
Study group	Role	What they receive
ALOHA Health Passport Cohort		Community-dwelling adults aged 50 and older who receive a comprehensive baseline and annual health assessment at the Marymount University Center for Optimal Aging. Assessments include physical, cognitive, and psychosocial measures. Results are compiled into a personalized "Health Passport" with tailored recommendations for managing modifiable health risk factors. Participants return annually for up to 5 years to monitor health changes, update recommendations, and complete follow-up surveys on adherence and outcomes.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in adherence to Health Passport recommendations-Physical/Cardiovascular Health (HPAI-PC)
Health Passport Adherence Index (HPAI) Physical/Cardiovascular health; study-specific index. 5-item Likert index (0-4 per item), domain total 0-20; higher = better adherence. Unit: points.
Measured: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in adherence to Health Passport recommendations-Cognitive, Sleep, and Mental Health (HPAI-CSM)
Health Passport Adherence Index (HPAI) for Cognitive, Sleep and Mental Health. 5-item Likert index (0-4 per item), domain total 0-20; higher = better adherence. Unit: points.
Measured: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

Secondary outcomes (25)

Change in Montreal Cognitive Assessment (MoCA) score
The Montreal Cognitive Assessment (MoCA) is a 30-point scale used to assess global cognitive function, including memory, attention, language, and executive function. Higher scores indicate better cognitive performance.
Measured: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in static balance (Four-Stage Balance Test)
Total seconds successfully held across 4 stances (0-40 s); higher = better. Unit: seconds.
Measured: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in adherence to Health Passport recommendations-Diet and Oral Health (HPAI-DO)
Health Passport Adherence Index (HPAI) Diet and Oral Health. 5-item Likert index (0-4 per item), domain total 0-20; higher = better adherence. Unit: points.
Measured: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in adherence to Health Passport recommendations-Social Health (HPAI-SH)
Health Passport Adherence Index (HPAI) for Social Health. 5-item Likert index (0-4 per item), domain total 0-20; higher = better adherence. Unit: points.
Measured: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in walking endurance (200-Meter Fast Walk Test)
Seconds to complete 200 m at fastest safe pace; lower = better. Unit: seconds.
Measured: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in gait speed (10-Meter Walk Test)
Comfortable-pace gait speed over 10 m; meters/second; higher = better. Unit: m/s.
Measured: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in PROMIS-57 Sleep Disturbance
PROMIS-57 Sleep Disturbance T-score (mean 50, SD 10); higher = worse. Unit: T-score.
Measured: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in PROMIS-57 Pain Interference
PROMIS-57 (Patient-Reported Outcomes Measurement Information System.) Pain Interference T-score (mean 50, SD 10); higher = worse. Unit: T-score.
Measured: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in PROMIS-57 Fatigue
PROMIS-57 Fatigue T-score (mean 50, SD 10); higher = worse. Unit: T-score.
Measured: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in PROMIS-57 Depression
PROMIS-57 Depression T-score (mean 50, SD 10); higher = worse. Unit: T-score.
Measured: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in PROMIS-57 Anxiety
PROMIS-57 (Patient-Reported Outcomes Measurement Information System) Anxiety T-score (mean 50, SD 10); higher = worse. Unit: T-score.
Measured: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in PROMIS-57 Satisfaction with Social Roles
PROMIS-57 Satisfaction with Social Roles T-score (mean 50, SD 10); higher = better. Unit: T-score.
Measured: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in PROMIS-57 Physical Function
PROMIS-57 (Patient-Reported Outcomes Measurement Information System) Physical Function T-score (mean 50, SD 10); higher = better function. Unit: T-score.
Measured: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in depressive symptoms (CES-D-20)
Center for Epidemiologic Studies Depression Scale-20 items (0-3 per item based on past-week frequency: 0=rarely/none, 1=some/a little, 2=occasionally/moderate, 3=most/all); total 0-60; higher = worse depressive symptoms. Unit: points.
Measured: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in self-reported cognitive function (Neuro-QOL v2.0 Cognitive Function)
Neuro-QOL (Quality of Life in Neurological Disorders) Cognitive Function T-score (mean 50, SD 10); higher = better cognitive function. Unit: T-score.
Measured: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in falls incidence (self-report)
Number of falls in the prior 12 months, self-reported. Unit: number of falls. Fewer falls indicates a better outcome.
Measured: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in Central Nervous System (CNS) Vital Signs composite scores
CNS Vital Signs is a computerized neurocognitive test battery that evaluates domains such as memory, attention, executive function, and processing speed. Scores are standardized (mean = 100, SD = 15) and age-matched, with higher scores reflecting better function.
Measured: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in systolic and diastolic blood pressure
Resting systolic and diastolic blood pressure will be measured in millimeters of mercury (mmHg) using a standardized sphygmomanometer.
Measured: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in body composition (bioimpedance)
Body composition will be measured using bioelectrical impedance analysis, reporting the percentage (%) body fat and kilograms (kg) lean tissue mass.
Measured: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in MIND Diet Score
The MIND (Mediterranean-DASH Intervention for Neurodegenerative Delay) Diet Score measures adherence to dietary patterns associated with reduced risk of cognitive decline. Scores are based on frequency of consumption of 15 food groups. The total score ranges from 0 to 15, with higher scores indicating greater adherence to the MIND diet and better diet quality.
Measured: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in Timed Up and Go (TUG) test scores
The Timed Up and Go test measures functional mobility. Participants are timed while standing up from a chair, walking 3 meters, turning, walking back, and sitting down. Lower times indicate better mobility.
Measured: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in 6-Minute Walk Test distance
The 6-Minute Walk Test measures functional exercise capacity by recording the distance an individual can walk in 6 minutes on a flat surface. Greater distances, measured in meters (m), indicate better mobility and endurance.
Measured: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in Body Mass Index (BMI)
BMI (kg/m²); numeric measure; interpretation relative to clinical ranges. In most cases, "better" scores are indicated by closer proximity to normal BMI (18.5-24.5), with lower scores indicating an underweight BMI and higher scores indicating an overweight BMI. Unit: kg/m².
Measured: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in oral-health-related quality of life (GOHAI)
Geriatric Oral Health Assessment Index (GOHAI); Score range is 12-60; higher = better oral-health-related quality of life. Unit: points.
Measured: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in perceived stress (A-SDH)
Perceived Stress construct standardized score per A-SDH (All of Us Social Determinants of Health) scoring per U.S. Department of Health and Human Services; higher score = worse stress. Unit: standardized construct score.
Measured: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 202530 Jul 2031

First posted18 Sep 2025
Study start1 May 2025
Primary completion30 Dec 2030 (estimated)
Study completion30 Jul 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (130)Papers the sponsor has linked to this study.
Other trials for Alzheimer Disease (AD)Studies of the same condition, open and under way.
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: 500 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07180147
Sponsor's protocol ID: MUIRB#1238
Other IDs: Potomac Health Foundation
Acronym: ALOHA
Status last verified: Sep 2025
First submitted: 15 Aug 2025
Last updated: 9 Mar 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: IPD used for the resulting publication(s) will be shared.

Publications

Blank K, Gruman C, Robison JT. Case-finding for depression in elderly people: balancing ease of administration with validity in varied treatment settings. J Gerontol A Biol Sci Med Sci. 2004 Apr;59(4):378-84. doi: 10.1093/gerona/59.4.m378.
PubMed 15071082
Ng TKS, Coughlan C, Heyn PC, Tagawa A, Carollo JJ, Kua EH, Mahendran R. Increased plasma brain-derived neurotrophic factor (BDNF) as a potential biomarker for and compensatory mechanism in mild cognitive impairment: a case-control study. Aging (Albany NY). 2021 Oct 15;13(19):22666-22689. doi: 10.18632/aging.203598. Epub 2021 Oct 15.
PubMed 34607976
MacCarthy M, Heyn P, Tagawa A, Carollo J. Walking speed and patient-reported outcomes in young adults with cerebral palsy. Dev Med Child Neurol. 2022 Oct;64(10):1281-1288. doi: 10.1111/dmcn.15225. Epub 2022 Apr 2.
PubMed 35366333
Hegarty, M., Montello, D. R., Richardson, A. E., Ishikawa, T., & Lovelace, K. (2006). Spatial abilities at different scales: Individual differences in aptitude-test performance and spatial-layout learning. Intelligence, 34(2), 151-176. https://doi.org/10.1016/j.intell.2005.09.005
Olabarrieta-Landa L, Rivera D, Galarza-Del-Angel J, Garza MT, Saracho CP, Rodriguez W, Chavez-Oliveros M, Rabago B, Leibach G, Schebela S, Martinez C, Luna M, Longoni M, Ocampo-Barba N, Rodriguez G, Aliaga A, Esenarro L, Garcia de la Cadena C, Perrin BP, Arango-Lasprilla JC. Verbal fluency tests: Normative data for the Latin American Spanish speaking adult population. NeuroRehabilitation. 2015;37(4):515-61. doi: 10.3233/NRE-151279.
PubMed 26639930
Hurtado-Pomares M, Juarez-Leal I, Company-Devesa V, Sanchez-Perez A, Peral-Gomez P, Espinosa-Sempere C, Valera-Gran D, Navarrete-Munoz EM. Psychometric properties of the Spanish version of the Frontal Assessment Battery (FAB-E) and normative values in a representative adult population sample. Neurologia (Engl Ed). 2024 Oct;39(8):694-700. doi: 10.1016/j.nrleng.2022.09.004. Epub 2022 Oct 7.
PubMed 36216225
Arango-Lasprilla JC, Rivera D, Aguayo A, Rodriguez W, Garza MT, Saracho CP, Rodriguez-Agudelo Y, Aliaga A, Weiler G, Luna M, Longoni M, Ocampo-Barba N, Galarza-Del-Angel J, Panyavin I, Guerra A, Esenarro L, Garcia de la Cadena P, Martinez C, Perrin PB. Trail Making Test: Normative data for the Latin American Spanish speaking adult population. NeuroRehabilitation. 2015;37(4):639-61. doi: 10.3233/NRE-151284.
PubMed 26639932
Gollan TH, Garcia DL, Stasenko A, Murillo M, Kim C, Galasko D, Salmon DP. The MINT Sprint 2.0: A picture naming test for detection of naming impairments in Alzheimer's disease and in preclinical AD. Alzheimers Dement. 2024 Jan;20(1):112-123. doi: 10.1002/alz.13381. Epub 2023 Jul 19.
PubMed 37464962
He Z, Dieciuc M, Carr D, Chakraborty S, Singh A, Fowe IE, Zhang S, Lustria MLA, Terracciano A, Charness N, Boot WR. New Opportunities for the Early Detection and Treatment of Cognitive Decline: Adherence Challenges and the Promise of Smart and Person-Centered Technologies. BMC Digit Health. 2023;1:7. doi: 10.1186/s44247-023-00008-1. Epub 2023 Feb 14.
PubMed 40093660
Olivari BS, Baumgart M, Lock SL, Whiting CG, Taylor CA, Iskander J, Thorpe P, McGuire LC. CDC Grand Rounds: Promoting Well-Being and Independence in Older Adults. MMWR Morb Mortal Wkly Rep. 2018 Sep 21;67(37):1036-1039. doi: 10.15585/mmwr.mm6737a4.
PubMed 30235185
Visscher TL, Seidell JC, Molarius A, van der Kuip D, Hofman A, Witteman JC. A comparison of body mass index, waist-hip ratio and waist circumference as predictors of all-cause mortality among the elderly: the Rotterdam study. Int J Obes Relat Metab Disord. 2001 Nov;25(11):1730-5. doi: 10.1038/sj.ijo.0801787.
PubMed 11753597
Ma W, Zhu H, Yu X, Zhai X, Li S, Huang N, Liu K, Shirai K, Sheerah HA, Cao J. Association between android fat mass, gynoid fat mass and cardiovascular and all-cause mortality in adults: NHANES 2003-2007. Front Cardiovasc Med. 2023 May 18;10:1055223. doi: 10.3389/fcvm.2023.1055223. eCollection 2023.
PubMed 37273879
Abellan van Kan G, Rolland Y, Andrieu S, Bauer J, Beauchet O, Bonnefoy M, Cesari M, Donini LM, Gillette Guyonnet S, Inzitari M, Nourhashemi F, Onder G, Ritz P, Salva A, Visser M, Vellas B. Gait speed at usual pace as a predictor of adverse outcomes in community-dwelling older people an International Academy on Nutrition and Aging (IANA) Task Force. J Nutr Health Aging. 2009 Dec;13(10):881-9. doi: 10.1007/s12603-009-0246-z.
PubMed 19924348
Bohannon RW. Reference values for the timed up and go test: a descriptive meta-analysis. J Geriatr Phys Ther. 2006;29(2):64-8. doi: 10.1519/00139143-200608000-00004.
PubMed 16914068
Rossiter-Fornoff JE, Wolf SL, Wolfson LI, Buchner DM. A cross-sectional validation study of the FICSIT common data base static balance measures. Frailty and Injuries: Cooperative Studies of Intervention Techniques. J Gerontol A Biol Sci Med Sci. 1995 Nov;50(6):M291-7. doi: 10.1093/gerona/50a.6.m291.
PubMed 7583799

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Arlington Longitudinal Optimal Healthy Aging Study (ALOHA)
ClinicalTrials.gov ID: NCT07180147
Acronym / sponsor ID: ALOHA / MUIRB#1238
Conditions: Alzheimer Disease (AD), Cardio Vascular Disease, Mild Cognitive Impairment (MCI), Frailty Syndrome, Disability Physical, Hypertension
Keywords: Optimal aging, dementia risk factors, Cardiovascular Health, Healthy Aging, Alzheimer Disease Prevention, Lifestyle Intervention, Dementia Risk Reduction, Cognitive Aging
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 500 participants (estimated)
Lead sponsor: Marymount UniversityUniversity, hospital or other
Collaborators: Potomac Health Foundations
Study start: 1 May 2025 (actual)
Primary completion: 30 Dec 2030 (estimated)
Study completion: 30 Jul 2031 (estimated)
First posted: 18 Sep 2025 (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.

Detailed description

The ALOHA framework combines comprehensive baseline and follow-up health assessments with personalized wellness guidance. At enrollment, participants undergo:

Physical health evaluations (vital signs, body composition via bioimpedance, cardiovascular function via arteriography, mobility and endurance tests, grip strength, flexibility, balance)
Cognitive assessments (Montreal Cognitive Assessment, Central Nervous System [CNS] Vital Signs, Wechsler Memory and Intelligence scales, Quality of Life in Neurological Disorders [Neuro-QOL] Cognitive Function survey)
Lifestyle and psychosocial surveys (physical activity, diet quality using the MIND diet score, depression screening via the Center for Epidemiologic Studies Depression Scale [CES-D], social determinants of health, oral health, self-efficacy, quality of life)

Primary study aims:

Identify and track the prevalence of modifiable risk factors for Alzheimer's disease, cardiovascular disease, frailty, and depression.
Provide tailored recommendations to support participant-driven health improvement and evaluate adherence to Health Passport guidance.
Engage older adults and university students in an intergenerational, interprofessional health promotion research model.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
ALOHA Health Passport Cohort	–	–Community-dwelling adults aged 50 and older who receive a comprehensive baseline and annual health assessment at the Marymount University Center for Optimal Aging. Assessments include physical, cognitive, and psychosocial measures. Results are compiled into a personalized "Health Passport" with tailored recommendations for managing modifiable health risk factors. Participants return annually for up to 5 years to monitor health changes, update recommendations, and complete follow-up surveys on adherence and outcomes.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Community-dwelling adults aged 50 years and older living in the Washington, D.C., Maryland, and Virginia metropolitan area. Participants are generally healthy or have manageable chronic conditions and are able to complete physical, cognitive, and psychosocial assessments. Recruitment will emphasize diversity, including racial/ethnic minority groups and individuals from underserved communities, with study materials available in English and Spanish.

Key inclusion criteria (6 listed)

Age 50 years or older at time of enrollment
Residing in the Washington, District of Columbia (DC)., Maryland, or Virginia metropolitan areas
Community-dwelling (living independently or with minimal assistance)
Able to participate in physical and cognitive assessments
Able to provide informed consent

Key exclusion criteria (6 listed)

Diagnosis of dementia or significant cognitive impairment that prevents informed consent or participation in assessments
Severe physical disability or medical condition that precludes participation in study assessments (e.g., unstable cardiac condition, severe mobility limitation)
Current diagnosis of a terminal illness with life expectancy less than 12 months
Residing in a long-term care facility or nursing home at time of enrollment
Inability to communicate in English or Spanish (study materials available in these languages only)

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

Change in adherence to Health Passport recommendations-Physical/Cardiovascular Health (HPAI-PC)
Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Health Passport Adherence Index (HPAI) Physical/Cardiovascular health; study-specific index. 5-item Likert index (0-4 per item), domain total 0-20; higher = better adherence. Unit: points.
Change in adherence to Health Passport recommendations-Cognitive, Sleep, and Mental Health (HPAI-CSM)
Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Health Passport Adherence Index (HPAI) for Cognitive, Sleep and Mental Health. 5-item Likert index (0-4 per item), domain total 0-20; higher = better adherence. Unit: points.

25 secondary outcomes

Change in Montreal Cognitive Assessment (MoCA) score
Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in static balance (Four-Stage Balance Test)
Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in adherence to Health Passport recommendations-Diet and Oral Health (HPAI-DO)
Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in adherence to Health Passport recommendations-Social Health (HPAI-SH)
Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in walking endurance (200-Meter Fast Walk Test)
Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in gait speed (10-Meter Walk Test)
Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in PROMIS-57 Sleep Disturbance
Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in PROMIS-57 Pain Interference
Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in PROMIS-57 Fatigue
Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in PROMIS-57 Depression
Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in PROMIS-57 Anxiety
Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in PROMIS-57 Satisfaction with Social Roles
Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in PROMIS-57 Physical Function
Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in depressive symptoms (CES-D-20)
Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in self-reported cognitive function (Neuro-QOL v2.0 Cognitive Function)
Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in falls incidence (self-report)
Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in Central Nervous System (CNS) Vital Signs composite scores
Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in systolic and diastolic blood pressure
Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in body composition (bioimpedance)
Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in MIND Diet Score
Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in Timed Up and Go (TUG) test scores
Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in 6-Minute Walk Test distance
Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in Body Mass Index (BMI)
Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in oral-health-related quality of life (GOHAI)
Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).
Change in perceived stress (A-SDH)
Time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).

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 9 Mar 2026.
Background: PubMed 15071082Blank K, Gruman C, Robison JT. Case-finding for depression in elderly people: balancing ease of administration with validity in varied treatment settings. J Gerontol A Biol Sci Med Sci. 2004 Apr;59(4):378-84. doi: 10.1093/gerona/59.4.m378.
Background: PubMed 34607976Ng TKS, Coughlan C, Heyn PC, Tagawa A, Carollo JJ, Kua EH, Mahendran R. Increased plasma brain-derived neurotrophic factor (BDNF) as a potential biomarker for and compensatory mechanism in mild cognitive impairment: a case-control study. Aging (Albany NY). 2021 Oct 15;13(19):22666-22689. doi: 10.18632/aging.203598. Epub 2021 Oct 15.
Background: PubMed 35366333MacCarthy M, Heyn P, Tagawa A, Carollo J. Walking speed and patient-reported outcomes in young adults with cerebral palsy. Dev Med Child Neurol. 2022 Oct;64(10):1281-1288. doi: 10.1111/dmcn.15225. Epub 2022 Apr 2.
BackgroundHegarty, M., Montello, D. R., Richardson, A. E., Ishikawa, T., & Lovelace, K. (2006). Spatial abilities at different scales: Individual differences in aptitude-test performance and spatial-layout learning. Intelligence, 34(2), 151-176. https://doi.org/10.1016/j.intell.2005.09.005
Background: PubMed 26639930Olabarrieta-Landa L, Rivera D, Galarza-Del-Angel J, Garza MT, Saracho CP, Rodriguez W, Chavez-Oliveros M, Rabago B, Leibach G, Schebela S, Martinez C, Luna M, Longoni M, Ocampo-Barba N, Rodriguez G, Aliaga A, Esenarro L, Garcia de la Cadena C, Perrin BP, Arango-Lasprilla JC. Verbal fluency tests: Normative data for the Latin American Spanish speaking adult population. NeuroRehabilitation. 2015;37(4):515-61. doi: 10.3233/NRE-151279.
Background: PubMed 36216225Hurtado-Pomares M, Juarez-Leal I, Company-Devesa V, Sanchez-Perez A, Peral-Gomez P, Espinosa-Sempere C, Valera-Gran D, Navarrete-Munoz EM. Psychometric properties of the Spanish version of the Frontal Assessment Battery (FAB-E) and normative values in a representative adult population sample. Neurologia (Engl Ed). 2024 Oct;39(8):694-700. doi: 10.1016/j.nrleng.2022.09.004. Epub 2022 Oct 7.
Background: PubMed 26639932Arango-Lasprilla JC, Rivera D, Aguayo A, Rodriguez W, Garza MT, Saracho CP, Rodriguez-Agudelo Y, Aliaga A, Weiler G, Luna M, Longoni M, Ocampo-Barba N, Galarza-Del-Angel J, Panyavin I, Guerra A, Esenarro L, Garcia de la Cadena P, Martinez C, Perrin PB. Trail Making Test: Normative data for the Latin American Spanish speaking adult population. NeuroRehabilitation. 2015;37(4):639-61. doi: 10.3233/NRE-151284.
Background: PubMed 37464962Gollan TH, Garcia DL, Stasenko A, Murillo M, Kim C, Galasko D, Salmon DP. The MINT Sprint 2.0: A picture naming test for detection of naming impairments in Alzheimer's disease and in preclinical AD. Alzheimers Dement. 2024 Jan;20(1):112-123. doi: 10.1002/alz.13381. Epub 2023 Jul 19.
Background: PubMed 40093660He Z, Dieciuc M, Carr D, Chakraborty S, Singh A, Fowe IE, Zhang S, Lustria MLA, Terracciano A, Charness N, Boot WR. New Opportunities for the Early Detection and Treatment of Cognitive Decline: Adherence Challenges and the Promise of Smart and Person-Centered Technologies. BMC Digit Health. 2023;1:7. doi: 10.1186/s44247-023-00008-1. Epub 2023 Feb 14.
Background: PubMed 30235185Olivari BS, Baumgart M, Lock SL, Whiting CG, Taylor CA, Iskander J, Thorpe P, McGuire LC. CDC Grand Rounds: Promoting Well-Being and Independence in Older Adults. MMWR Morb Mortal Wkly Rep. 2018 Sep 21;67(37):1036-1039. doi: 10.15585/mmwr.mm6737a4.
Background: PubMed 11753597Visscher TL, Seidell JC, Molarius A, van der Kuip D, Hofman A, Witteman JC. A comparison of body mass index, waist-hip ratio and waist circumference as predictors of all-cause mortality among the elderly: the Rotterdam study. Int J Obes Relat Metab Disord. 2001 Nov;25(11):1730-5. doi: 10.1038/sj.ijo.0801787.
Background: PubMed 37273879Ma W, Zhu H, Yu X, Zhai X, Li S, Huang N, Liu K, Shirai K, Sheerah HA, Cao J. Association between android fat mass, gynoid fat mass and cardiovascular and all-cause mortality in adults: NHANES 2003-2007. Front Cardiovasc Med. 2023 May 18;10:1055223. doi: 10.3389/fcvm.2023.1055223. eCollection 2023.
The Arlington Longitudinal Optimal Healthy Aging Study is a research initiative led by health experts at Marymount University. This timely study provides a comprehensive academic-to-community health program designed to enhance old wellbeing.Link provided by the sponsor.
Join the ALOHA Study and Help Us Understand Optimal Aging in the DMV Area!Link provided by the sponsor.
Individual participant dataSharing planned: Yes. IPD used for the resulting publication(s) will be shared.

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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. This study is not recruiting at the moment.

Patricia C Heyn, PhD, FGSA, FACRM principal investigator

Office of Research, Marymount University

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 Alzheimer Disease (AD) and Cardio Vascular Disease, run by Marymount University 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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 9 Mar 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in adherence to Health Passport recommendations-Physical/Cardiovascular Health (HPAI-PC) (time frame: Baseline and 12 months (with annual re-testing up to 5 years, per protocol).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07180147, which also lists 130 linked publications.

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 9 Mar 2026.