Alzheimer's Disease and Related Dementias (ADRD) Prevalence in American Samoa

NCT ID: NCT05924529

Last Updated: 2023-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1098 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-30

Study Completion Date

2025-09-30

Brief Summary

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The goal of this study is to learn about ADRD prevalence within the Samoan population. Participants will be administered a series of cognitive assessments to determine cognitive status and a population-based prevalence of Mild Cognitive Impairment (MCI) and ADRD. Blood samples will also be collected from the participants for genetic and plasma biomarker analysis.

Detailed Description

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This study aims to do the following:

Test ADRD knowledge, health literacy, research readiness and determine ADRD resilience and vulnerability factors, and cognitive status in a probability sample of 981 Samoans age 50+ using culturally adapted instruments in our probability sample.

Conduct Gold Standard evaluations in our probability sample using the Uniform Data Set (UDSv3.0) from the National Institute on Aging (NIA) Alzheimer's Disease Research Center program to determine a population-based prevalence of MCI and ADRD for harmonization, data sharing, and comparison to other groups, and,

Cross-validate Gold Standard dementia evaluations with genetic (i.e., ApoE) and plasma Amyloid-Tau-Neuronal Injury/Neurodegeneration (ATN) framework biomarkers in our probability sample and compare to information available for other racial/ethnic groups.

Conditions

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Alzheimer's Disease and Related Dementia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Samoans in American Samoa

Cognitive assessments will be administered to all participants to assess cognitive status. Gold standard evaluations will be administered to cross-validate the results of the cognitive assessments. Blood will be extracted from all participants to cross-validate results from the prior cognitive assessments and Gold Standard evaluations and conduct plasma and genetic analysis.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age 50 or older
* Community dwelling
* Speaks English or Samoan
* Willing to contribute a biomarker specimen

Exclusion Criteria

* Residing in Assistant Living or Skilled Nursing Facility
* Axis 1 Psychiatric diagnosis (e.g., Schizophrenia, Bipolar)
* Unstable medical condition (i.e., metastatic cancer) that could preclude completion of study visit
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

University of Hawaii

OTHER

Sponsor Role collaborator

American Samoa Community Cancer Coalition

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Va'atausili Tofaeono, MS

Role: PRINCIPAL_INVESTIGATOR

American Samoa Community Cancer Coalition

Locations

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Malaloa GHC Reid Building

Pago Pago, , American Samoa

Site Status RECRUITING

Sa'o Fetalai Building

Pago Pago, , American Samoa

Site Status RECRUITING

Countries

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American Samoa

Central Contacts

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Siumu Fa'ai'uaso, BS

Role: CONTACT

Phone: 1-684-699-0110

Email: [email protected]

Casuallen Atuatasi, PhD

Role: CONTACT

Phone: 1-684-699-0110

Email: [email protected]

Facility Contacts

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Casuallen Atuatasi, PhD

Role: primary

Siumu Fa'ai'uaso, BS

Role: backup

Casuallen Atuatasi, PhD

Role: primary

Siumu Fa'ai'uaso, BS

Role: backup

References

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Tofaeono V, Ka'opua LSI, Sy A, Terada T, Taliloa-Vai Purcell R, Aoelua-Fanene S, Tong K, Tofaeono V, Unutoa-Mageo T, Scanlan L, Cassel K, Rosario A. Research Capacity Strengthening in American Samoa: Fa'avaeina le Fa'atelega o le Tomai Sa'ili'ili i Amerika Samoa. Br J Soc Work. 2020 Mar;50(2):525-547. doi: 10.1093/bjsw/bcz160. Epub 2019 Dec 31.

Reference Type BACKGROUND
PMID: 32280149 (View on PubMed)

Williams S, Graupner J, Fernandes R, Gorawara-Bhat R. Healthcare providers attitudes and knowledge toward dementia in American Samoan culture. J Pain Sym Man 55:P680, 2017

Reference Type BACKGROUND

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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ASCCC0191792

Identifier Type: -

Identifier Source: org_study_id