Clinical trial NCT05924529: Alzheimer's Disease and Related Dementias (ADRD) Prevalence in American Samoa
Official title: ADRD Prevalence in American Samoa
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer's Disease and Related Dementia
Lead sponsor: American Samoa Community Cancer Coalition
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: University of Miami
name: University of California, San Francisco
name: University of Hawaii
First posted: 2023-06-29
Enrollment: 1098
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: American Samoa is the only U.S. territory located south of the equator. The 2020 U.S. Census recorded 46,366 residents, with 11,025 (23.8%) of the population age 50 and over. Healthcare in American Samoa is extremely limited with only three government health care providers: 1 hospital, 5 Federally Qualified Health Centers, and Department of Human and Social Services providing WIC, mental health, and nutritional assistance programs. There are only a handful of private healthcare practices: 1 dentist, 2 primary care doctors, and 1 chiropractor. There are no neurologists in American Samoa and only 3 psychiatrists. There is no PET or MRI. There are no known studies documenting ADRD prevalence in the American Samoan population.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Demographic Information and Socioeconomic Status
timeFrame: Demographic information collected will be assessed up to 1 year from when it was collected.
measure: Charlson Comorbidity Index
timeFrame: Charlson co-morbidities will be assessed up to 1 year from when it was collected.
measure: Functional Comorbidity Index (FCI)
timeFrame: Functional Comorbidities will be assessed up to 1 year from when it was collected.
measure: Modified CAID System
timeFrame: mCAIDE index will be assessed up to 1 year from when it was collected.
measure: ADRD Health Literacy
timeFrame: DeLA will be assessed up to 1 year from when it was collected.
measure: Quick Physical Activities Rating
timeFrame: QPAR score will be assessed up to 1 year from the date data was collected.
measure: MIND Diet
timeFrame: MIND Diet score will be assessed up to 1 year from the date data was collected.
measure: Applied Mindfulness Process Scale
timeFrame: MIND Diet score will be assessed up to 1 year from the date data was collected.
measure: ADRD Vulnerability
timeFrame: The VI scores will be assessed up to 1 year from the date the data was collected.
measure: Quick Dementia Rating Scale
timeFrame: Quick Dementia Rating Scale score will be assessed up to 1 year from the date the data was collected.
measure: Number Symbol Coding Task
timeFrame: Number Symbol Coding Task score will be assessed up to 1 year from the date the data was collected.
measure: Dementia Screening Platform
timeFrame: Scores that constitute the dementia screening platformed will be assessed up to 1 year from the date the data was collected.
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Scores of the MoCA-B will be assessed 1 year from the date the data was collected.
measure: Cognivue Clarity
timeFrame: Cognivue clarity scoare will be assessed 1 year from the date the data was collected.
measure: Demographic Information
timeFrame: Demographic information of the participant will be taken 90 days from the day they took the MoCA administered initially.
measure: Medical Evaluation
timeFrame: Medical evaluation should be completed within 90 days from the day the MoCA was administered.
measure: MINT Evaluation
timeFrame: MINT score should be completed and assessed within 90 days from the day the MoCA was administered.
measure: Craft Story Evaluation
timeFrame: Cognitive evaluation should be completed within 90 days from the day the MoCA was administered.
measure: Benson Copy Evaluation
timeFrame: Cognitive evaluation should be completed within 90 days from the day the MoCA was administered.
measure: Category and Letter fluency Evaluation
timeFrame: Cognitive evaluation should be completed within 90 days from the day the MoCA was administered.
measure: Number Forward/Backward Evaluation
timeFrame: Cognitive evaluation should be completed within 90 days from the day the MoCA was administered.
measure: Trailmaking A & B Evaluation
timeFrame: Cognitive evaluation should be completed within 90 days from the day the MoCA was administered.
measure: Noise Pareidoloia Evaluation
timeFrame: Cognitive evaluation should be completed within 90 days from the day the MoCA was administered.
measure: Geriatric Depression Evaluation
timeFrame: Cognitive evaluation should be completed within 90 days from the day the MoCA was administered.
measure: Functional Activities Questionnaire
timeFrame: Cognitive evaluation should be completed within 90 days from the day the MoCA was administered.
measure: Neuropsychiatric Inventory
timeFrame: Cognitive evaluation should be completed within 90 days from the day the MoCA was administered.
measure: Plasma Amyloid-β42
timeFrame: Plasma evaluation should be completed within 90 days from the day the MoCA was administered.
measure: Plasma Amyloid-β40
timeFrame: Plasma evaluation should be completed within 90 days from the day the MoCA was administered.
measure: Plasma P-tau181
timeFrame: Plasma evaluation should be completed within 90 days from the day the MoCA was administered.
measure: Glial Fibrillary Acidic Protein
timeFrame: Plasma evaluation should be completed within 90 days from the day the MoCA was administered.
measure: Neurofilament Light
timeFrame: Plasma evaluation should be completed within 90 days from the day the MoCA was administered.
measure: Synuclein
timeFrame: Plasma evaluation should be completed within 90 days from the day the MoCA was administered.
measure: Genetics
timeFrame: Genetic evaluation should be completed within 90 days from the day the MoCA was administered.
Secondary outcomes:
Other outcomes:
Locations:
city: Pago Pago
country: American Samoa
facility: Malaloa GHC Reid Building
city: Pago Pago
country: American Samoa
facility: Sa'o Fetalai Building
Study officials:
affiliation: American Samoa Community Cancer Coalition
name: Va'atausili Tofaeono, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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