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

NCT05924529 | Unknown

• 1 other identifier: ASCCC0191792
• Study Type: observational
• Target: 1,098
• Locations: 1 country
• Sites: 2

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.

Conditions

Alzheimer's Disease and Related Dementia

Outcome Measures

Primary Outcomes (33)

• Demographic Information and Socioeconomic Status

  Information on sociodemographic, primary language, medical and injury history, review of systems, medications, alcohol/tobacco/substance use history, exposure history, co-morbidities, social and family history are collected to determine the socioeconomic status of the participant. Socioeconomic status is determined by calculating the combined education and occupation attainment scores from the Hollingshead Two-Factor Index. This information will be aggregated to understand the socioeconomic status of the participant.

  Demographic information collected will be assessed up to 1 year from when it was collected.

• Charlson Comorbidity Index

  The Charlson Comorbidity Index is a method of categorizing comorbidities of patients based on the International Classification of Diseases (ICD) diagnosis codes. Each comorbidity category has an associated weight (from 1 to 6) and the sum of all the weights results in a single comorbidity score for a patient. A score of zero indicates that no comorbidities were found. The higher the score, the more likely the predicted outcome will result in mortality or higher resource use.

  Charlson co-morbidities will be assessed up to 1 year from when it was collected.

• Functional Comorbidity Index (FCI)

  The Functional Comorbidity index (FCI) has been designed specifically in relation to physical function and is easier and more intuitive to use. It includes 18 diagnoses, counting their presence or absence, resulting in a cumulative sum score: the number of comorbidities.

  Functional Comorbidities will be assessed up to 1 year from when it was collected.

• Modified CAID System

  Modified CAIDE (mCAIDE) system and test its ability to predict presence, severity, and etiology of cognitive impairment in older adults. Higher mCAIDE quartiles were associated with lower performance on global and domain-specific cognitive tests.

  mCAIDE index will be assessed up to 1 year from when it was collected.

• ADRD Health Literacy

  Dementia Literacy Assessment (DELA) consists of 25 items scored 0=incorrect/1=correct. Total DELA score ranges from 0 to 25 with a higher score being indicative of greater dementia literacy.

  DeLA will be assessed up to 1 year from when it was collected.

• Quick Physical Activities Rating

  The Quick Physical Activities Rating (QPAR) as an informant-rated instrument to quantify the dosage of physical activities in healthy controls. The higher the score, the better the participant's physical activity is. The lower the score, the lower the participant's physical activity.

  QPAR score will be assessed up to 1 year from the date data was collected.

• MIND Diet

  A MIND diet score was developed to identify foods and nutrients, along with daily serving sizes, related to protection against dementia and cognitive decline. The MIND diet identified fifteen dietary components that were classified as either "brain healthy" or as unhealthy. Participants with the highest MIND diet scores had a significantly slower rate of cognitive decline compared with those with the lowest scores.

  MIND Diet score will be assessed up to 1 year from the date data was collected.

• Applied Mindfulness Process Scale

  The Applied Mindfulness Process Scale (AMPS) is a process measure used to quantify how participants in mindfulness-based interventions (MBIs) use mindfulness practice when facing challenges in daily life.

  MIND Diet score will be assessed up to 1 year from the date data was collected.

• ADRD Vulnerability

  The Vulnerability Index (VI) was designed to identify individuals who are at risk of developing cognitive impairment in the future, capturing 12 sociodemographic variables and modifiable medical comorbidities associated with higher ADRD risk. A weighted measure of the contributions of age, sex, race, education, depression, blood pressure, obesity, diabetes, stroke, heart disease, hypercholesterolemia, and frailty to ADRD risk. The VI has the possible range of scores from 2-20 with higher scores representing higher brain vulnerability with a published cut-off of 8.

  The VI scores will be assessed up to 1 year from the date the data was collected.

• Quick Dementia Rating Scale

  The Quick Dementia Rating Scale is a 10-item questionnaire completed by an informant without the need for a trained clinician or rater, and takes 3 to 5 minutes to complete. Scores range from 0 to 30 with higher scores representing greater cognitive impairment.

  Quick Dementia Rating Scale score will be assessed up to 1 year from the date the data was collected.

• Number Symbol Coding Task

  The Number Symbol Coding Task is a brief, 90-second executive task that incorporates attention, planning and set-switching that can be completed by individuals into the moderate-to-severe stages of dementia. The Number Symbol Coding Task score are between 0-70 where higher scores can distinguish between normal controls, MCI and ADRD.

  Number Symbol Coding Task score will be assessed up to 1 year from the date the data was collected.

• Dementia Screening Platform

  The platform combines the QDRS, NSCT, RI and VI to discriminate between normal controls, MCI and ADRD.

  Scores that constitute the dementia screening platformed will be assessed up to 1 year from the date the data was collected.

• Montreal Cognitive Assessment (MoCA)

  The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total possible score is 30 points; a score of 26 or above is considered normal.

  Scores of the MoCA-B will be assessed 1 year from the date the data was collected.

• Cognivue Clarity

  Cognivue Clarity evaluates 6 cognitive domains: visuospatial, executive function/attention, naming/language, memory, delayed recall and abstraction. Cognivue Clarity also measures two speed performance parameters: reaction time and speed processing. Scores that ≥ 75: Normal Cognitive Function, 51-74: Low Cognitive Impairment and ≤ 50: Moderate-Severe Cognitive Impairment.

  Cognivue clarity scoare will be assessed 1 year from the date the data was collected.

• Demographic Information

  Updated information on sociodemographic data using UDSv3.0 forms.

  Demographic information of the participant will be taken 90 days from the day they took the MoCA administered initially.

• Medical Evaluation

  A physical and neurological examination will be completed in which the Modified Hachinski Scale will be used to assess vascular risks. Participants scoring 7 or greater are classified as having "multi-infarct dementia", and patients scoring \</= 4 are classified as having "primary degenerative dementia". A score of 5 or 6 is considered as an intermediate value and is usually designated as "mixed dementia".

  Medical evaluation should be completed within 90 days from the day the MoCA was administered.

• MINT Evaluation

  The Multilingual Naming Test (MINT) is a picture naming test to detect naming impairment (i.e., dysnomia) across stages of Alzheimer's disease (AD). The number of spontaneous correct responses and correct responses following a semantic cue are summed to give a total score. Thus, the abbreviated MINT total scores range from 0 to 32 and these were used as the primary outcome measure. Individuals with a low score on MINT are generally less effective and tend to exhibit undesirable behaviors such as unauthorized absence, inappropriate behavior and an irresponsible approach to rules and regulations. People with a high score at MINT are generally considered to be high-performing, both in the handling of work tasks and working relationships.

  MINT score should be completed and assessed within 90 days from the day the MoCA was administered.

• Craft Story Evaluation

  Craft story immediate, delayed and cued paragraph recall assesses the ability to recall a short story that was read to them 20 minutes ago.

  Cognitive evaluation should be completed within 90 days from the day the MoCA was administered.

• Benson Copy Evaluation

  Benson Copy assesses visuospatial and constructional ability/skills. Benson Copy Test

  Cognitive evaluation should be completed within 90 days from the day the MoCA was administered.

• Category and Letter fluency Evaluation

  Category and Letter fluency assesses verbal fluency and language (semantic memory).

  Cognitive evaluation should be completed within 90 days from the day the MoCA was administered.

• Number Forward/Backward Evaluation

  Number forward measures capacity for holding information briefly for the purpose of repeating exactly. Number backward measures ability to hold information and manipulate the numbers by reversing the sequence.

  Cognitive evaluation should be completed within 90 days from the day the MoCA was administered.

• Trailmaking A & B Evaluation

  Trailmaking A \& B assesses attention/processing speed, and executive function/cognitive flexibility. Activity: Part A - The examiner instructs the participant to connect the circles (number 1 through 25) with a drawn line in ascending order as quickly as possible. Part B - The examiner instructs the participant to connect alphanumeric circles with a drawn line in ascending order as quickly as possible.

  Cognitive evaluation should be completed within 90 days from the day the MoCA was administered.

• Noise Pareidoloia Evaluation

  Noise-Pareidoloia Test is a tool that evokes visual hallucination-like illusions, and these illusions may be a surrogate marker of visual hallucinations.

  Cognitive evaluation should be completed within 90 days from the day the MoCA was administered.

• Geriatric Depression Evaluation

  Geriatric Depression Scale is a patient-reported outcome measure created to screen for depressive symptoms among older adults. The GDS is a multidimensional, multidisciplinary diagnostic and therapeutic activity that helps find patients at risk of/with depression. Scores of 1 to 5 is normal. Higher scores suggests more depression.

  Cognitive evaluation should be completed within 90 days from the day the MoCA was administered.

• Functional Activities Questionnaire

  Functional Activities Questionnaire to assess activities of daily living.

  Cognitive evaluation should be completed within 90 days from the day the MoCA was administered.

• Neuropsychiatric Inventory

  Neropsychiatric Inventory to assess behavior.

  Cognitive evaluation should be completed within 90 days from the day the MoCA was administered.

• Plasma Amyloid-β42

  ADRD plasma biomarkers will be analyzed by MagQu Ltd to measure plasma Aβ42 using the Simoa Human assays (Quanterix Corporation, Billerica, MA) on the Simoa™ HD-X. The 42 amino acid form of amyloid-β (Aβ42) plays a key role in the pathogenesis of Alzheimer's disease (AD) and is a core biomarker for the diagnosis of AD.

  Plasma evaluation should be completed within 90 days from the day the MoCA was administered.

• Plasma Amyloid-β40

  ADRD plasma biomarkers will be analyzed by MagQu Ltd to measure plasma Aβ40 using the Simoa Human assays (Quanterix Corporation, Billerica, MA) on the Simoa™ HD-X. Amyloid β (Aβ) is known as a biomarker for AD, and the CSF Aβ40 / Aβ42 ratio is clinically useful for diagnosis of AD.

  Plasma evaluation should be completed within 90 days from the day the MoCA was administered.

• Plasma P-tau181

  ADRD plasma biomarkers will be analyzed by MagQu Ltd to measure p-tau-181 using the Simoa Human assays (Quanterix Corporation, Billerica, MA) on the Simoa™ HD-X to measure neuronal injury. Plasma P-tau181 is a noninvasive diagnostic and prognostic biomarker of AD.

  Plasma evaluation should be completed within 90 days from the day the MoCA was administered.

• Glial Fibrillary Acidic Protein

  ADRD plasma biomarkers will be analyzed by MagQu Ltd to measure Glial Fibrillary Acidic Protein using the Simoa Human assays (Quanterix Corporation, Billerica, MA) on the Simoa™ HD-X to measure neuronal injury.

  Plasma evaluation should be completed within 90 days from the day the MoCA was administered.

• Neurofilament Light

  ADRD plasma biomarkers will be analyzed by MagQu Ltd will measure neuronal injury neurofilament light with the Simoa Human assays (Quanterix Corporation, Billerica, MA) on the Simoa™ HD-X.

  Plasma evaluation should be completed within 90 days from the day the MoCA was administered.

• Synuclein

  ADRD plasma biomarkers will be analyzed by MagQu Ltd will measure Alpha Synuclein using the Simoa™Human assays (Quanterix Corporation, Billerica, MA) on the Simoa™ HD-X.

  Plasma evaluation should be completed within 90 days from the day the MoCA was administered.

• Genetics

  We will conduct several analyses taking in account the limitations of small sample size, including genotyping, whole genome sequencings (WGS), preliminary novel gene variant exploration, and local ancestry. All samples will be genotyped using GSA Illumina array at the HIHG Center for Genome Technology (CGT)

  Genetic evaluation should be completed within 90 days from the day the MoCA was administered.

Study Arms (1)

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.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• American Samoa Community Cancer Coalition: lead
• National Institutes of Health (NIH): collaborator
• University of Miami: collaborator
• University of California, San Francisco: collaborator
• University of Hawaii: collaborator

Study Sites (2)

Malaloa GHC Reid Building

Pago Pago, 96799, American Samoa

RECRUITING

Sa'o Fetalai Building

Pago Pago, 96799, American Samoa

RECRUITING

Related Publications (2)

• 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.

  PMID: 32280149 BACKGROUND

• 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

  BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

This study will collect blood samples from participants in which some whole blood will be spun down for plasma extraction, some of it will be sent in whole blood form to a laboratory for analysis and the remaining will be stored in repository.

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Va'atausili Tofaeono, MS

  American Samoa Community Cancer Coalition

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Siumu Fa'ai'uaso, BS

CONTACT

1-684-699-0110; sfaaiuaso@cancercoalition.as

Casuallen Atuatasi, PhD

CONTACT

1-684-699-0110; catuatasi@cancercoalition.as

Study Design

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

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: June 29, 2023
• Study Start: September 30, 2022
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: After study has been completed.
• Access Criteria: The database may be attractive for the evaluation of prevalence, impact, and potential therapies for age-related diseases. We will develop a process wherein formal proposals to conduct clinical trials or other studies with the cohort are evaluated and approved.

Locations

AM (2)