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

Alzheimer's Disease and Related Dementia Clinical Trial

Official title:

ADRD Prevalence in American Samoa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05924529
• Other study ID #: ASCCC0191792
• Status: Recruiting
• Start date: September 30, 2022
• Est. completion date: September 2025

Study information

• Verified date: June 2023
• Source: American Samoa Community Cancer Coalition
• Contact: Siumu Fa'ai'uaso, BS
• Phone: 1-684-699-0110
• Email: sfaaiuaso[@]cancercoalition.as
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1098
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease and Related Dementia
• Dementia

Locations

Country	Name	City	State
American Samoa	Malaloa GHC Reid Building	Pago Pago
American Samoa	Sa'o Fetalai Building	Pago Pago

Sponsors (5)

Lead Sponsor	Collaborator
American Samoa Community Cancer Coalition	National Institutes of Health (NIH), University of California, San Francisco, University of Hawaii, University of Miami

Country where clinical trial is conducted

American Samoa, 

References & 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. — View 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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	Medical evaluation should be completed within 90 days from the day the MoCA was administered.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	Neuropsychiatric Inventory	Neropsychiatric Inventory to assess behavior.	Cognitive evaluation should be completed within 90 days from the day the MoCA was administered.
Primary	Plasma Amyloid-ß42	ADRD plasma biomarkers will be analyzed by MagQu Ltd to measure plasma Aß42 using the Simoa Human assays (Quanterix Corporation, Billerica, MA) on the Simoa™ HD-X. The 42 amino acid form of amyloid-ß (Aß42) 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.
Primary	Plasma Amyloid-ß40	ADRD plasma biomarkers will be analyzed by MagQu Ltd to measure plasma Aß40 using the Simoa Human assays (Quanterix Corporation, Billerica, MA) on the Simoa™ HD-X. Amyloid ß (Aß) is known as a biomarker for AD, and the CSF Aß40 / Aß42 ratio is clinically useful for diagnosis of AD.	Plasma evaluation should be completed within 90 days from the day the MoCA was administered.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.