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

Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

ADRD Prevalence in American Samoa

ClinicalTrials.gov ID

NCT05924529

Acronym / sponsor ID

ASCCC0191792

Conditions

Alzheimer's Disease and Related Dementia

Study type

Observational

Recruitment status

Unknown status

Enrolment

1,098 participants (estimated)

Lead sponsor

American Samoa Community Cancer CoalitionUniversity, hospital or other

Collaborators

National Institutes of Health (NIH), University of Miami, University of California, San Francisco, University of Hawaii

Study start

30 Sep 2022 (actual)

Primary completion

Sep 2025 (estimated)

Study completion

Sep 2025 (estimated)

First posted

29 Jun 2023 (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.

Study design

Observational model

Cohort

Time perspective

Prospective

Number of arms

1

Who may qualify

Ages

50 years and older

Sex

All

Age groups

Adult, Older adult

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.

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

1. Demographic Information and Socioeconomic Status

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

   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.

2. Charlson Comorbidity Index

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

   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.

3. Functional Comorbidity Index (FCI)

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

   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.

4. Modified CAID System

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

   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.

5. ADRD Health Literacy

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

   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.

6. Quick Physical Activities Rating

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

   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.

7. MIND Diet

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

   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.

8. Applied Mindfulness Process Scale

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

   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.

9. ADRD Vulnerability

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

   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.

10. Quick Dementia Rating Scale

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

    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.

11. Number Symbol Coding Task

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

    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.

12. Dementia Screening Platform

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

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

13. Montreal Cognitive Assessment (MoCA)

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

    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.

14. Cognivue Clarity

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

    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.

15. Demographic Information

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

    Updated information on sociodemographic data using UDSv3.0 forms.

16. Medical Evaluation

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

    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".

17. MINT Evaluation

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

    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.

18. Craft Story Evaluation

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

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

19. Benson Copy Evaluation

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

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

20. Category and Letter fluency Evaluation

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

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

21. Number Forward/Backward Evaluation

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

    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.

22. Trailmaking A & B Evaluation

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

    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.

23. Noise Pareidoloia Evaluation

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

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

24. Geriatric Depression Evaluation

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

    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.

25. Functional Activities Questionnaire

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

    Functional Activities Questionnaire to assess activities of daily living.

26. Neuropsychiatric Inventory

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

    Neropsychiatric Inventory to assess behavior.

27. Plasma Amyloid-β42

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

    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.

28. Plasma Amyloid-β40

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

    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.

29. Plasma P-tau181

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

    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.

30. Glial Fibrillary Acidic Protein

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

    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.

31. Neurofilament Light

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

    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.

32. Synuclein

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

    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.

33. Genetics

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

    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)

Results and safety

Results are not available in the source record.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
• Background: PubMed 32280149Tofaeono 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.
• BackgroundWilliams 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
• Individual participant dataSharing planned: Yes. The Multi Principal Investigators are committed to placing its data in the public domain where it will be available to qualified scientific investigators by a defined process and at time intervals, in accordance with NIH policy. The database/registry may be very attractive for the evaluation of potential therapies for age-related diseases. the database will: 1) serve pedagogy (education) functions, 2) facilitate standardized collection and analysis protocols, and 3) promote collaboration among investigators (within and between institutions). We have a web-based resource repository developed and an account at Open Science Framework and upon acceptance of a publication, a de-identified dataset (including any genetic data) with all variables related to that publication will be placed at Open Science Framework and a Digital Object Identifier will be made available in all publications following HIPAA and Institutional Review Board guidelines.

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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.

2 sites in 1 country: see every site and its status.