Cognitive Changes Due to Organic Disorder (Finding)SLASNCT03405675
Gerontology Research Programme: The Singapore Longitudinal Ageing Studies (SLAS I & II)
An observational study of Cognitive Changes Due to Organic Disorder (Finding) and Dementia, run by National University of Singapore at 1 site in Singapore.
Trial summary
The Gerontology Research Programme (GRP) in the National University Singapore's Department of Psychological Medicine, was formed to coordinate and facilitate the conduct of multi-disciplinary research on in a wide range of research on ageing and health. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Changes Due to Organic Disorder (Finding), Dementia, Mild Cognitive Impairment
- What is being tested?
- SLAS 1 and SLAS 2
- How many people
- 6,183 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jul 2003to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community-dwelling Elderly (>55 years old) that are able to self-ambulate and who possess sufficient cognitive capacity for participation. Individuals with severe physical or mental disabilities were excluded.
Who may be able to join
- Ability to self-ambulate
- Adequate cognitive capacity for participation
Who cannot join
- Individuals with severe physical or mental disabilities were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gerontology Research Programme: Biological, Clinical, Psychosocial and Behavioural Predictors of Health Status in Prospectively Followed-up Cohorts of Elderly Persons
The Gerontology Research Programme (GRP) in the National University Singapore's Department of Psychological Medicine, was formed to coordinate and facilitate the conduct of multi-disciplinary research on in a wide range of research on ageing and health. The establishment of the Singapore Longitudinal Aging Cohort will provide a large community-based cohort of elderly subjects for observational studies with useful clinical applications. Research synergy is achieved in terms of pooling multi-disciplinary expertise, and combining genetic, biological, environmental, behavioural, social, clinical, and health services approaches to gerontological research.
Read the detailed description
The SLAS is the principal longitudinal cohort study in GRP. The SLAS is a community-based longitudinal epidemiologic study that aims to increase the understanding of ageing and health, and the factors that influence the ageing process. SLAS seeks to identify the cognitive, biomedical, lifestyle and behavioral, as well as psychosocial risk and protective factors that affect the transition from healthy ageing to functional impairment, illness and death.
Participants recruited into SLAS are community-dwelling seniors, aged 55 and above, from various areas in Singapore. Participants are approached door-to-door, are provided detailed information regarding their participation, and are required to provide informed consent before enrollment into the study. The study procedure includes a baseline survey upon enrollment, and participants are revisited on a 3-yearly basis thereafter.
Enrolled subjects provide baseline data through structured interviews, physician assessments, laboratory testing, and self-reports of conditions, symptoms, and risk behaviors. Data in the study is collected by trained research staff and nurses. The information to be collected include:
Outcomes:
Primary Outcomes
4 Main Primary Outcomes
- Mild cognitive impairment and cognitive functioning
- Frailty
- Depression, anxiety (Mood disorder I)
- Successful and healthy ageing
Basic screening followed by diagnostic tests.
Cognitive domain functioning. Particpants are screened fro cogntve impairment using global cognitive tests (MMSE and MOCA). An exhaustive neuropsychological assessment battery is also conducted to assess specific cognitive domain functioning of participants. Selected participants that meet screening criteria, thus indicating the presence of possible cognitive impairment, undergo further testing to determine their cognitive functioning status (cognitively normal, mild cognitive impairment, cognitive decline, or dementia), as diagnosed by a panel of geriatricians, in accordance with the DSM-IV-TR criteria for dementia (1), and the MCI Working Group of the European Consortium on Alzheimer's disease criteria (2).
Frailty assessment. A battery of measures, including self-report, physical assessments and anthropometric measures, is administered to measure the frailty status of the individuals, in accordance with the Fried et al.'s phenotype criteria (3).
Psychiatric assessment. Several self-reported questionnaires are administered to measure the symptomatology of common psychiatric disorders such as depression, among others. Selected participants that meet screening criteria, thus indicating the presence of possible psychiatric disorders, would undergo further testing to determine their mental health state, in accordance with the DSM-IV-TR criteria (1).
Successful and healthy ageing. Successful and healthy ageing is determined by a number of self-reported and objective measurements of health which aim to reflect the overall and physical health, cognitive, emotional and social well-functioning (inclusive of life engagement and life satisfaction) of the individual.
Secondary Outcomes
Physical domain functioning. Self-reported measures as well as physical assessments would be conducted to measure physical functioning, disability and independence in activities of daily living among participants.
Health, health services utilization. Data regarding the history of chronic medical conditions and falls, medication use, use of hospital and primary care services and self-rated health.
Quality of Life. Self-reported measures would be conducted to measure the quality of life amongst the participants.
Mortality. The date of death of participants would be recorded, as well as assessing the Singapore National Registry of Diseases Office (NRDO).
Respiratory functioning. Data regarding respiratory functioning would be collected via a spirometry test.
Risk and protective factors:
Socioeconomic and demographic variables. Information regarding the age, gender, educational status and household income would be collected from the participants via self-report.
Medical history. Information regarding the history of selected medical and mental disorders would be collected from the participants via self-report.
Biological determinants. Biological specimens (blood and urine) will be analyzed for constituents of interest (e.g. micronutrients, lipid and glucose levels, among others).
Pharmacological determinants. The use of pharmacological agents such as anti-inflammatory, cholesterol-lowering and other drugs will be recorded via a self-report measure.
Nutrition. Participants would be assessed on their nutritional status and dietary consumption (NSI screening, MNA screening, food frequency, 2-day food diary). The dietary records are analyzed for nutrients of interest and phytochemicals such as B12, B6, folate, curcumin, and other nutritional supplements.
Lifestyle and health risk behaviors. Lifestyle behaviors measured would include physical, leisure and social activities engagement duration and frequency. Health risk behaviors measured include the body mass index and other anthropometric measures, smoking, customary physical activity, social and productive activities and alcohol use among participants.
Psycho-social data. Self-reported questionnaires are administered to measure life satisfaction, personality, religiosity, social support and asocial network connections for select participants.
- Conditions
- Cognitive Changes Due to Organic Disorder (Finding), Dementia, Mild Cognitive Impairment, Frailty, Depression, Healthy Ageing
- Being tested
- SLAS 1, SLAS 2
- Keywords
- Dementia, Mild cognitive impairment, Cognitive abilities and changes, Functional change and disabilities, Depression, Health and social services utilization, Quality of life, Adverse drug effects, Social network and support, Self-rated health, Medical morbidities, Falls, Health risk behaviors, Nutrition, Apo-E lipoprotein, Phytochemicals, B12, Folate, Homocysteine, Lifestyle
- Medical subject headings
- Signs and Symptoms, Dementia, Cognitive Dysfunction, Frailty, Depression, Drug-Related Side Effects and Adverse Reactions, Health Risk Behaviors, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLAS 1Other
NA. Observational study, no interventions administered.
SLAS 2Other
NA. Observational study, no interventions administered.
| Study group | Role | What they receive |
|---|---|---|
| SLAS 1 | The subjects (N=2800) are recruited from all residents aged 55 years and above in Singapore in the areas covered by the South-East Community Development Council: Geylang, Aljunied, MacPherson, Marine Parade and Bedok (SLAS-I). Receives: Other: SLAS 1 | |
| SLAS 2 | An additional 3200 subjects are recruited from residents in the Bukit Merah and Jurong (SLAS-II). Receives: Other: SLAS 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dementia and Mild Cognitive Impairment (MCI) Subtyping (Clinical diagnosis of different stages of Dementia)
Dementia and MCI is determined by clinical case conference adjudication where geriatric and psychiatric clinicians convene to determine the diagnosis of a case, utilizing the data from (i) Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) (4-5); (ii) Clinical Dementia rating scale: a 5-point scale used to characterize 6 cognitive and functional domain performance: Memory, Orientation, Judgment \& Problem Solving, Community Affairs, Home \& Hobbies, and Personal Care (6). Information to make each rating is obtained through a semi-structured interview of the patient and a reliable informant (e.g. family member). A higher score indicates increased severity of cognitive impairment; (iii) Informant Questionnaire of Cognitive Decline in the Elderly (IQCODE) - reliable informants report on the cognitive state of the participant (7); (iv) a scale on self-reported subjective cognitive difficulties; and (v) a neuropsychological assessment battery (described below).
Measured: 20 years - once every 3-4 years
Global and specific domain cognitive functioning ability (Measuring of Global and Specific domain of Cognitive functions)
MMSE (4) and MoCA (5) - 30 items, total scores range from 0-30, higher scores indicate better cognitive functioning. A cut-off of a score of =<25 is determined as screening positive for cognitive impairment.
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) (8) - measures immediate memory, visuospatial ability, language, attention, delayed memory, and a global cognitive functioning score (a summation of domain scores).
A neurocognitive battery measures immediate and delayed memory/learning, visuospatial ability, language, attention, and executive functioning. All domains are calculated by weighted averages of age and education adjusted scores. Tests: (i) Digit Span forward and backwards tasks (9); (ii) Rey's Auditory Verbal Learning Test (10); (iii) Story Memory Test (11); (iv) Brief Visuospatial Memory Test - Revised (12); (v) Boston Naming Test (13); (vi) Clock Reading Test; (viii) Colour Trials 1 and 2 (14); (ix) Block Design task (9).
Measured: 20 years - once every 3-4 years
Frailty (Measuring the physical and Cognitive Frailty)
Physical frailty was assessed by scores (1 = present, 0 = absent) for five components (shrinking, weakness, slowness, exhaustion, and low Physical Activity (PA)) proposed by Fried et al (3), with the following operational modifications: (i) Shrinking was defined by unintentional weight loss of 4 kg or more in the past 6 months, or BMI less than 18.5 kg/m2, or calf circumference of 31 cm or less. (ii) Weakness was assessed by knee extension strength task in kilogram. (iii) Slowness was assessed by a gait speed test (15). (iv) Exhaustion was measured as a summed score of 3 questions (1-5), "Did you have lots of energy/feel tired (reverse-scored, rs)/worn out (rs)?" (16). A score of <10 was used to denote exhaustion. (v) Low PA was measured by the LASA PA scale, with those falling below the local gender-specific lowest quintile deemed as low PA (17). Participants are categorised by their total scores as robust (score = 0), pre-frail (score = 1-2), and frail (score = 3-5).
Measured: 20 years - once every 3-4 years
Depressive symptoms and diagnosis (Measuring of Depressive symptoms and assessment of stages of Depression)
Depressive symptoms are assessed by the 15-item version of the Geriatric Depression Scale (GDS), with a higher score indicating higher depressivity (18). A cut-off score of 5 is used as indicating the presence of depression. Additionally, participants are formally diagnosed by a medically trained research fellow for common mood-related psychiatric conditions using the Structured Clinical Interview for DSM Disorders (SCID) of DSM IV-TR (1), such as Major Depressive Disorder, Minor Depression, Dysthmic Disorder, Mania/Hypomania disorder, Anxiety and panic disorder, Obsessive-compulsive disorder, Post traumatic stress disorder, Psychotic disorder, Mood disorder due to a General Medical Condition and Alcohol abuse disorders, if they screen as positive for depression on the GDS.
Measured: 20 years - once every 3-4 years
Successful ageing (Measuring the biological, psycho-social and lifestyle factors associated with Successful Ageing)
Successful aging is previously defined (25). Briefly, a score of successful ageing reflects the overall and physical health, cognitive, emotional, social well-functioning, including life engagement \& satisfaction. Physical health and functional well-being was defined as a "good/excellent" self-reported health and IADL independence (20). Cognitive well-functioning and emotional wellbeing was denoted by a minimum MMSE score of 26 (4), and a score below 5 on the GDS (≤5) (18). Social functioning and active engagement in life activities was assessed using a validated questionnaire (26) on participation levels in social, recreational, civic activities, voluntary work, employment/business, and domestic activities. Overall positive life satisfaction was determined using the Life Satisfaction Scale that assessed interest in life, happiness, loneliness, and general ease of living (27). Total summed score ranges from 4 to 18, with the lowest decile indicating a positive life satisfaction.
Measured: 20 years - once every 3-4 years
Secondary outcomes (6)
Self-reported independent functioning (Measuring the BADL and IADL)
Self-reported Independent Functioning is assessed using the Barthel Index (19) and the Lawton and Brody Instrumental Activity of Daily Living Inventory (20), whereby participants report the degree of dependence on others for several daily and instrumental tasks.
Measured: 20 years - once every 3-4 years
Physical performance (Measuring the physical performance tests)
Assessed by the Physical Performance Battery which includes the Performance-Oriented Mobility Assessment-Balance and Gait scales (21-22), with a higher score indicating a higher performance in terms of balance or gait; as well as the amount of force displaced in Newtons on a handgrip and knee extension dynamometer. The scores for each of the tests would be combined into a weighted average that reflects overall physical performance.
Measured: 20 years - once every 3-4 years
Health services utilization (Measuring cost and frequency of health services utilization)
Self-reported frequency of doctor visits over a past 12-month period.
Measured: 20 years - once every 3-4 years
Quality of life (Measuring the Quality of life SF 12)
Assessed by self-reported scales: (i) EQ5D- 3L - a measure of health-related quality of life that comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale (23). (ii) 12-Item Short Form Survey (SF-12) is a 12-item questionnaire used to assess generic health outcomes from the patient's perspective, covering the eight domains of health outcomes: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional \& mental health (24).
Measured: 20 years - once every 3-4 years
Mortality (Measuring the risk factors related to mortality)
Date and cause of death data is collected by computerized record linkage with the National Death Registry through the Singapore National Registry of Diseases Office (NRDO).
Measured: 20 years
Post-bronchodilation spirometry (Measuring the lung functions tests)
A measurement of lung function which yields the (i) Forced vital capacity - the determination of the vital capacity from a maximally forced expiratory effort; (ii) the FEV1 - volume that has been exhaled at the end of the first second of forced expiration; and the (iii) Peak expiratory flow: The highest forced expiratory flow measured with a peak flow meter. Measurements are made following American Thoracic Society (ATS) criteria for spirometric standardization and procedures, based on the best of four readings, with less than 5% variation in the two best readings. FEV1 is expressed as the percentage of predicted from local norms.
Measured: 20 years - once every 3-4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start1 Jul 2003
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Cognitive Changes Due to Organic Disorder (Finding)Studies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,183 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Tan Tock Seng Hospital, Ng Teng Fong General Hospital, St Luke's Hospital, Singapore, St. Paul's Hospital, Canada, Singapore Institute of Technology, Duke-NUS Graduate Medical School, Melbourne Health, University of California, University Hospital, Basel, Switzerland, Université de Sherbrooke, University Hospital Tuebingen, National University Hospital, Singapore, Khoo Teck Puat Hospital, Shanghai Jiao Tong University School of Medicine, University of British Columbia
- Responsible party
- Principal investigator, A/Prof Ng Tze Pin, National University of Singapore
- Investigators
- Tze Pin Ng, PhD, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405675
- Sponsor's protocol ID
- NUS-IRB 04-140
- Acronym
- SLAS
- Status last verified
- Mar 2019
- First submitted
- 26 Oct 2017
- Last updated
- 14 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
American Psychiatric Association. Diagnostic and statistical manual of Mental Disorders, (4th ed., text rev.; DSM-IV-TR). American Psychiatric Association, Washington. 2000.
Portet F, Ousset PJ, Visser PJ, Frisoni GB, Nobili F, Scheltens P, Vellas B, Touchon J; MCI Working Group of the European Consortium on Alzheimer's Disease (EADC). Mild cognitive impairment (MCI) in medical practice: a critical review of the concept and new diagnostic procedure. Report of the MCI Working Group of the European Consortium on Alzheimer's Disease. J Neurol Neurosurg Psychiatry. 2006 Jun;77(6):714-8. doi: 10.1136/jnnp.2005.085332. Epub 2006 Mar 20.
PubMed 16549412Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
PubMed 11253156Folstein MF, Folstein SE, McHugh PR, Fanjiang G. Mini-Mental State Examination: MMSE user's guide. Psychology Assessment Resources; 2000.
Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
PubMed 15817019O'Bryant SE, Waring SC, Cullum CM, Hall J, Lacritz L, Massman PJ, Lupo PJ, Reisch JS, Doody R; Texas Alzheimer's Research Consortium. Staging dementia using Clinical Dementia Rating Scale Sum of Boxes scores: a Texas Alzheimer's research consortium study. Arch Neurol. 2008 Aug;65(8):1091-5. doi: 10.1001/archneur.65.8.1091.
PubMed 18695059Jorm AF. A short form of the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE): development and cross-validation. Psychol Med. 1994 Feb;24(1):145-53. doi: 10.1017/s003329170002691x.
PubMed 8208879Randolph C, Tierney MC, Mohr E, Chase TN. The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): preliminary clinical validity. J Clin Exp Neuropsychol. 1998 Jun;20(3):310-9. doi: 10.1076/jcen.20.3.310.823.
PubMed 9845158Wechsler D. Wechsler adult intelligence scale-fourth. San Antonio, TX: The Psychological Corporation Google Scholar; 2008.
Rey A. L'examen psychologique dans les cas d'encéphalopathie traumatique.(Les problems.). Archives de psychologie (1941).
Yeo D, Gabriel C, Chen C, Lee S, Loenneker T, Wong M. Pilot validation of a customized neuropsychological battery in elderly Singaporeans. Neurol J South East Asia 1997 2(123).
Benedict RHB. Brief visuospatial memory test - revised: Professional manual. Lutz, FL: Psychological Assessment Resources, Inc; 1997.
Kaplan E, Goodglass H, Weintraub S. Boston naming test. Pro-ed; 2001.
D'Elia LF, Satz P, Uchiyama CL, White T. Color Trails Test: Professional Manual. Odessa (Florida): Psychological Assessment Resources; 1996.
Kluger A, Gianutsos JG, Golomb J, Wagner A Jr, Wagner D, Scheurich S. Clinical features of MCI: motor changes. Int Psychogeriatr. 2008 Feb;20(1):32-9. doi: 10.1017/S1041610207006461.
PubMed 18072982
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gerontology Research Programme: Biological, Clinical, Psychosocial and Behavioural Predictors of Health Status in Prospectively Followed-up Cohorts of Elderly Persons
- ClinicalTrials.gov ID
- NCT03405675
- Acronym / sponsor ID
- SLAS / NUS-IRB 04-140
- Conditions
- Cognitive Changes Due to Organic Disorder (Finding), Dementia, Mild Cognitive Impairment, Frailty, Depression, Healthy Ageing
- Keywords
- Dementia, Mild cognitive impairment, Cognitive abilities and changes, Functional change and disabilities, Depression, Health and social services utilization, Quality of life, Adverse drug effects
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,183 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Tan Tock Seng Hospital, Ng Teng Fong General Hospital, St Luke's Hospital, Singapore, St. Paul's Hospital, Canada, Singapore Institute of Technology, Duke-NUS Graduate Medical School, Melbourne Health, University of California, University Hospital, Basel, Switzerland, Université de Sherbrooke, University Hospital Tuebingen, National University Hospital, Singapore, Khoo Teck Puat Hospital, Shanghai Jiao Tong University School of Medicine, University of British Columbia
- Study start
- 1 Jul 2003 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 23 Jan 2018 (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.
The Gerontology Research Programme (GRP) in the National University Singapore's Department of Psychological Medicine, was formed to coordinate and facilitate the conduct of multi-disciplinary research on in a wide range of research on ageing and health. The establishment of the Singapore Longitudinal Aging Cohort will provide a large community-based cohort of elderly subjects for observational studies with useful clinical applications. Research synergy is achieved in terms of pooling multi-disciplinary expertise, and combining genetic, biological, environmental, behavioural, social, clinical, and health services approaches to gerontological research.
Detailed description
The SLAS is the principal longitudinal cohort study in GRP. The SLAS is a community-based longitudinal epidemiologic study that aims to increase the understanding of ageing and health, and the factors that influence the ageing process. SLAS seeks to identify the cognitive, biomedical, lifestyle and behavioral, as well as psychosocial risk and protective factors that affect the transition from healthy ageing to functional impairment, illness and death.
Participants recruited into SLAS are community-dwelling seniors, aged 55 and above, from various areas in Singapore. Participants are approached door-to-door, are provided detailed information regarding their participation, and are required to provide informed consent before enrollment into the study. The study procedure includes a baseline survey upon enrollment, and participants are revisited on a 3-yearly basis thereafter.
Enrolled subjects provide baseline data through structured interviews, physician assessments, laboratory testing, and self-reports of conditions, symptoms, and risk behaviors. Data in the study is collected by trained research staff and nurses. The information to be collected include:
Outcomes:
Primary Outcomes
4 Main Primary Outcomes
- Mild cognitive impairment and cognitive functioning
- Frailty
- Depression, anxiety (Mood disorder I)
- Successful and healthy ageing
Basic screening followed by diagnostic tests.
Cognitive domain functioning. Particpants are screened fro cogntve impairment using global cognitive tests (MMSE and MOCA). An exhaustive neuropsychological assessment battery is also conducted to assess specific cognitive domain functioning of participants. Selected participants that meet screening criteria, thus indicating the presence of possible cognitive impairment, undergo further testing to determine their cognitive functioning status (cognitively normal, mild cognitive impairment, cognitive decline, or dementia), as diagnosed by a panel of geriatricians, in accordance with the DSM-IV-TR criteria for dementia (1), and the MCI Working Group of the European Consortium on Alzheimer's disease criteria (2).
Frailty assessment. A battery of measures, including self-report, physical assessments and anthropometric measures, is administered to measure the frailty status of the individuals, in accordance with the Fried et al.'s phenotype criteria (3).
Psychiatric assessment. Several self-reported questionnaires are administered to measure the symptomatology of common psychiatric disorders such as depression, among others. Selected participants that meet screening criteria, thus indicating the presence of possible psychiatric disorders, would undergo further testing to determine their mental health state, in accordance with the DSM-IV-TR criteria (1).
Successful and healthy ageing. Successful and healthy ageing is determined by a number of self-reported and objective measurements of health which aim to reflect the overall and physical health, cognitive, emotional and social well-functioning (inclusive of life engagement and life satisfaction) of the individual.
Secondary Outcomes
Physical domain functioning. Self-reported measures as well as physical assessments would be conducted to measure physical functioning, disability and independence in activities of daily living among participants.
Health, health services utilization. Data regarding the history of chronic medical conditions and falls, medication use, use of hospital and primary care services and self-rated health.
Quality of Life. Self-reported measures would be conducted to measure the quality of life amongst the participants.
Mortality. The date of death of participants would be recorded, as well as assessing the Singapore National Registry of Diseases Office (NRDO).
Respiratory functioning. Data regarding respiratory functioning would be collected via a spirometry test.
Risk and protective factors:
Socioeconomic and demographic variables. Information regarding the age, gender, educational status and household income would be collected from the participants via self-report.
Medical history. Information regarding the history of selected medical and mental disorders would be collected from the participants via self-report.
Biological determinants. Biological specimens (blood and urine) will be analyzed for constituents of interest (e.g. micronutrients, lipid and glucose levels, among others).
Pharmacological determinants. The use of pharmacological agents such as anti-inflammatory, cholesterol-lowering and other drugs will be recorded via a self-report measure.
Nutrition. Participants would be assessed on their nutritional status and dietary consumption (NSI screening, MNA screening, food frequency, 2-day food diary). The dietary records are analyzed for nutrients of interest and phytochemicals such as B12, B6, folate, curcumin, and other nutritional supplements.
Lifestyle and health risk behaviors. Lifestyle behaviors measured would include physical, leisure and social activities engagement duration and frequency. Health risk behaviors measured include the body mass index and other anthropometric measures, smoking, customary physical activity, social and productive activities and alcohol use among participants.
Psycho-social data. Self-reported questionnaires are administered to measure life satisfaction, personality, religiosity, social support and asocial network connections for select participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLAS 1 | – | Other: SLAS 1The subjects (N=2800) are recruited from all residents aged 55 years and above in Singapore in the areas covered by the South-East Community Development Council: Geylang, Aljunied, MacPherson, Marine Parade and Bedok (SLAS-I). |
| SLAS 2 | – | Other: SLAS 2An additional 3200 subjects are recruited from residents in the Bukit Merah and Jurong (SLAS-II). |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community-dwelling Elderly (>55 years old) that are able to self-ambulate and who possess sufficient cognitive capacity for participation. Individuals with severe physical or mental disabilities were excluded.
Key inclusion criteria (2 listed)
- Ability to self-ambulate
- Adequate cognitive capacity for participation
Key exclusion criteria (1 listed)
- Individuals with severe physical or mental disabilities were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SLAS 1NA. Observational study, no interventions administered. | Other | SLAS 1 |
| SLAS 2NA. Observational study, no interventions administered. | Other | SLAS 2 |
Primary outcome
Dementia and Mild Cognitive Impairment (MCI) Subtyping (Clinical diagnosis of different stages of Dementia)
Time frame: 20 years - once every 3-4 years
Dementia and MCI is determined by clinical case conference adjudication where geriatric and psychiatric clinicians convene to determine the diagnosis of a case, utilizing the data from (i) Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA) (4-5); (ii) Clinical Dementia rating scale: a 5-point scale used to characterize 6 cognitive and functional domain performance: Memory, Orientation, Judgment \& Problem Solving, Community Affairs, Home \& Hobbies, and Personal Care (6). Information to make each rating is obtained through a semi-structured interview of the patient and a reliable informant (e.g. family member). A higher score indicates increased severity of cognitive impairment; (iii) Informant Questionnaire of Cognitive Decline in the Elderly (IQCODE) - reliable informants report on the cognitive state of the participant (7); (iv) a scale on self-reported subjective cognitive difficulties; and (v) a neuropsychological assessment battery (described below).
Global and specific domain cognitive functioning ability (Measuring of Global and Specific domain of Cognitive functions)
Time frame: 20 years - once every 3-4 years
MMSE (4) and MoCA (5) - 30 items, total scores range from 0-30, higher scores indicate better cognitive functioning. A cut-off of a score of =<25 is determined as screening positive for cognitive impairment. Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) (8) - measures immediate memory, visuospatial ability, language, attention, delayed memory, and a global cognitive functioning score (a summation of domain scores). A neurocognitive battery measures immediate and delayed memory/learning, visuospatial ability, language, attention, and executive functioning. All domains are calculated by weighted averages of age and education adjusted scores. Tests: (i) Digit Span forward and backwards tasks (9); (ii) Rey's Auditory Verbal Learning Test (10); (iii) Story Memory Test (11); (iv) Brief Visuospatial Memory Test - Revised (12); (v) Boston Naming Test (13); (vi) Clock Reading Test; (viii) Colour Trials 1 and 2 (14); (ix) Block Design task (9).
Frailty (Measuring the physical and Cognitive Frailty)
Time frame: 20 years - once every 3-4 years
Physical frailty was assessed by scores (1 = present, 0 = absent) for five components (shrinking, weakness, slowness, exhaustion, and low Physical Activity (PA)) proposed by Fried et al (3), with the following operational modifications: (i) Shrinking was defined by unintentional weight loss of 4 kg or more in the past 6 months, or BMI less than 18.5 kg/m2, or calf circumference of 31 cm or less. (ii) Weakness was assessed by knee extension strength task in kilogram. (iii) Slowness was assessed by a gait speed test (15). (iv) Exhaustion was measured as a summed score of 3 questions (1-5), "Did you have lots of energy/feel tired (reverse-scored, rs)/worn out (rs)?" (16). A score of <10 was used to denote exhaustion. (v) Low PA was measured by the LASA PA scale, with those falling below the local gender-specific lowest quintile deemed as low PA (17). Participants are categorised by their total scores as robust (score = 0), pre-frail (score = 1-2), and frail (score = 3-5).
Depressive symptoms and diagnosis (Measuring of Depressive symptoms and assessment of stages of Depression)
Time frame: 20 years - once every 3-4 years
Depressive symptoms are assessed by the 15-item version of the Geriatric Depression Scale (GDS), with a higher score indicating higher depressivity (18). A cut-off score of 5 is used as indicating the presence of depression. Additionally, participants are formally diagnosed by a medically trained research fellow for common mood-related psychiatric conditions using the Structured Clinical Interview for DSM Disorders (SCID) of DSM IV-TR (1), such as Major Depressive Disorder, Minor Depression, Dysthmic Disorder, Mania/Hypomania disorder, Anxiety and panic disorder, Obsessive-compulsive disorder, Post traumatic stress disorder, Psychotic disorder, Mood disorder due to a General Medical Condition and Alcohol abuse disorders, if they screen as positive for depression on the GDS.
Successful ageing (Measuring the biological, psycho-social and lifestyle factors associated with Successful Ageing)
Time frame: 20 years - once every 3-4 years
Successful aging is previously defined (25). Briefly, a score of successful ageing reflects the overall and physical health, cognitive, emotional, social well-functioning, including life engagement \& satisfaction. Physical health and functional well-being was defined as a "good/excellent" self-reported health and IADL independence (20). Cognitive well-functioning and emotional wellbeing was denoted by a minimum MMSE score of 26 (4), and a score below 5 on the GDS (≤5) (18). Social functioning and active engagement in life activities was assessed using a validated questionnaire (26) on participation levels in social, recreational, civic activities, voluntary work, employment/business, and domestic activities. Overall positive life satisfaction was determined using the Life Satisfaction Scale that assessed interest in life, happiness, loneliness, and general ease of living (27). Total summed score ranges from 4 to 18, with the lowest decile indicating a positive life satisfaction.
6 secondary outcomes
Self-reported independent functioning (Measuring the BADL and IADL)
Time frame: 20 years - once every 3-4 years
Physical performance (Measuring the physical performance tests)
Time frame: 20 years - once every 3-4 years
Health services utilization (Measuring cost and frequency of health services utilization)
Time frame: 20 years - once every 3-4 years
Quality of life (Measuring the Quality of life SF 12)
Time frame: 20 years - once every 3-4 years
Mortality (Measuring the risk factors related to mortality)
Time frame: 20 years
Post-bronchodilation spirometry (Measuring the lung functions tests)
Time frame: 20 years - once every 3-4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- BackgroundAmerican Psychiatric Association. Diagnostic and statistical manual of Mental Disorders, (4th ed., text rev.; DSM-IV-TR). American Psychiatric Association, Washington. 2000.
- Background: PubMed 16549412Portet F, Ousset PJ, Visser PJ, Frisoni GB, Nobili F, Scheltens P, Vellas B, Touchon J; MCI Working Group of the European Consortium on Alzheimer's Disease (EADC). Mild cognitive impairment (MCI) in medical practice: a critical review of the concept and new diagnostic procedure. Report of the MCI Working Group of the European Consortium on Alzheimer's Disease. J Neurol Neurosurg Psychiatry. 2006 Jun;77(6):714-8. doi: 10.1136/jnnp.2005.085332. Epub 2006 Mar 20.
- Background: PubMed 11253156Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
- BackgroundFolstein MF, Folstein SE, McHugh PR, Fanjiang G. Mini-Mental State Examination: MMSE user's guide. Psychology Assessment Resources; 2000.
- Background: PubMed 15817019Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
- Background: PubMed 18695059O'Bryant SE, Waring SC, Cullum CM, Hall J, Lacritz L, Massman PJ, Lupo PJ, Reisch JS, Doody R; Texas Alzheimer's Research Consortium. Staging dementia using Clinical Dementia Rating Scale Sum of Boxes scores: a Texas Alzheimer's research consortium study. Arch Neurol. 2008 Aug;65(8):1091-5. doi: 10.1001/archneur.65.8.1091.
- Background: PubMed 8208879Jorm AF. A short form of the Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE): development and cross-validation. Psychol Med. 1994 Feb;24(1):145-53. doi: 10.1017/s003329170002691x.
- Background: PubMed 9845158Randolph C, Tierney MC, Mohr E, Chase TN. The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): preliminary clinical validity. J Clin Exp Neuropsychol. 1998 Jun;20(3):310-9. doi: 10.1076/jcen.20.3.310.823.
- BackgroundWechsler D. Wechsler adult intelligence scale-fourth. San Antonio, TX: The Psychological Corporation Google Scholar; 2008.
- BackgroundRey A. L'examen psychologique dans les cas d'encéphalopathie traumatique.(Les problems.). Archives de psychologie (1941).
- BackgroundYeo D, Gabriel C, Chen C, Lee S, Loenneker T, Wong M. Pilot validation of a customized neuropsychological battery in elderly Singaporeans. Neurol J South East Asia 1997 2(123).
- BackgroundBenedict RHB. Brief visuospatial memory test - revised: Professional manual. Lutz, FL: Psychological Assessment Resources, Inc; 1997.
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.
Tze Pin Ng, PhD principal investigator
National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Changes Due to Organic Disorder (Finding) and Dementia, run by National University of Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dementia and Mild Cognitive Impairment (MCI) Subtyping (Clinical diagnosis of different stages of Dementia) (time frame: 20 years - once every 3-4 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03405675, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2019.