DementiaINDENCT06375213
Investigating Neurocognitive Disorders Epidemiology
An observational study of Dementia and Cognitive Decline, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
Trial summary
This is a prospective cohort study with the main purpose of predicting progression neurocognitive disorders in Thai population. The main predictor variables to be evaluated are plasma phosphorylated tau (p-tau) level and cognitive test scores, which will be combined using statistical/computational modeling. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Cognitive Decline, Alzheimer Disease
- What is being tested?
- Plasma tau phosphorylated at Thr217 and Neurocognitive examination
- Type of treatment
- Injection or infusion
- How many people
- 990 participants
- Where
- 1 siteThailand
- Study dates
- 24 Aug 2023to 24 Aug 2035
- How long will I take part?
- 8 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The target population of this study comprises individuals with a risk of cognitive decline in Thailand categorized by their cognitive status.
Who may be able to join
- Demonstrate normal cognitive function within the expected range on objective cognitive tests.
- Proficient in speaking and understanding Thai without the need for a translator to participate.
- Display impaired/abnormal performance on objective cognitive tests.
- Does not meet criteria for dementia per NIA-AA (or major neurocognitive disorder per DSM-5).
- Proficient in speaking and understanding Thai without the need for a translator to participate.
- Display impaired/abnormal performance on objective cognitive tests.
Show all 13Show fewer
- Meets criteria for dementia per NIA-AA (or major neurocognitive disorder per DSM-5), including dementia due to Alzheimer's disease or other causes.
- Begins to experience symptoms, identified by the physician as a part of dementia continuum, occurring after the age of 65.
- Proficient in speaking and understanding Thai without the need for a translator to participate.
- Display impaired/abnormal performance on objective cognitive tests.
- Meets criteria for dementia per NIA-AA (or major neurocognitive disorder per DSM-5), including dementia due to Alzheimer's disease or other causes.
- Begins to experience symptoms, identified by the physician as a part of dementia continuum, occurring before the age of 65.
- Proficient in speaking and understanding Thai without the need for a translator to participate.
Who cannot join
- Significant neurological or uncontrolled psychiatric illness.
- Significant unstable systemic condition or end-stage organ failure that affects study participation.
- Mild Cognitive Impairment
- Significant neurological or uncontrolled psychiatric illness.
- Significant unstable systemic condition or end-stage organ failure that affects study participation.
- Late Onset Dementia
Show all 11Show fewer
- Significant neurological or uncontrolled psychiatric illness.
- Significant unstable systemic condition or end-stage organ failure that affects study participation.
- Early Onset Dementia
- Significant neurological or uncontrolled psychiatric illness.
- Significant unstable systemic condition or end-stage organ failure that affects study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thanakit Pongpitakmetha, M.D. contact
Thailand1 site, 1 recruiting
- Recruiting
King Chulalongkorn Memorial Hospital
Pathum Wan, Bangkok, 10330
Adipa Chongsuksantikul, D.Eng., +66 (0)84 1134443, adipar@gmail.com
About this study
This is a prospective cohort study with the main purpose of predicting progression neurocognitive disorders in Thai population. The main predictor variables to be evaluated are plasma phosphorylated tau (p-tau) level and cognitive test scores, which will be combined using statistical/computational modeling. Additionally, it seeks to evaluate biomarkers for diagnosing disease pathologies, understand their correlation with clinical outcomes, and explore the socioeconomic impact of neurocognitive disorders. The study invites both participants for biospecimen collection, structured interviews, and cognitive examinations and schedules follow-up visits annually or biennially.
Read the detailed description
The INDE study is a prospective cohort aimed at investigating the natural history and epidemiology of neurocognitive disorders in Thailand. Its primary objective is to develop a predictive model that combines biomarkers (eg. plasma phosphorylated tau) and cognitive performance to accurately predict cognitive decline. Additional objectives include cross-sectional evaluation of various biomarkers for diagnosing disease pathologies, identifying correlations between biomarkers and clinical outcomes, understanding the impact of receiving a biological diagnosis, describing the epidemiology of neurocognitive disorders including risk factors and social determinants of health (SDH), exploring the socioeconomic consequences of these disorders, and establishing a biorepository for future research. The study invites both healthy volunteers and patients referred from memory clinics to participate in a 4-hour visit during which various research procedures are conducted: collection of biospecimens (blood, saliva, sweat), structured interviews covering symptoms, comorbidities, risk factors, SDH, and quality of life, as well as a comprehensive cognitive examination. Participants are scheduled for annual or biennial follow-up visits based on their cognitive status. For those consenting to specific disclosures, investigators provide some biomarker test results and offer post-test counseling based on available research literature. Depending on current funding, a subset of participants meeting additional criteria may also undergo evaluation using appropriate neuroimaging or cerebrospinal fluid (CSF) biomarkers.
- Conditions
- Dementia, Cognitive Decline, Alzheimer Disease
- Being tested
- Plasma tau phosphorylated at Thr217, Neurocognitive examination
- Medical subject headings
- Dementia, Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma tau phosphorylated at Thr217Diagnostic test
Also called S-PLEX Human Tau (pT217) Kit, ALZpath pTau-217 CARe Advantage Kit
Plasma concentration of tau protein phosphorylated at Thr217 as measured on the Meso Scale Discovery, single molecule array (Simoa) or the in-house mass spectrometry platform.
Neurocognitive examinationOther
Traditional (paper and pencil) neurocognitive/neuropsychiatric examination performed by certified psychologists. This includes: Mini Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Clinical Dementia Rating (CDR), Wechsler Memory Scale - Fourth Edition (WMS-IV), Neuropsychiatric Inventory - Questionnaire (NPI-Q), Thai Geriatric Depression Scale (TGDS), General Anxiety Disorder - 7 (GAD-7), The Barthel activities of daily living (ADL) Index, Chula ADL Index.
| Study group | Role | What they receive |
|---|---|---|
| Cognitively healthy | This cohort includes participants with or without subjective complaints whose results of cognitive examination are normal. Participants will undergo clinical, epidemiological, and cognitive assessments, as well as biospecimen collection every two years, over an 8-year follow-up period. Receives: Diagnostic Test: Plasma tau phosphorylated at Thr217; Other: Neurocognitive examination | |
| Mild cognitive impairment | This cohort includes participants whose results of cognitive examination are abnormal but have not met the criteria for dementia. Participants will undergo annual clinical, epidemiological, and cognitive assessments, as well as biospecimen collection, for a duration of six years. Receives: Diagnostic Test: Plasma tau phosphorylated at Thr217; Other: Neurocognitive examination | |
| Late onset dementia | This cohort includes participants with dementia whose symptoms onset after the age of 65. Participants will undergo annual clinical, epidemiological, and cognitive assessments, as well as biospecimen collection, for a duration of two years. Receives: Diagnostic Test: Plasma tau phosphorylated at Thr217; Other: Neurocognitive examination | |
| Early onset dementia | This cohort includes participants with dementia whose symptoms onset before the age of 65. Participants will undergo annual clinical, epidemiological, and cognitive assessments, as well as biospecimen collection, for a duration of six years. Receives: Diagnostic Test: Plasma tau phosphorylated at Thr217; Other: Neurocognitive examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression to dementia
Fulfilling the criteria for dementia according to the National Institute on Aging and the Alzheimer's Association (NIA-AA) 2018 criteria or major neurocognitive disorder (according to DSM-5) as evaluated by neurologist with special interests in neurocognitive disorders. If such designation is not available, reaching a global CDR score of 1 will be used as a substitute. This outcome only applies to cognitively healthy and mild cognitive impairment cohort.
Measured: At 2, 4, 6 and 8 years
Changes in Sum of Boxes of the Clinical Dementia Rating Scale
Administered by a certified psychologist in accordance with Morris, J.C. (1993).
Minimum value: 0 Maximum value: 18 Higher scores mean a worse outcome.
Measured: At 2, 4, 6 and 8 years
Secondary outcomes (11)
Changes in the Montreal Cognitive Assessment
Administered by a certified psychologist. Minimum value: 0 Maximum value: 30 Higher scores mean a better outcome.
Measured: At 2, 4, 6 and 8 years
Changes in the Montreal Cognitive Assessment - Memory Index Score
Administered by a certified psychologist. Minimum value: 0 Maximum value: 15 Higher scores mean a better outcome.
Measured: At 2, 4, 6 and 8 years
Changes in the Mini Mental State Examination
Administered by a certified psychologist. Minimum value: 0 Maximum value: 30 Higher scores mean a better outcome.
Measured: At 2, 4, 6 and 8 years
Changes in the Wechsler Memory Scale - Fourth Edition (WMS-IV) Visual Reproduction Scaled Score
Administered by a certified psychologist. Minimum value: 1 Maximum value: 19 Higher scores mean a better outcome.
Measured: At 2, 4, 6 and 8 years
Changes in the Wechsler Memory Scale - Fourth Edition (WMS-IV) Logical Memory Scaled Score
Administered by a certified psychologist. Minimum value: 1 Maximum value: 19 Higher scores mean a better outcome.
Measured: At 2, 4, 6 and 8 years
Changes in the Wechsler Memory Scale - Fourth Edition (WMS-IV) Verbal Paired Associates Scaled Score
Administered by a certified psychologist. Minimum value: 1 Maximum value: 19 Higher scores mean a better outcome.
Measured: At 2, 4, 6 and 8 years
Biological diagnosis of Alzheimer's disease
Receiving the diagnosis of Alzheimer's disease based on the abnormality of any pathology-specific biomarkers that fulfills the current NIA-AA criteria. These biomarkers include, but not limited to, amyloid positron emission tomography (PET) (eg. [18 F]-Florbetaben PET), tau-PET (eg. [18F]PI-2620 PET), or CSF levels of core Alzheimer's disease biomarkers.
Measured: within 6 months of baseline measurement
Biological staging of Alzheimer's disease
Staging of Alzheimer's disease based on the abnormality of pathology-specific biomarkers according to the current NIA-AA criteria.
Measured: within 6 months of baseline measurement
Quantitative amyloid PET uptake.
Amyloid PET uptake tracer uptake quantified in Centiloids.
Measured: within 6 months of baseline measurement
Quantitative tau PET uptake in various cortical regions.
Cortical tau-PET uptake measured using mean standardized uptake value ratios of referenced against inferior cerebellar cortex. The pre-specified regions of interest are analogous with Braak staging (as suggested by Cho, H. (2016).):
Stage I-II, entorhinal cortex; Stage III, parahippocampal and fusiform cortices, and amygdala; Stage IV, inferior and middle temporal cortices; Stage V, inferior parietal, posterior cingulate, lingual, orbitofrontal, insular, supramarginal, lateral occipital, superior temporal, precuneus, superior parietal, superior, middle, and inferior frontal, and anterior cingulate cortices; Stage VI, medial occipital, precentral, paracentral, and postcentral cortices.
Measured: within 6 months of baseline measurement
Future diagnosis of Alzheimer's disease dementia.
All of the following:
- Fulfilling the criteria for dementia (NIA-AA 2018) or major neurocognitive disorder (DSM-5) as evaluated by neurologist with special interests in neurocognitive disorders. If such designation is not available, reaching a global CDR score of 1 will be used as a substitute.
- Receiving the diagnosis of Alzheimer's disease based on the abnormality of any pathology-specific biomarkers that fulfills the current NIA-AA criteria. These biomarkers include, but not limited to, amyloid-PET (eg. [18 F]-Florbetaben PET), tau-PET (eg. [18F]PI-2620 PET), or CSF levels of core Alzheimer's disease biomarkers.
- Conclusion made by a neurologist with special interests in neurocognitive disorders that dementia is predominately due to Alzheimer's disease.
Measured: At 2, 4, 6 and 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start24 Aug 2023
- Primary completion24 Aug 2035 (estimated)
- Study completion24 Aug 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- 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
- 990 participants (estimated)
- Target duration
- 8 Years
Sponsor and investigators
- Lead sponsor
- King Chulalongkorn Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Health Systems Research Institute,Thailand
- Responsible party
- Principal investigator, Poosanu Thanapornsangsuth, King Chulalongkorn Memorial Hospital
- Investigators
- Thiravat Hemachudha, M.D., Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375213
- Sponsor's protocol ID
- 425/66
- Acronym
- INDE
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cho H, Choi JY, Hwang MS, Kim YJ, Lee HM, Lee HS, Lee JH, Ryu YH, Lee MS, Lyoo CH. In vivo cortical spreading pattern of tau and amyloid in the Alzheimer disease spectrum. Ann Neurol. 2016 Aug;80(2):247-58. doi: 10.1002/ana.24711. Epub 2016 Jul 8.
PubMed 27323247Morris JC. The Clinical Dementia Rating (CDR): current version and scoring rules. Neurology. 1993 Nov;43(11):2412-4. doi: 10.1212/wnl.43.11.2412-a. No abstract available.
PubMed 8232972Jack CR Jr, Bennett DA, Blennow K, Carrillo MC, Dunn B, Haeberlein SB, Holtzman DM, Jagust W, Jessen F, Karlawish J, Liu E, Molinuevo JL, Montine T, Phelps C, Rankin KP, Rowe CC, Scheltens P, Siemers E, Snyder HM, Sperling R; Contributors. NIA-AA Research Framework: Toward a biological definition of Alzheimer's disease. Alzheimers Dement. 2018 Apr;14(4):535-562. doi: 10.1016/j.jalz.2018.02.018.
PubMed 29653606American Psychiatric Association. Neurocognitive disorders. In Diagnostic and statistical manual of mental disorders (5th ed.). 2013.
Pattanaphesaj J, Thavorncharoensap M, Ramos-Goni JM, Tongsiri S, Ingsrisawang L, Teerawattananon Y. The EQ-5D-5L Valuation study in Thailand. Expert Rev Pharmacoecon Outcomes Res. 2018 Oct;18(5):551-558. doi: 10.1080/14737167.2018.1494574. Epub 2018 Jul 6.
PubMed 29958008
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Neurocognitive Disorders Epidemiology
- ClinicalTrials.gov ID
- NCT06375213
- Acronym / sponsor ID
- INDE / 425/66
- Conditions
- Dementia, Cognitive Decline, Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 990 participants (estimated)
- Lead sponsor
- King Chulalongkorn Memorial HospitalUniversity, hospital or other
- Collaborators
- Health Systems Research Institute,Thailand
- Study start
- 24 Aug 2023 (actual)
- Primary completion
- 24 Aug 2035 (estimated)
- Study completion
- 24 Aug 2035 (estimated)
- First posted
- 19 Apr 2024 (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.
This is a prospective cohort study with the main purpose of predicting progression neurocognitive disorders in Thai population. The main predictor variables to be evaluated are plasma phosphorylated tau (p-tau) level and cognitive test scores, which will be combined using statistical/computational modeling. Additionally, it seeks to evaluate biomarkers for diagnosing disease pathologies, understand their correlation with clinical outcomes, and explore the socioeconomic impact of neurocognitive disorders. The study invites both participants for biospecimen collection, structured interviews, and cognitive examinations and schedules follow-up visits annually or biennially.
Detailed description
The INDE study is a prospective cohort aimed at investigating the natural history and epidemiology of neurocognitive disorders in Thailand. Its primary objective is to develop a predictive model that combines biomarkers (eg. plasma phosphorylated tau) and cognitive performance to accurately predict cognitive decline. Additional objectives include cross-sectional evaluation of various biomarkers for diagnosing disease pathologies, identifying correlations between biomarkers and clinical outcomes, understanding the impact of receiving a biological diagnosis, describing the epidemiology of neurocognitive disorders including risk factors and social determinants of health (SDH), exploring the socioeconomic consequences of these disorders, and establishing a biorepository for future research. The study invites both healthy volunteers and patients referred from memory clinics to participate in a 4-hour visit during which various research procedures are conducted: collection of biospecimens (blood, saliva, sweat), structured interviews covering symptoms, comorbidities, risk factors, SDH, and quality of life, as well as a comprehensive cognitive examination. Participants are scheduled for annual or biennial follow-up visits based on their cognitive status. For those consenting to specific disclosures, investigators provide some biomarker test results and offer post-test counseling based on available research literature. Depending on current funding, a subset of participants meeting additional criteria may also undergo evaluation using appropriate neuroimaging or cerebrospinal fluid (CSF) biomarkers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cognitively healthy | – | Diagnostic Test: Plasma tau phosphorylated at Thr217, Other: Neurocognitive examinationThis cohort includes participants with or without subjective complaints whose results of cognitive examination are normal. Participants will undergo clinical, epidemiological, and cognitive assessments, as well as biospecimen collection every two years, over an 8-year follow-up period. |
| Mild cognitive impairment | – | Diagnostic Test: Plasma tau phosphorylated at Thr217, Other: Neurocognitive examinationThis cohort includes participants whose results of cognitive examination are abnormal but have not met the criteria for dementia. Participants will undergo annual clinical, epidemiological, and cognitive assessments, as well as biospecimen collection, for a duration of six years. |
| Late onset dementia | – | Diagnostic Test: Plasma tau phosphorylated at Thr217, Other: Neurocognitive examinationThis cohort includes participants with dementia whose symptoms onset after the age of 65. Participants will undergo annual clinical, epidemiological, and cognitive assessments, as well as biospecimen collection, for a duration of two years. |
| Early onset dementia | – | Diagnostic Test: Plasma tau phosphorylated at Thr217, Other: Neurocognitive examinationThis cohort includes participants with dementia whose symptoms onset before the age of 65. Participants will undergo annual clinical, epidemiological, and cognitive assessments, as well as biospecimen collection, for a duration of six years. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The target population of this study comprises individuals with a risk of cognitive decline in Thailand categorized by their cognitive status.
Key inclusion criteria (13 listed)
- Display impaired/abnormal performance on objective cognitive tests.
- Meets criteria for dementia per NIA-AA (or major neurocognitive disorder per DSM-5), including dementia due to Alzheimer's disease or other causes.
- Begins to experience symptoms, identified by the physician as a part of dementia continuum, occurring before the age of 65.
- Proficient in speaking and understanding Thai without the need for a translator to participate.
Key exclusion criteria (11 listed)
- Mild Cognitive Impairment
- Late Onset Dementia
- Early Onset Dementia
- Significant neurological or uncontrolled psychiatric illness.
- Significant unstable systemic condition or end-stage organ failure that affects study participation.
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 |
|---|---|---|
| Plasma tau phosphorylated at Thr217Also: S-PLEX Human Tau (pT217) Kit, ALZpath pTau-217 CARe Advantage KitPlasma concentration of tau protein phosphorylated at Thr217 as measured on the Meso Scale Discovery, single molecule array (Simoa) or the in-house mass spectrometry platform. | Diagnostic test | Cognitively healthy, Early onset dementia, Late onset dementia, Mild cognitive impairment |
| Neurocognitive examinationTraditional (paper and pencil) neurocognitive/neuropsychiatric examination performed by certified psychologists. This includes: Mini Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Clinical Dementia Rating (CDR), Wechsler Memory Scale - Fourth Edition (WMS-IV), Neuropsychiatric Inventory - Questionnaire (NPI-Q), Thai Geriatric Depression Scale (TGDS), General Anxiety Disorder - 7 (GAD-7), The Barthel activities of daily living (ADL) Index, Chula ADL Index. | Other | Cognitively healthy, Early onset dementia, Late onset dementia, Mild cognitive impairment |
Primary outcome
Progression to dementia
Time frame: At 2, 4, 6 and 8 years
Fulfilling the criteria for dementia according to the National Institute on Aging and the Alzheimer's Association (NIA-AA) 2018 criteria or major neurocognitive disorder (according to DSM-5) as evaluated by neurologist with special interests in neurocognitive disorders. If such designation is not available, reaching a global CDR score of 1 will be used as a substitute. This outcome only applies to cognitively healthy and mild cognitive impairment cohort.
Changes in Sum of Boxes of the Clinical Dementia Rating Scale
Time frame: At 2, 4, 6 and 8 years
Administered by a certified psychologist in accordance with Morris, J.C. (1993). Minimum value: 0 Maximum value: 18 Higher scores mean a worse outcome.
11 secondary outcomes
Changes in the Montreal Cognitive Assessment
Time frame: At 2, 4, 6 and 8 years
Changes in the Montreal Cognitive Assessment - Memory Index Score
Time frame: At 2, 4, 6 and 8 years
Changes in the Mini Mental State Examination
Time frame: At 2, 4, 6 and 8 years
Changes in the Wechsler Memory Scale - Fourth Edition (WMS-IV) Visual Reproduction Scaled Score
Time frame: At 2, 4, 6 and 8 years
Changes in the Wechsler Memory Scale - Fourth Edition (WMS-IV) Logical Memory Scaled Score
Time frame: At 2, 4, 6 and 8 years
Changes in the Wechsler Memory Scale - Fourth Edition (WMS-IV) Verbal Paired Associates Scaled Score
Time frame: At 2, 4, 6 and 8 years
Biological diagnosis of Alzheimer's disease
Time frame: within 6 months of baseline measurement
Biological staging of Alzheimer's disease
Time frame: within 6 months of baseline measurement
Quantitative amyloid PET uptake.
Time frame: within 6 months of baseline measurement
Quantitative tau PET uptake in various cortical regions.
Time frame: within 6 months of baseline measurement
Future diagnosis of Alzheimer's disease dementia.
Time frame: At 2, 4, 6 and 8 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Background: PubMed 27323247Cho H, Choi JY, Hwang MS, Kim YJ, Lee HM, Lee HS, Lee JH, Ryu YH, Lee MS, Lyoo CH. In vivo cortical spreading pattern of tau and amyloid in the Alzheimer disease spectrum. Ann Neurol. 2016 Aug;80(2):247-58. doi: 10.1002/ana.24711. Epub 2016 Jul 8.
- Background: PubMed 8232972Morris JC. The Clinical Dementia Rating (CDR): current version and scoring rules. Neurology. 1993 Nov;43(11):2412-4. doi: 10.1212/wnl.43.11.2412-a. No abstract available.
- Background: PubMed 29653606Jack CR Jr, Bennett DA, Blennow K, Carrillo MC, Dunn B, Haeberlein SB, Holtzman DM, Jagust W, Jessen F, Karlawish J, Liu E, Molinuevo JL, Montine T, Phelps C, Rankin KP, Rowe CC, Scheltens P, Siemers E, Snyder HM, Sperling R; Contributors. NIA-AA Research Framework: Toward a biological definition of Alzheimer's disease. Alzheimers Dement. 2018 Apr;14(4):535-562. doi: 10.1016/j.jalz.2018.02.018.
- BackgroundAmerican Psychiatric Association. Neurocognitive disorders. In Diagnostic and statistical manual of mental disorders (5th ed.). 2013.
- Background: PubMed 29958008Pattanaphesaj J, Thavorncharoensap M, Ramos-Goni JM, Tongsiri S, Ingsrisawang L, Teerawattananon Y. The EQ-5D-5L Valuation study in Thailand. Expert Rev Pharmacoecon Outcomes Res. 2018 Oct;18(5):551-558. doi: 10.1080/14737167.2018.1494574. Epub 2018 Jul 6.
- Individual participant dataSharing planned: Undecided
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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.
Thanakit Pongpitakmetha, M.D. contact
Thiravat Hemachudha, M.D. principal investigator
Chulalongkorn University
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 Dementia and Cognitive Decline, run by King Chulalongkorn Memorial Hospital at 1 site in Thailand.
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 13 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 22 Apr 2024. 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 Thailand. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Poosanu Thanapornsangsuth, M.D. (+66 (0)2 2564000 ext. 3561, poosanu.t@chula.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression to dementia (time frame: At 2, 4, 6 and 8 years). The study lists 2 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 NCT06375213, which also lists 5 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 22 Apr 2024.