Alzheimer s DiseaseNCT07917182
Chinese University-Alzheimer's Disease With Vascular and Other Co-pathology: Towards Actionable Neuro-Cognitive-Omic Evaluations (CU-ADVANCE)
An observational study of Alzheimer s Disease and Mild Cognitive Impairment (MCI), run by Chinese University of Hong Kong at 1 site in China.
Trial summary
Population aging is transforming the epidemiological landscape of the Asia-Pacific region at an unprecedented pace. By 2050, more than one quarter of the region's population will be aged over 60, with 36.7% of countries projected to become" super-aged" societies. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer s Disease, Mild Cognitive Impairment (MCI)
- How many people
- 1,600 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2026to 30 Jun 2032
- How long will I take part?
- 6 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be identified from community, existing cohorts and specialist clinics
Who may be able to join
- Aged ≥ 40 years old; and
- Participants must have a study partner (spouse, relative, or other person in regular contact, ≥ 10 hours/week)who is willing and able to accompany participant to relevant visits and provide independent report on cognitive/functional/behavioral status (e.g., cognitive evaluation); and
- Visual and auditory acuity sufficient (with correction/hearing aids as needed) to complete neuropsychological testing as per examiner judgment; and
- A primary language of Cantonese.
Who cannot join
- Clinical diagnosis of a primary neurological disorder that could independently account for cognitive impairment, including but not limited to Huntington's disease, normal pressure hydrocephalus, prion disease (CJD or variants), multiple sclerosis or other demyelinating disease, epilepsy, and/or
- Know history of major depressive episodes, schizophrenia, bipolar disorder, and/or
- Know history of moderate-to-severe traumatic brain injury, brain tumor, and/or
- Contraindication for MRI or PET.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Chinese University of Hong Kong
Hong Kong
Pauline Kwan, Master's Degree, +852 26352160, paulinekwan@cuhk.edu.hk
About this study
Population aging is transforming the epidemiological landscape of the Asia-Pacific region at an unprecedented pace. By 2050, more than one quarter of the region's population will be aged over 60, with 36.7% of countries projected to become" super-aged" societies.
Within Hong Kong specifically, the age- and gender-adjusted prevalence rates of mild and major neurocognitive disorder (NCD) among adults aged 60 years or above have been estimated at 21.8% and 9.7%, respectively. The scale of this burden intensifies considerably within institutional care environments, where roughly seven in ten long-term care (LTC) residents have been identified as having major NCD. Recent local survey data also indicate that severe cognitive impairment affects up to 49.8% of residents aged above 85 years. Given current demographic trajectories, the number of individuals living with dementia in Hong Kong is projected to triple over the next two decades. These trends underscore an urgent, time-sensitive need for scalable, accurate, and population-appropriate tools for the early detection and prognostic stratification of cognitive impairment, tools that must be actionable at the point of care and deployable at population scale.
This study aim to generate a large database of cognitive, neuroimaging, plasma biomarkers, lifestyle and psychological information of the subjects who suffered from neurocognitive disorders
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Unimpaired | Not described | |
| MCI | Subject with mild cognitive impairment, which identified with CDR =0.5 | |
| Dementia | Subject with mild cognitive impairment, which identified with CDR =1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hong Kong Montreal Cognitive Assessment (HK-MoCA)
The HK-MoCA is a locally validated, brief cognitive screening tool assessing multiple domains including attention, executive function, memory, language, visuospatial ability, and orientation, and is widely used to detect mild cognitive impairment in the Hong Kong Chinese population. The total score is 30. The lower the score, the higher risk of cognitive impairment
Measured: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years and 6 years follow up
Clinical Dementia Rating
The CDR is a semi-structured interview-based staging instrument that evaluates both cognitive and functional performance across six domains (memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care), yielding a global score that reflects overall severity of cognitive impairment (0 = normal, 0.5 = questionable/very mild, 1 = mild, 2 = moderate, 3 = severe).
Measured: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years and 6 years follow up
Hong Kong List Learning Test
The HKLLT is a culturally adapted verbal list-learning test modeled after the California Verbal Learning Test, used to assess verbal learning and memory, with Trial 4 (T4, delayed recall) serving as a sensitive index of episodic memory decline. The lower the standard deviation of the Trial 4 recall, the higher the risk of cognitive impairment
Measured: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years and 6 years follow up
Simple Mild Neurocognitive Disorder due to Alzheimer's Disease Risk Test (SMART)
The SMART is a novel digitalised tool that incorporates both subjective and objective measures of cognitive impairment. it incorporates immediate recall, delayed recall, and verbal fluency tasks. The lower the z-score, the higher the risk of cognitive impairment
Measured: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years and 6 years follow up
Secondary outcomes (2)
The pathological findings and changes on PET imaging
An amyloid PET (Positron Emission Tomography) scan measures beta-amyloid plaques in the brain which lead to Alzheimer's disease (AD) pathogenesis. The key quantitative measurements are Standarized uptake value ratio (SUVR) and Centiloid Scale (CL) . The higher the vlaue of SUVR and CL reflect greater amyloid accumulation in the brain.
Measured: baseline and 3 year follow up
The pathological findings and changes on MRI
A MRI brain scan mainly investigate and measure the structure of the brain. Volume of specific brain regions (such as the hippocampus, ventricles, or total gray/white matter) in cubic centimeters (cm³)
Measured: baseline and 3 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start30 Nov 2026 (estimated)
- Primary completion31 Dec 2031 (estimated)
- Study completion30 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Alzheimer s DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,600 participants (estimated)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Owen Ho KO, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917182
- Sponsor's protocol ID
- 2026.605
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Regier DA, Kuhl EA, Kupfer DJ. The DSM-5: Classification and criteria changes. World Psychiatry. 2013 Jun;12(2):92-8. doi: 10.1002/wps.20050.
PubMed 23737408Lam LC, Leung T, Lui VW, Leung VP, Chiu HF. Association between cognitive function, behavioral syndromes and two-year clinical outcome in Chinese subjects with late-onset Alzheimer's disease. Int Psychogeriatr. 2006 Sep;18(3):517-26. doi: 10.1017/S1041610205002930. Epub 2006 Feb 8.
PubMed 16466588Morris 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 8232972Yeung PY, Wong LL, Chan CC, Leung JL, Yung CY. A validation study of the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) in Chinese older adults in Hong Kong. Hong Kong Med J. 2014 Dec;20(6):504-10. doi: 10.12809/hkmj144219. Epub 2014 Aug 15.
PubMed 25125421Lam BYK, Ran AR, Cai Y, Zheng H, Wei J, Ng YT, Chan MYH, Chiu HY, Ko H, Cheung CY, Mok VCT. Deep learning retinal imaging model identifies poor brain health among older adults without dementia. Cereb Circ Cogn Behav. 2026 Jan 16;10:100529. doi: 10.1016/j.cccb.2026.100529. eCollection 2026.
PubMed 41625481Cheung CY, Ran AR, Wang S, Chan VTT, Sham K, Hilal S, Venketasubramanian N, Cheng CY, Sabanayagam C, Tham YC, Schmetterer L, McKay GJ, Williams MA, Wong A, Au LWC, Lu Z, Yam JC, Tham CC, Chen JJ, Dumitrascu OM, Heng PA, Kwok TCY, Mok VCT, Milea D, Chen CL, Wong TY. A deep learning model for detection of Alzheimer's disease based on retinal photographs: a retrospective, multicentre case-control study. Lancet Digit Health. 2022 Nov;4(11):e806-e815. doi: 10.1016/S2589-7500(22)00169-8. Epub 2022 Sep 30.
PubMed 36192349Cai Y, Fan X, Zhao L, Liu W, Luo Y, Lau AYL, Au LWC, Shi L, Lam BYK, Ko H, Mok VCT. Comparing machine learning-derived MRI-based and blood-based neurodegeneration biomarkers in predicting syndromal conversion in early AD. Alzheimers Dement. 2023 Nov;19(11):4987-4998. doi: 10.1002/alz.13083. Epub 2023 Apr 23.
PubMed 37087687Zhao L, Luo Y, Lew D, Liu W, Au L, Mok V, Shi L; Alzheimer Disease Neuroimaging Initiative. Risk estimation before progression to mild cognitive impairment and Alzheimer's disease: an AD resemblance atrophy index. Aging (Albany NY). 2019 Aug 29;11(16):6217-6236. doi: 10.18632/aging.102184. Epub 2019 Aug 29.
PubMed 31467257Cheung CY, Wong WLE, Hilal S, Kan CN, Gyanwali B, Tham YC, Schmetterer L, Xu D, Lee ML, Hsu W, Venketasubramanian N, Tan BY, Wong TY, Chen CPLH. Deep-learning retinal vessel calibre measurements and risk of cognitive decline and dementia. Brain Commun. 2022 Aug 17;4(4):fcac212. doi: 10.1093/braincomms/fcac212. eCollection 2022.
PubMed 36043139Chan VTT, Sun Z, Tang S, Chen LJ, Wong A, Tham CC, Wong TY, Chen C, Ikram MK, Whitson HE, Lad EM, Mok VCT, Cheung CY. Spectral-Domain OCT Measurements in Alzheimer's Disease: A Systematic Review and Meta-analysis. Ophthalmology. 2019 Apr;126(4):497-510. doi: 10.1016/j.ophtha.2018.08.009. Epub 2018 Aug 13.
PubMed 30114417Costanzo E, Lengyel I, Parravano M, Biagini I, Veldsman M, Badhwar A, Betts M, Cherubini A, Llewellyn DJ, Lourida I, MacGillivray T, Rittman T, Tamburin S, Tai XY, Virgili G. Ocular Biomarkers for Alzheimer Disease Dementia: An Umbrella Review of Systematic Reviews and Meta-analyses. JAMA Ophthalmol. 2023 Jan 1;141(1):84-91. doi: 10.1001/jamaophthalmol.2022.4845.
PubMed 36394831Yin X, Zhang S, Lee JH, Dong H, Mourgkos G, Terwilliger G, Kraus A, Geraldo LH, Poulet M, Fischer S, Zhou T, Mohammed FS, Zhou J, Wang Y, Malloy S, Rohner N, Sharma L, Salinas I, Eichmann A, Thomas JL, Saltzman WM, Huttner A, Zeiss C, Ring A, Iwasaki A, Song E. Compartmentalized ocular lymphatic system mediates eye-brain immunity. Nature. 2024 Apr;628(8006):204-211. doi: 10.1038/s41586-024-07130-8. Epub 2024 Feb 28.
PubMed 38418880Duering M, Biessels GJ, Brodtmann A, Chen C, Cordonnier C, de Leeuw FE, Debette S, Frayne R, Jouvent E, Rost NS, Ter Telgte A, Al-Shahi Salman R, Backes WH, Bae HJ, Brown R, Chabriat H, De Luca A, deCarli C, Dewenter A, Doubal FN, Ewers M, Field TS, Ganesh A, Greenberg S, Helmer KG, Hilal S, Jochems ACC, Jokinen H, Kuijf H, Lam BYK, Lebenberg J, MacIntosh BJ, Maillard P, Mok VCT, Pantoni L, Rudilosso S, Satizabal CL, Schirmer MD, Schmidt R, Smith C, Staals J, Thrippleton MJ, van Veluw SJ, Vemuri P, Wang Y, Werring D, Zedde M, Akinyemi RO, Del Brutto OH, Markus HS, Zhu YC, Smith EE, Dichgans M, Wardlaw JM. Neuroimaging standards for research into small vessel disease-advances since 2013. Lancet Neurol. 2023 Jul;22(7):602-618. doi: 10.1016/S1474-4422(23)00131-X. Epub 2023 May 23.
PubMed 37236211Chouliaras L, O'Brien JT. The use of neuroimaging techniques in the early and differential diagnosis of dementia. Mol Psychiatry. 2023 Oct;28(10):4084-4097. doi: 10.1038/s41380-023-02215-8. Epub 2023 Aug 22.
PubMed 37608222Crary JF, Trojanowski JQ, Schneider JA, Abisambra JF, Abner EL, Alafuzoff I, Arnold SE, Attems J, Beach TG, Bigio EH, Cairns NJ, Dickson DW, Gearing M, Grinberg LT, Hof PR, Hyman BT, Jellinger K, Jicha GA, Kovacs GG, Knopman DS, Kofler J, Kukull WA, Mackenzie IR, Masliah E, McKee A, Montine TJ, Murray ME, Neltner JH, Santa-Maria I, Seeley WW, Serrano-Pozo A, Shelanski ML, Stein T, Takao M, Thal DR, Toledo JB, Troncoso JC, Vonsattel JP, White CL 3rd, Wisniewski T, Woltjer RL, Yamada M, Nelson PT. Primary age-related tauopathy (PART): a common pathology associated with human aging. Acta Neuropathol. 2014 Dec;128(6):755-66. doi: 10.1007/s00401-014-1349-0. Epub 2014 Oct 28.
PubMed 25348064
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese University-Alzheimer's Disease With Vascular and Other Co-pathology: Towards Actionable Neuro-Cognitive-Omic Evaluations (CU-ADVANCE)
- ClinicalTrials.gov ID
- NCT07917182
- Acronym / sponsor ID
- 2026.605
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 30 Jun 2032 (estimated)
- First posted
- 4 Nov 2026 (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.
Population aging is transforming the epidemiological landscape of the Asia-Pacific region at an unprecedented pace. By 2050, more than one quarter of the region's population will be aged over 60, with 36.7% of countries projected to become" super-aged" societies.
Within Hong Kong specifically, the age- and gender-adjusted prevalence rates of mild and major neurocognitive disorder (NCD) among adults aged 60 years or above have been estimated at 21.8% and 9.7%, respectively. The scale of this burden intensifies considerably within institutional care environments, where roughly seven in ten long-term care (LTC) residents have been identified as having major NCD. Recent local survey data also indicate that severe cognitive impairment affects up to 49.8% of residents aged above 85 years. Given current demographic trajectories, the number of individuals living with dementia in Hong Kong is projected to triple over the next two decades. These trends underscore an urgent, time-sensitive need for scalable, accurate, and population-appropriate tools for the early detection and prognostic stratification of cognitive impairment, tools that must be actionable at the point of care and deployable at population scale.
This study aim to generate a large database of cognitive, neuroimaging, plasma biomarkers, lifestyle and psychological information of the subjects who suffered from neurocognitive disorders
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive Unimpaired | – | – |
| MCI | – | –Subject with mild cognitive impairment, which identified with CDR =0.5 |
| Dementia | – | –Subject with mild cognitive impairment, which identified with CDR =1 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be identified from community, existing cohorts and specialist clinics
Key inclusion criteria (4 listed)
- Aged ≥ 40 years old; and
- Participants must have a study partner (spouse, relative, or other person in regular contact, ≥ 10 hours/week)who is willing and able to accompany participant to relevant visits and provide independent report on cognitive/functional/behavioral status (e.g., cognitive evaluation); and
- Visual and auditory acuity sufficient (with correction/hearing aids as needed) to complete neuropsychological testing as per examiner judgment; and
- A primary language of Cantonese.
Key exclusion criteria (4 listed)
- Clinical diagnosis of a primary neurological disorder that could independently account for cognitive impairment, including but not limited to Huntington's disease, normal pressure hydrocephalus, prion disease (CJD or variants), multiple sclerosis or other demyelinating disease, epilepsy, and/or
- Know history of major depressive episodes, schizophrenia, bipolar disorder, and/or
- Know history of moderate-to-severe traumatic brain injury, brain tumor, and/or
- Contraindication for MRI or PET.
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
Hong Kong Montreal Cognitive Assessment (HK-MoCA)
Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years and 6 years follow up
The HK-MoCA is a locally validated, brief cognitive screening tool assessing multiple domains including attention, executive function, memory, language, visuospatial ability, and orientation, and is widely used to detect mild cognitive impairment in the Hong Kong Chinese population. The total score is 30. The lower the score, the higher risk of cognitive impairment
Clinical Dementia Rating
Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years and 6 years follow up
The CDR is a semi-structured interview-based staging instrument that evaluates both cognitive and functional performance across six domains (memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care), yielding a global score that reflects overall severity of cognitive impairment (0 = normal, 0.5 = questionable/very mild, 1 = mild, 2 = moderate, 3 = severe).
Hong Kong List Learning Test
Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years and 6 years follow up
The HKLLT is a culturally adapted verbal list-learning test modeled after the California Verbal Learning Test, used to assess verbal learning and memory, with Trial 4 (T4, delayed recall) serving as a sensitive index of episodic memory decline. The lower the standard deviation of the Trial 4 recall, the higher the risk of cognitive impairment
Simple Mild Neurocognitive Disorder due to Alzheimer's Disease Risk Test (SMART)
Time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years and 6 years follow up
The SMART is a novel digitalised tool that incorporates both subjective and objective measures of cognitive impairment. it incorporates immediate recall, delayed recall, and verbal fluency tasks. The lower the z-score, the higher the risk of cognitive impairment
2 secondary outcomes
The pathological findings and changes on PET imaging
Time frame: baseline and 3 year follow up
The pathological findings and changes on MRI
Time frame: baseline and 3 year follow up
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 4 Nov 2026.
- Background: PubMed 23737408Regier DA, Kuhl EA, Kupfer DJ. The DSM-5: Classification and criteria changes. World Psychiatry. 2013 Jun;12(2):92-8. doi: 10.1002/wps.20050.
- Background: PubMed 16466588Lam LC, Leung T, Lui VW, Leung VP, Chiu HF. Association between cognitive function, behavioral syndromes and two-year clinical outcome in Chinese subjects with late-onset Alzheimer's disease. Int Psychogeriatr. 2006 Sep;18(3):517-26. doi: 10.1017/S1041610205002930. Epub 2006 Feb 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 25125421Yeung PY, Wong LL, Chan CC, Leung JL, Yung CY. A validation study of the Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) in Chinese older adults in Hong Kong. Hong Kong Med J. 2014 Dec;20(6):504-10. doi: 10.12809/hkmj144219. Epub 2014 Aug 15.
- Background: PubMed 41625481Lam BYK, Ran AR, Cai Y, Zheng H, Wei J, Ng YT, Chan MYH, Chiu HY, Ko H, Cheung CY, Mok VCT. Deep learning retinal imaging model identifies poor brain health among older adults without dementia. Cereb Circ Cogn Behav. 2026 Jan 16;10:100529. doi: 10.1016/j.cccb.2026.100529. eCollection 2026.
- Background: PubMed 36192349Cheung CY, Ran AR, Wang S, Chan VTT, Sham K, Hilal S, Venketasubramanian N, Cheng CY, Sabanayagam C, Tham YC, Schmetterer L, McKay GJ, Williams MA, Wong A, Au LWC, Lu Z, Yam JC, Tham CC, Chen JJ, Dumitrascu OM, Heng PA, Kwok TCY, Mok VCT, Milea D, Chen CL, Wong TY. A deep learning model for detection of Alzheimer's disease based on retinal photographs: a retrospective, multicentre case-control study. Lancet Digit Health. 2022 Nov;4(11):e806-e815. doi: 10.1016/S2589-7500(22)00169-8. Epub 2022 Sep 30.
- Background: PubMed 37087687Cai Y, Fan X, Zhao L, Liu W, Luo Y, Lau AYL, Au LWC, Shi L, Lam BYK, Ko H, Mok VCT. Comparing machine learning-derived MRI-based and blood-based neurodegeneration biomarkers in predicting syndromal conversion in early AD. Alzheimers Dement. 2023 Nov;19(11):4987-4998. doi: 10.1002/alz.13083. Epub 2023 Apr 23.
- Background: PubMed 31467257Zhao L, Luo Y, Lew D, Liu W, Au L, Mok V, Shi L; Alzheimer Disease Neuroimaging Initiative. Risk estimation before progression to mild cognitive impairment and Alzheimer's disease: an AD resemblance atrophy index. Aging (Albany NY). 2019 Aug 29;11(16):6217-6236. doi: 10.18632/aging.102184. Epub 2019 Aug 29.
- Background: PubMed 36043139Cheung CY, Wong WLE, Hilal S, Kan CN, Gyanwali B, Tham YC, Schmetterer L, Xu D, Lee ML, Hsu W, Venketasubramanian N, Tan BY, Wong TY, Chen CPLH. Deep-learning retinal vessel calibre measurements and risk of cognitive decline and dementia. Brain Commun. 2022 Aug 17;4(4):fcac212. doi: 10.1093/braincomms/fcac212. eCollection 2022.
- Background: PubMed 30114417Chan VTT, Sun Z, Tang S, Chen LJ, Wong A, Tham CC, Wong TY, Chen C, Ikram MK, Whitson HE, Lad EM, Mok VCT, Cheung CY. Spectral-Domain OCT Measurements in Alzheimer's Disease: A Systematic Review and Meta-analysis. Ophthalmology. 2019 Apr;126(4):497-510. doi: 10.1016/j.ophtha.2018.08.009. Epub 2018 Aug 13.
- Background: PubMed 36394831Costanzo E, Lengyel I, Parravano M, Biagini I, Veldsman M, Badhwar A, Betts M, Cherubini A, Llewellyn DJ, Lourida I, MacGillivray T, Rittman T, Tamburin S, Tai XY, Virgili G. Ocular Biomarkers for Alzheimer Disease Dementia: An Umbrella Review of Systematic Reviews and Meta-analyses. JAMA Ophthalmol. 2023 Jan 1;141(1):84-91. doi: 10.1001/jamaophthalmol.2022.4845.
- Background: PubMed 38418880Yin X, Zhang S, Lee JH, Dong H, Mourgkos G, Terwilliger G, Kraus A, Geraldo LH, Poulet M, Fischer S, Zhou T, Mohammed FS, Zhou J, Wang Y, Malloy S, Rohner N, Sharma L, Salinas I, Eichmann A, Thomas JL, Saltzman WM, Huttner A, Zeiss C, Ring A, Iwasaki A, Song E. Compartmentalized ocular lymphatic system mediates eye-brain immunity. Nature. 2024 Apr;628(8006):204-211. doi: 10.1038/s41586-024-07130-8. Epub 2024 Feb 28.
- Global status report on the public health response to dementia.Link provided by the sponsor.
- Biostatistics: a foundation for analysis in the health sciencesLink provided by the sponsor.
- 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.
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 Alzheimer s Disease and Mild Cognitive Impairment (MCI), run by Chinese University of Hong Kong at 1 site in China.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 4 Nov 2026. 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 China. 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 Pauline Kwan, Master's Degree (+852 26352160, paulinekwan@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hong Kong Montreal Cognitive Assessment (HK-MoCA) (time frame: Baseline, 1 year, 2 years, 3 years, 4 years, 5 years and 6 years follow up). The study lists 4 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 NCT07917182, which also lists 39 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 4 Nov 2026.