Cerebral Small Vessel DiseasesDREAM-10NCT06164262
Dementia Risk Registry Across the Multidimensional Lifespan: A 10-Year Study
An observational study of Cerebral Small Vessel Diseases and Dementia, Mixed, run by Zhejiang Provincial People's Hospital at 1 site in China.
Trial summary
Age-related cerebral small-vessel disease (CSVD) is a major cause of dementia, predominantly affecting individuals over 60 years of age, with a prevalence exceeding 70% in the elderly population. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Cerebral Small Vessel Diseases, Dementia, Mixed, Health Behavior
- What is being tested?
- Individuals with CSVD
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 1 Dec 2034
- How long will I take part?
- 10 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 30 to 85 years
- All sexes
- Adult, Older adult
Study population: The research population for this study consists of patients who have been diagnosed with Cerebral Small Vessel Disease. The inclusion criteria are: Patients with any of the CSVD-related MRI imaging markers, including recent small subcortical infarcts, lacunes, white matter hyperintensities, perivascular spaces, microbleeds, and superficial cortical siderosis; Patients aged from 30 to 60 years; Sign informed consent. The exclusion criteria are: Unable to cooperate with inspectors; Known dementia; Serious systemic illness, such as heart, liver, kidney disease or major mental illness; Contraindications for imaging examination. The exit criteria are: not meet the inclusion criteria; For any poor adherence, not comply with the requirements of the follow-up, or safety reasons determined by investigator; Any adverse or serious adverse events during the study period judged by investigator. The patients will be recruited from Zhejiang Provincial People's Hospital in the city of Hangzhou.
Who may be able to join
- Patients with any of the CSVD-related MRI imaging markers, including recent small subcortical infarcts, lacunes, white matter hyperintensities, perivascular spaces, microbleeds, and superficial cortical siderosis.
- Patients aged from 30 to 60 years.
- Sign informed consent.
Who cannot join
- Unable to cooperate with inspectors.
- Known dementia.
- Other cognitive diseases (such as Alzheimer's disease, Parkinson's disease, or thyroid disease).
- Serious systemic illness, such as heart, liver, kidney disease or major mental illness.
- Contraindications for imaging examination.
- Exit Criteria:
Show all 9Show fewer
- Not meet the inclusion criteria.
- For any poor adherence, not comply with the requirements of the follow-up, or safety reasons determined by investigator.
- Any adverse or serious adverse events during the study period judged by investigator.
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, 1 recruiting
- Recruiting
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310000
Sheng Zhang, M.D., +8618758188313, zhangsheng@hmc.edu.cn
Sheng Zhang, M.D.
About this study
Official title: Dementia Risk Registry Across the Multidimensional Lifespan: A 10-Year Study（DREAM-10）
Age-related cerebral small-vessel disease (CSVD) is a major cause of dementia, predominantly affecting individuals over 60 years of age, with a prevalence exceeding 70% in the elderly population. However, the correlation between the burden of CSVD and the progression of cognitive impairment in young and middle-aged individuals remains uncertain. DREAM-10 is an observational, prospective study that enrolled individuals aged 30-60 years, who were free from known dementia but exhibited imaging markers related to CSVD. Through prospective registration and follow-up, this study will collect data on patients with CSVD, including clinical information, neuropsychological assessments, multimodal Magnetic Resonance Images (MRI) and retinopathy characterized by Optical Coherence Tomography Angiography (OCTA). CSVD related features seen on neuroimaging include recent small subcortical infarcts, lacunes, white matter hyperintensities, perivascular spaces, microbleeds, brain atrophy, cortical superficial siderosis. Utilizing this data, the researchers aim to investigate the potential dementia risk among young and middle-aged individuals with CSVD over the forthcoming decade, along with identifying its predictive factors.
- Being tested
- Individuals with CSVD
- Keywords
- Cerebral Small Vessel Diseases, Dementia, Cardiovascular health
- Medical subject headings
- Cerebral Small Vessel Diseases, Mixed Dementias, Health Behavior, Health Risk Behaviors, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individuals with CSVDOther
This does not entail the application of interventions.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with CSVD | This does not entail the application of interventions. Receives: Other: Individuals with CSVD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-mental State Examination (MMSE) score
To assess changes in cognitive function of patients. Adopt education level adjustment value (illiteracy, primary school, middle school, university respectively adopt ≤22points, ≤23 points, ≤24 points, ≤26 points) to define dementia.
Measured: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.
Secondary outcomes (8)
The development of total brain small vessel disease burden in MRI
Total brain small-vessel disease burden is used to assess the overall impact of CSVD, with a score range of 0-4 points.
Measured: Baseline ,6-month, and every 1 year, follow-up time up to 10 years.
Blood flow density
Record blood flow density (%) of OCTA.
Measured: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.
Vascular perfusion area
Record vascular perfusion area (mm^2) of OCTA.
Measured: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.
Macular fovea retinal thickness
Record macular fovea retinal thickness (μm) of OCTA.
Measured: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.
Retinal nerve fiber layer thickness
Record retinal nerve fiber layer thickness (μm) of OCTA.
Measured: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.
Resting state functional connectivity changes
The study uses Resting state functional MRI (Rs-fMRI) to measure changes of functional connectivity across regions.
Measured: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.
White matter Integrity
The study uses Diffusion Tensor Imaging (DTI) to obtain FA and MD values, which are used to measure changes in the integrity of white matter.
Measured: Baseline ,6-month, and every 1 year, follow-up time up to 10 years.
Number of Patients with cerebrovascular events, cardiovascular events, or death
Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA) and cerebral hemorrhage. Cardiovascular events included angina and myocardial infarction. Death included any reason caused death.
Measured: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start1 Jan 2024
- Primary completion1 Aug 2034 (estimated)
- Study completion1 Dec 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral Small Vessel DiseasesStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164262
- Sponsor's protocol ID
- KY2023054
- Acronym
- DREAM-10
- Status last verified
- Sep 2026
- First submitted
- 24 Nov 2023
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Duering 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 37236211Lloyd-Jones DM, Allen NB, Anderson CAM, Black T, Brewer LC, Foraker RE, Grandner MA, Lavretsky H, Perak AM, Sharma G, Rosamond W; American Heart Association. Life's Essential 8: Updating and Enhancing the American Heart Association's Construct of Cardiovascular Health: A Presidential Advisory From the American Heart Association. Circulation. 2022 Aug 2;146(5):e18-e43. doi: 10.1161/CIR.0000000000001078. Epub 2022 Jun 29.
PubMed 35766027
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dementia Risk Registry Across the Multidimensional Lifespan: A 10-Year Study（DREAM-10）
- ClinicalTrials.gov ID
- NCT06164262
- Acronym / sponsor ID
- DREAM-10 / KY2023054
- Keywords
- Cerebral Small Vessel Diseases, Dementia, Cardiovascular health
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Zhejiang Provincial People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Aug 2034 (estimated)
- Study completion
- 1 Dec 2034 (estimated)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Age-related cerebral small-vessel disease (CSVD) is a major cause of dementia, predominantly affecting individuals over 60 years of age, with a prevalence exceeding 70% in the elderly population. However, the correlation between the burden of CSVD and the progression of cognitive impairment in young and middle-aged individuals remains uncertain. DREAM-10 is an observational, prospective study that enrolled individuals aged 30-60 years, who were free from known dementia but exhibited imaging markers related to CSVD. Through prospective registration and follow-up, this study will collect data on patients with CSVD, including clinical information, neuropsychological assessments, multimodal Magnetic Resonance Images (MRI) and retinopathy characterized by Optical Coherence Tomography Angiography (OCTA). CSVD related features seen on neuroimaging include recent small subcortical infarcts, lacunes, white matter hyperintensities, perivascular spaces, microbleeds, brain atrophy, cortical superficial siderosis. Utilizing this data, the researchers aim to investigate the potential dementia risk among young and middle-aged individuals with CSVD over the forthcoming decade, along with identifying its predictive factors.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with CSVD | – | Other: Individuals with CSVDThis does not entail the application of interventions. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The research population for this study consists of patients who have been diagnosed with Cerebral Small Vessel Disease. The inclusion criteria are: Patients with any of the CSVD-related MRI imaging markers, including recent small subcortical infarcts, lacunes, white matter hyperintensities, perivascular spaces, microbleeds, and superficial cortical siderosis; Patients aged from 30 to 60 years; Sign informed consent. The exclusion criteria are: Unable to cooperate with inspectors; Known dementia; Serious systemic illness, such as heart, liver, kidney disease or major mental illness; Contraindications for imaging examination. The exit criteria are: not meet the inclusion criteria; For any poor adherence, not comply with the requirements of the follow-up, or safety reasons determined by investigator; Any adverse or serious adverse events during the study period judged by investigator. The patients will be recruited from Zhejiang Provincial People's Hospital in the city of Hangzhou.
Key inclusion criteria (3 listed)
- Patients with any of the CSVD-related MRI imaging markers, including recent small subcortical infarcts, lacunes, white matter hyperintensities, perivascular spaces, microbleeds, and superficial cortical siderosis.
- Patients aged from 30 to 60 years.
- Sign informed consent.
Key exclusion criteria (9 listed)
- Unable to cooperate with inspectors.
- Known dementia.
- Other cognitive diseases (such as Alzheimer's disease, Parkinson's disease, or thyroid disease).
- Serious systemic illness, such as heart, liver, kidney disease or major mental illness.
- Contraindications for imaging examination.
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 |
|---|---|---|
| Individuals with CSVDThis does not entail the application of interventions. | Other | Individuals with CSVD |
Primary outcome
Mini-mental State Examination (MMSE) score
Time frame: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.
To assess changes in cognitive function of patients. Adopt education level adjustment value (illiteracy, primary school, middle school, university respectively adopt ≤22points, ≤23 points, ≤24 points, ≤26 points) to define dementia.
8 secondary outcomes
The development of total brain small vessel disease burden in MRI
Time frame: Baseline ,6-month, and every 1 year, follow-up time up to 10 years.
Blood flow density
Time frame: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.
Vascular perfusion area
Time frame: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.
Macular fovea retinal thickness
Time frame: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.
Retinal nerve fiber layer thickness
Time frame: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.
Resting state functional connectivity changes
Time frame: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.
White matter Integrity
Time frame: Baseline ,6-month, and every 1 year, follow-up time up to 10 years.
Number of Patients with cerebrovascular events, cardiovascular events, or death
Time frame: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 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 17 Sep 2026.
- Background: PubMed 37236211Duering 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.
- Background: PubMed 35766027Lloyd-Jones DM, Allen NB, Anderson CAM, Black T, Brewer LC, Foraker RE, Grandner MA, Lavretsky H, Perak AM, Sharma G, Rosamond W; American Heart Association. Life's Essential 8: Updating and Enhancing the American Heart Association's Construct of Cardiovascular Health: A Presidential Advisory From the American Heart Association. Circulation. 2022 Aug 2;146(5):e18-e43. doi: 10.1161/CIR.0000000000001078. Epub 2022 Jun 29.
- Individual participant dataSharing planned: No
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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 Cerebral Small Vessel Diseases and Dementia, Mixed, run by Zhejiang Provincial People's Hospital 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 3 inclusion and 9 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 17 Sep 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 Sheng Zhang, M.D. (+8618758188313, zhangsheng@hmc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mini-mental State Examination (MMSE) score (time frame: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.). 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 NCT06164262, which also lists 2 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 17 Sep 2026.