Dementia Risk Registry for Young and Middle-aged CSVD Patients in the Next 10 Years (DREAM-10)

Dementia Risk rEgistry for Young And Middle-aged CSVD Patients in the Next 10 Years（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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Small Vessel Diseases; Health Behavior; Dementia, Mixed; Health Behavior, Risky
• Intervention / Treatment: Other: Individuals with CSVD

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Sheng Zhang, M.D.; Phone Number: +8618758188313; Email: zhangsheng@hmc.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Zhejiang Provincial People's Hospital
      • Contact: Sheng Zhang, M.D.; Phone Number: +8618758188313; Email: zhangsheng@hmc.edu.cn
      • Principal Investigator: Sheng Zhang, M.D.
      • Sub-Investigator: Weitao Yu, B.S.Med

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

1. 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.
2. Patients aged from 30 to 60 years.
3. Sign informed consent.

Exclusion Criteria:

1. Unable to cooperate with inspectors.
2. Known dementia.
3. Other cognitive diseases (such as Alzheimer's disease, Parkinson's disease, or thyroid disease).
4. Serious systemic illness, such as heart, liver, kidney disease or major mental illness.
5. Contraindications for imaging examination.

Exit Criteria:

1. Not meet the inclusion criteria.
2. For any poor adherence, not comply with the requirements of the follow-up, or safety reasons determined by investigator.
3. Any adverse or serious adverse events during the study period judged by investigator.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Individuals with CSVD; This does not entail the application of interventions.	Other: Individuals with CSVD; This does not entail the application of interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline ,6-month, and every 1 year, follow-up time up to 10 years.
Blood flow density	Record blood flow density (%) of OCTA.	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.	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.	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.	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.	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.	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.	Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.

Collaborators and Investigators

• Sponsor: Zhejiang Provincial People's Hospital

Publications and helpful links

General Publications

• Lloyd-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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): August 1, 2034
• Study Completion (Estimated): December 1, 2034

Study Registration Dates

• First Submitted: November 24, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Actual): December 11, 2023

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Dementia; Cerebral Small Vessel Diseases; Cardiovascular health
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Cerebral Small Vessel Diseases
• Other Study ID Numbers: KY2023054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No