Observational Study on Dementia Risk in Adults Aged 30 to 60 with Cerebral Small Vessel Disease DREAM-10
Led by Zhejiang Provincial People's Hospital · Updated on 2025-05-21
1000
Participants Needed
1
Research Sites
17 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating age-related cerebral small-vessel disease CSVD, a common cause of dementia especially in people over 60, to understand its impact on younger adults aged 30 to 60. This observational, prospective study follows individuals without diagnosed dementia but showing brain imaging signs of CSVD, aiming to track cognitive changes and potential dementia risk over a 10-year period. The study is sponsored by Zhejiang Provincial Peoples Hospital and focuses on identifying factors predicting dementia in these younger and middle-aged adults.
Participants in this study will be observed without receiving any interventions. Data collection includes clinical information, detailed neuropsychological tests, multimodal magnetic resonance imaging MRI, and retinal imaging using Optical Coherence Tomography Angiography OCTA. Imaging features evaluated include small subcortical infarcts, lacunes, white matter changes, perivascular spaces, microbleeds, brain atrophy, and cortical siderosis. Follow-up assessments are scheduled at baseline, 3 months, 6 months, and then yearly for up to 10 years.
During the study, participants will undergo repeated evaluations including the Mini-Mental State Examination MMSE to monitor cognitive function. Additional measures include MRI markers of small vessel disease progression, blood flow density, vascular perfusion area, retinal thickness, nerve fiber layer thickness, brain connectivity changes, white matter integrity, and monitoring of cerebrovascular or cardiovascular events and mortality. This comprehensive monitoring supports understanding the long-term risks and disease progression associated with CSVD in younger adults.
CONDITIONS
Brief Title
Dementia Risk Registry for Young and Middle-aged CSVD Patients in the Next 10 Years
Research Team
S
Sheng Zhang, M.D.
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Patients with MRI markers of cerebral small vessel disease such as recent small subcortical infarcts, lacunes, white matter hyperintensities, perivascular spaces, microbleeds, or cortical siderosis
Aged between 30 and 60 years
Signed informed consent provided
You will not qualify if you...
Unable to cooperate with study assessments
Known diagnosis of dementia
Other cognitive diseases like Alzheimer's, Parkinson's, or thyroid disease
Serious systemic illnesses including heart, liver, kidney diseases or major mental illness
Contraindications for imaging examinations
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Baseline assessment
Participants undergo baseline assessments including MRI scans and cognitive testing to evaluate cerebral small vessel disease markers and brain function.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 10 years
Participants are monitored over time with repeated assessments including cognitive tests, MRI imaging, and other measurements to track brain health and disease progression.
Visits at 3 months, 6 months, and then annually for up to 10 years
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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