Actively Recruiting

Age: 30Years - 60Years
All Genders
ID06164262

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

Led by Zhejiang Provincial People's Hospital · Updated on 2025-05-21

1000

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

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 People's 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

Who Can Participate

Age: 30Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

Trial Site Locations

Total: 1 location

1

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China, 310000

Actively Recruiting

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Research Team

S

Sheng Zhang, M.D.

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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Published Research Related To This Trial

Life's Essential 8: Updating and Enhancing the American Heart Association's Construct of Cardiovascular Health: A Presidential Advisory From the American Heart Association.

Donald M Lloyd-Jones, Norrina B Allen, Cheryl A M Anderson...

https://pubmed.ncbi.nlm.nih.gov/35766027