Dementia Risk Registry Across the Multidimensional Lifespan: A 10-Year Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-85
SponsorZhejiang Provincial People's Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Individuals with CSVD
Other interventionThis does not entail the application of interventions.
Treatment groups
1,000 Participants
are divided into 1 treatment groupGroup A: Individuals with CSVD1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.Secondary outcomes
1
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.
Time frame
Baseline ,6-month, and every 1 year, follow-up time up to 10 years.2
Blood flow density
Record blood flow density (%) of OCTA.
Time frame
Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.3
Vascular perfusion area
Record vascular perfusion area (mm\^2) of OCTA.
Time frame
Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.4
Macular fovea retinal thickness
Record macular fovea retinal thickness (μm) of OCTA.
Time frame
Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.Sponsors and contacts
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Source ClinicalTrials.gov