Clinical trial NCT06164262: Dementia Risk Registry for Young and Middle-aged CSVD Patients in the Next 10 Years
Official title: Dementia Risk rEgistry for Young And Middle-aged CSVD Patients in the Next 10 Years（DREAM-10）
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Small Vessel Diseases
Dementia, Mixed
Health Behavior
Health Behavior, Risky
Keywords: Cerebral Small Vessel Diseases
Dementia
Cardiovascular health
Lead sponsor: Zhejiang Provincial People's Hospital
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

Brief 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. 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: 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.

Primary outcomes:
measure: Mini-mental State Examination (MMSE) score
timeFrame: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.
Secondary outcomes:
measure: The development of total brain small vessel disease burden in MRI
timeFrame: Baseline ,6-month, and every 1 year, follow-up time up to 10 years.
measure: Blood flow density
timeFrame: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.
measure: Vascular perfusion area
timeFrame: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.
measure: Macular fovea retinal thickness
timeFrame: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.
measure: Retinal nerve fiber layer thickness
timeFrame: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.
measure: Resting state functional connectivity changes
timeFrame: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.
measure: White matter Integrity
timeFrame: Baseline ,6-month, and every 1 year, follow-up time up to 10 years.
measure: Number of Patients with cerebrovascular events, cardiovascular events, or death
timeFrame: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
Study officials:
References:
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citation: 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.