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

NCT06164262 | Recruiting DMC

• 1 other identifier: KY2023054
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Small Vessel Diseases; Dementia, Mixed; Health Behavior; Health Behavior, Risky

Keywords

Cerebral Small Vessel Diseases; Dementia; Cardiovascular health

Outcome Measures

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.

  Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.

Secondary Outcomes (8)

• The development of total brain small vessel disease burden in MRI

  Baseline ,6-month, and every 1 year, follow-up time up to 10 years.

• Blood flow density

  Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.

• Vascular perfusion area

  Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.

• Macular fovea retinal thickness

  Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.

• Retinal nerve fiber layer thickness

  Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.

Study Arms (1)

Individuals with CSVD

This does not entail the application of interventions.

Other: Individuals with CSVD

Interventions

Individuals with CSVD OTHER

This does not entail the application of interventions.

Individuals with CSVD

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Contraindications for imaging examination.
• Exit 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.

Sponsors & Collaborators

• Zhejiang Provincial People's Hospital: lead

Study Sites (1)

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 37236211 BACKGROUND

• 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.

  PMID: 35766027 BACKGROUND

MeSH Terms

Conditions

Cerebral Small Vessel Diseases; Mixed Dementias; Health Behavior; Health Risk Behaviors; Dementia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Central Study Contacts

Sheng Zhang, M.D.

CONTACT

+8618758188313; zhangsheng@hmc.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: December 11, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): August 1, 2034
• Study Completion (Estimated): December 1, 2034
• Last Updated: May 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)