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

NCT ID: NCT06164262

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2034-12-01

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Individuals with CSVD

This does not entail the application of interventions.

Individuals with CSVD

Intervention Type: OTHER

This does not entail the application of interventions.

Interventions

Individuals with CSVD

This does not entail the application of interventions.

Intervention Type: OTHER

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.

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.

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:

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Sheng Zhang, M.D.

Role: CONTACT

zhangsheng@hmc.edu.cn

+8618758188313

Facility Contacts

Sheng Zhang, M.D.

Role: primary

zhangsheng@hmc.edu.cn

+8618758188313

References

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.

Reference Type: BACKGROUND

PMID: 37236211 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 35766027 (View on PubMed)

Other Identifiers

KY2023054

Identifier Type: -

Identifier Source: org_study_id