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

Health Behavior Clinical Trial

— DREAM-10  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06164262
• Other study ID #: KY2023054
• Status: Recruiting
• Start date: January 1, 2024
• Est. completion date: December 1, 2034

Study information

• Verified date: February 2024
• Source: Zhejiang Provincial People's Hospital
• Contact: Sheng Zhang, M.D.
• Phone: +8618758188313
• Email: zhangsheng[@]hmc.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 1, 2034
• Est. primary completion date: August 1, 2034
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Small Vessel Diseases
• Dementia
• Dementia, Mixed
• Health Behavior

Intervention

Other:
• Individuals with CSVD
This does not entail the application of interventions.

Locations

Country	Name	City	State
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Provincial People's Hospital

Country where clinical trial is conducted

China, 

References & 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. Erratum In: Lancet Neurol. 2023 Sep;22(9):e10. Lancet Neurol. 2023 Sep;22(9):e10. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline ,6-month, and every 1 year, follow-up time up to 10 years.
Secondary	Blood flow density	Record blood flow density (%) of OCTA.	Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.
Secondary	Vascular perfusion area	Record vascular perfusion area (mm^2) of OCTA.	Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.
Secondary	Macular fovea retinal thickness	Record macular fovea retinal thickness (µm) of OCTA.	Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.
Secondary	Retinal nerve fiber layer thickness	Record retinal nerve fiber layer thickness (µm) of OCTA.	Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.
Secondary	Resting state functional connectivity changes	The study uses Resting state functional MRI (Rs-fMRI) to measure changes of functional connectivity across regions.	Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.
Secondary	White matter Integrity	The study uses Diffusion Tensor Imaging (DTI) to obtain FA and MD values, which are used to measure changes in the integrity of white matter.	Baseline ,6-month, and every 1 year, follow-up time up to 10 years.
Secondary	Number of Patients with cerebrovascular events, cardiovascular events, or death	Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA) and cerebral hemorrhage. Cardiovascular events included angina and myocardial infarction. Death included any reason caused death.	Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.