Dementia Risk Registry for Young and Middle-aged CSVD Patients in the Next 10 Years
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Individuals with CSVD.
- Who it may be relevant to
- Registry conditions: Cerebral Small Vessel Diseases, Dementia, Mixed, Health Behavior, Health Behavior, Risky. Basic parameters: 30 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Dementia Risk rEgistry for Young And Middle-aged CSVD Patients in the Next 10 Years（DREAM-10）
Overview
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.
Interventions
- Other Individuals with CSVD
This does not entail the application of interventions.
Primary outcome measures
- Mini-mental State Examination (MMSE) score [Time frame: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.]
Secondary outcome measures (8)
- The development of total brain small vessel disease burden in MRI [Time frame: Baseline ,6-month, and every 1 year, follow-up time up to 10 years.]
- Blood flow density [Time frame: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.]
- Vascular perfusion area [Time frame: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.]
- Macular fovea retinal thickness [Time frame: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.]
- Retinal nerve fiber layer thickness [Time frame: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.]
- Resting state functional connectivity changes [Time frame: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.]
- White matter Integrity [Time frame: Baseline ,6-month, and every 1 year, follow-up time up to 10 years.]
- Number of Patients with cerebrovascular events, cardiovascular events, or death [Time frame: Baseline,3-month,6-month, and every 1 year, follow-up time up to 10 years.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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:
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Other
Study locations
China · 1 center
- Zhejiang Provincial People's Hospital — Hangzhou
Publications
- 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, Rudilo PMID 37236211
- 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.000000000000 PMID 35766027
Identifiers
NCT: NCT06164262 · KY2023054