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The outcomes and mechanisms of cerebral small vessel disease with mild cognitive impairment: a prospective cohort study

The outcomes and mechanisms of cerebral small vessel disease with mild cognitive impairment: a prospective cohort study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200062491
Enrollment
Unknown
Registered
2022-08-09
Start date
2022-07-31
Completion date
Unknown
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral small vessel disease

Interventions

CSVD:None
MCI:None

Sponsors

The First Affiliated Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. 60 patients with cognitive dysfunction related to cerebrovascular disease (with or without Alzheimer's disease) : (1) Outpatients or inpatients in the neurology department of the Center aged 50-80 years; (2) He/she complained of cognitive impairment and was found to have mild cognitive impairment by objective examination, not dementia. CDR score =0.5 or 1; MMSE score >=20 (primary school culture) or >=24 (secondary school culture and above), daily living ability is independent (mRS <=2); (3) Moderate to severe white matter lesions on imaging (Fazekas grade 2,3) were the main inclusion criteria. Other small vascular signs, such as lacunar infarcts (lacunar infarcts), brain microhemorrhage, enlarged perivascular space (EPVS to infarcts), and brain atrophy to infarcts; (4) Imaging evidence of small vascular diseases, mainly white matter lesions, can explain most of the existing cognitive dysfunction. 2. 30 patients with simple AD-derived MCI: (1) Outpatients and inpatients aged 50-80 in the Department of Neurology of the Center; (2) In accordance with the 2011 NIA-AA diagnostic criteria for MCI stage of Alzheimer's disease; 3. 30 normal people: (1) Family members or other staff of outpatients and inpatients in the neurology department of the Center aged 50-80; (2) Normal cognition.

Exclusion criteria

Exclusion criteria: 1. Severe aphasia or other factors that might preclude completion of neuropsychological assessments or MRI; 2. Refusal or inability to give written informed consent to participate in the study or refusal to come for follow up visits; 3. Contraindications for MRI (e.g., pregnancy, metal implants, and claustrophobia); 4. Cortical or large subcortical infarct (=20 mm in diameter), acute hemorrhagic stroke, cardioembolic stroke; 5. Disorders other than Leukoaraiosis and AD that would affect cognition (e.g., Lewy bodies dementia, frontotemporal dementia, autoimmune encephalitis, and etc); 6. Presence of non-vascular leukoencephalopathy, e.g. multiple sclerosis, poisoning, brain radiotherapy, adult white matter dysplasia, metabolic encephalopathy Diseases, etc; 7. Other severe cerebral diseases: e.g., brain malignancy, brain trauma, alcoholic encephalopathy, Creutzfeldt-jakob disease, severe mental disorders, etc.

Design outcomes

Primary

MeasureTime frame
Neuropsychological assessment;

Secondary

MeasureTime frame
Blood biomarkers;EEG;Demographic data;Imaging data;

Countries

China

Contacts

Public ContactBenyan Luo

The First Affiliated Hospital, Zhejiang University School of Medicine

luobenyan@zju.edu.cn+86 0571-87235104

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026