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Clinical trial on the diagnostic value and safety of the auxiliary evaluation system of brain physiology and cognitive function for the auxiliary diagnosis of mild cognitive impairment

Clinical trial on the diagnostic value and safety of the auxiliary evaluation system of brain physiology and cognitive function for the auxiliary diagnosis of mild cognitive impairment

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200064458
Enrollment
Unknown
Registered
2022-10-09
Start date
2022-10-09
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Cognitive impairment

Interventions

Gold Standard:According to the diagnostic criteria and procedures of MCI in 2018 Chinese Guidelines for Diagnosis and Treatment of Dementia and Cognitive Impairment (V) : Diagnosis and Treatment of Mi
Index test:The auxiliary evaluation system of brain physiology and cognitive function

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
65 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Aged >= 65 years, no gender limit; 2. Suspected MCI patients and suspected normal cognitive function; 3. Subjects can understand the purpose of the study, show sufficient compliance with the study plan, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Blind people, patients with obvious atrophy in one eye or both eyes, self-reported or assessed by researchers as suffering from severe cataract, glaucoma, pink eye, severe inflammation of eye-related tissues, retinal detachment, and patients with eye appearance conditions that do not meet the requirements of eye movement detection, such as severely drooping eyelids leading to occlusion of half or more of the pupil, or severely occlusion of the pupil due to other conditions; 2. Those judged by the researchers to be unable to communicate normally; 3. Those who are participating in other experiments and have not yet been included in the group and those who have participated in other experimental projects have been included in the group for less than 3 months; 4. Identify dementia, mental illness, or neurological or psychiatric disorders that researchers have determined affect cognitive function; 5. In order to exclude the influence of other basic diseases on clinical judgment, fasting blood glucose of diabetic patients > 7mmol/L, moderate-severe hypertension patients (diastolic blood pressure > 105 mmHg), thyroid function TSH > 4.2umol/L were excluded; 6. Patients who have received cognitive improvement therapy; 7. Other conditions deemed unsuitable for inclusion by the researcher.

Design outcomes

Primary

MeasureTime frame
Sensitivity;Specificity;

Secondary

MeasureTime frame
Accuracy;Overall use evaluation of software;

Countries

China

Contacts

Public ContactChen Lei

West China Hospital, Sichuan University

leilei_25@126.com+86 18980605819

Outcome results

None listed

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