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Early diagnosis and characteristic analysis of cognitive impairment in Parkinson's disease: a multicenter clinical study

Early diagnosis and characteristic analysis of cognitive impairment in Parkinson's disease: a multicenter clinical study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600120588
Enrollment
Unknown
Registered
2026-03-17
Start date
2024-07-10
Completion date
Unknown
Last updated
2026-03-23

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

Conditions

Parkinson's Disease

Interventions

Healthy Control Group:None

Sponsors

Xuanwu Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Inclusion criteria for PD group: (1) All PD patients were independently diagnosed as clinically confirmed or clinically probable PD patients by 2 or more professional neurologists according to the MDS diagnostic criteria in 2015; (2) Male or female, aged 45 - 75 years; (3) Educational background was not limited, MoCA>20 points; (4) Understanding and signing informed consent form; 2. Inclusion criteria of healthy control group: (1) Age, gender, years of education matched with PD group and MoCA=26 points; (2) No complaint of memory impairment; (3) Ability to complete neuropsychological assessment tests; (4) Understanding and signing informed consent forms;

Exclusion criteria

Exclusion criteria: 1. History of serious diseases affecting brain function: such as Fazakes grade =II white matter hyperintensity, Hachinski score>4, brain trauma, history of brain surgery, encephalitis, epilepsy, etc.; 2. History of serious diseases, such as mental and psychological diseases (e.g. schizophrenia, HAMA>29 points, HAMD-17>24 points), cancer, hyperthyroidism, alcoholism, carbon monoxide poisoning, drug abuse and systemic diseases; 3. Vision and hearing abnormalities, severe aphasia or paralysis and inability to cooperate due to motor symptoms; 4. Taking anticholinergic drugs (e.g. benzhydryl).

Design outcomes

Primary

MeasureTime frame
Change in PD Cognitive Domain Assessment Scale Score from Baseline to 1 Year Follow-up;

Secondary

MeasureTime frame
Change in Cognitive-Related Biomarkers (T-tau, p-tau-181, Aß-40, Aß-42, NFL, a-synuclein) from Baseline to Follow-up;

Countries

China

Contacts

Public ContactXu Erhe

Xuanwu Hospital, Capital Medical University

xwyyxueh@163.com+86 136 5117 0965

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 3, 2026