NCT04926909

Brief Summary

To investigate the relationship between serum cystatin C and dopamine receptor(DAT) loss in patients with parkinson's disease(PD)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
121

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 15, 2021

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

June 15, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

June 9, 2021

Last Update Submit

June 9, 2021

Conditions

Parkinson's Disease

Keywords

Cystatin C, PET-DAT

Outcome Measures

Primary Outcomes (1)

  • Cystatin C assesses the loss of dopaminergic neurons

    Explore whether Cystatin C can respond to the loss of dopaminergic neurons

    through study completion, an average of 1 year

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Pearson correlation analysis is planned, and the sample size is calculated with PASS 15.0 software. 121 participants required after sample size calculation. The calculation parameters are as follows: Power = 0.90, α=0.05, ρ0 = 0.0, and ρ1 = 0.3.

You may qualify if:

  • Patients aged between 20 and 80 years and whose laboratory results included the levels of serum Cystatin C within a month from the PET-DAT were recruited.

You may not qualify if:

  • To make the study cohort more homogeneous, PD patients with either a long-standing duration (≥5 years) or advanced Hoehn and Yahr (H\&Y) staging (≥3) were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Central Study Contacts

BaoRong Zhang, MD

CONTACT

13958167260brzhang@zju.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2021

First Posted

June 15, 2021

Study Start

July 1, 2020

Primary Completion

July 1, 2021

Study Completion

August 1, 2021

Last Updated

June 15, 2021

Record last verified: 2021-03

Locations

CN(1)