The Sensitivity and Specificity of Canine Detection of Parkinson's Disease

NCT04613531 | Completed

• 1 other identifier: Xiang Ya 0005
• Study Type: observational
• Target: 1,198
• Locations: 1 country
• Sites: 1

Brief Summary

People sometimes report that their relatives who have been diagnosed with Parkinson's disease (PD) have a unique smell. A previous study has demonstrated that PD patients do have smell that is different from that of healthy people. Sniffer dogs have long been used to identify criminals, and recently been used to identify subject with cancer. The investigators hypothesized that sniffer dogs may be able to identify PD patients.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• The specificity and sensitivity of the identification of PD patients from non-PD by at least 2 out of 3 sniffer dogs

  Sensitivity = number of samples of PD patients that were correctly identified by dogs/\[number of samples of PD patients that were correctly identified+ number of samples of PD patients missed by the dogs\]. One sample will be taken per patient. Specificity = number of samples of non-PD subjects that were correctly identified by dogs/\[number of samples of non-PD subjects that were correctly identified by dogs + number of non-PD subjects that were identified as PD\]. One sample will be taken per subject.

  Samples taken at the time of participant enrolment and assessed by the sniffer dogs within 20 weeks

Secondary Outcomes (1)

• Assess the accuracy of identification by sniffer dogs for PD patients with disease duration over five years and for those with disease duration within five years of diagnosis.

  Samples taken at the time of participant enrolment and assessed by the sniffer dogs within 20 weeks

Study Arms (2)

Participants with PD

patients with clinically diagnosed Parkinson's disease

Participants without PD

participants clinically diagnosed without Parkinsons' Disease

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

PD patients and other subjects in clinics

You may qualify if:

• Clinically established PD patients
• Clearly non-PD subjects will be recruited as controls

You may not qualify if:

• subjects with tremor or decrease of olfactory power or with rapid eye movement sleep behavior, obvious constipation, and depression.
• subjects who are taking antipsychotics.
• subjects with incomplete data.

Sponsors & Collaborators

• Central South University: lead
• University of South China: collaborator
• Mingji Hospital: collaborator

Study Sites (1)

XiangYa Hospital

Changsha, Hunan, 410008, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

smell from participants' upper back

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Chang-Qing Gao, MD,PhD

  Xiang-Ya Hospital, Central South University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for studies in laboratory animals

Study Record Dates

• First Submitted: October 28, 2020
• First Posted: November 3, 2020
• Study Start: November 1, 2020
• Primary Completion: January 22, 2021
• Study Completion: January 22, 2021
• Last Updated: September 27, 2021

Record last verified: 2021-09

Locations

CN (1)