Study for the Early Diagnosis of Parkinson's Disease

NCT02283073 | Unknown

• 5 other identifiers: PDx00182/14TASMC -14-TG-0489-14-TLV-CTIL1735-14-SMC0463-14-RMB
• Study Type: observational
• Target: 410
• Locations: 2 countries
• Sites: 6

Brief Summary

The main objective of the study is to design and validate the blood based PDx gene expression and miRNA assay for the early diagnosis of Parkinson's disease patients. Differential diagnosis includes patients with Multiple System Atrophy, Progressive Supranuclear Palsy, Corticobasal Degeneration, Lewy Body Dementia, Essential Tremor and Normal Controls.

Conditions

Parkinson's Disease, Idiopathic

Keywords

Diagnosis

Outcome Measures

Primary Outcomes (1)

• The Diagnostic Accuracy of PDx mRNA Assay in Diagnosing Idiopathic Parkinson's Disease

  Investigate the diagnostic accuracy of the PDx gene expression assay, comprised of 5-6 expressed genes (mRNA - RQ-PCR), to differentiate patients with Idiopathic Parkinson's disease from the Differential Diagnosis Group. Diagnostic Accuracy includes sensitivity, specificity, likelihood ratios and the area under the receiver operating characteristic (ROC) curve. Diagnostic Accuracy will be calculated by comparing the PDx assay results to the Gold Standard Diagnosis, which will be the Clinical diagnosis of the Patient one year after the first and only visit (day of blood collection). The physician investigator will be contacted if there was any change in the baseline diagnosis one year after blood collection according to routine clinical findings.

  One year from enrollment

Secondary Outcomes (3)

• Diagnostic Accuracy of each one of the PDx assay's expressed genes for Differentiating Idiopathic Parkinson's Disease Patients from Atypical Parkinsonism Patients.

  One year from enrollment

• Diagnostic Accuracy of each one of the PDx assay's expressed genes for Differentiating Idiopathic Parkinson's Disease Patients from Essential Tremor Patients.

  One year from enrollment

• Diagnostic Accuracy of each one of the PDx assay's expressed genes for Differentiating Idiopathic Parkinson's Disease Patients from Healthy Controls.

  One year from enrollment

Study Arms (2)

Idiopathic Parkinson's disease

Patient with clinical diagnosis of Idiopathic Parkinson's Disease according to Queen Square Brain Bank Criteria up to one year prior to enrollment in study.

Differential Diagnosis Group

MSA, PSP, CBD, Lewy body dementia, Essential Tremor, and Healthy Controls

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Movement disorder clinics

You may qualify if:

• Patient is able and willing to read the informed consent form
• Patient with clinical diagnosis of Idiopathic Parkinson's Disease according to Queen Square Brain Bank Criteria up to one year prior to enrollment in study
• Patient with diagnosis of MSA, PSP, CBD, Lewy Body Dementia, Essential Tremor or Healthy Control
• Men and Women aged 40-80 years
• Willing and able to comply with procurement of blood sample

You may not qualify if:

• Any medical, psychiatric or other conditions which, in the opinion of the investigator, would preclude participation
• Pregnancy

Sponsors & Collaborators

• Bio Shai Ltd.: lead

Study Sites (6)

Rambam Health Care Campus

Haifa, 31096,, Israel

Location

Rabin Medical Center

Petach Tikvah, 4941492, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

Assaf Harofeh Medical Center

Ẕerifin, 70300, Israel

Location

Pisa University Hospital

Pisa, 56126, Italy

Location

Related Publications (2)

• Berardelli A, Wenning GK, Antonini A, Berg D, Bloem BR, Bonifati V, Brooks D, Burn DJ, Colosimo C, Fanciulli A, Ferreira J, Gasser T, Grandas F, Kanovsky P, Kostic V, Kulisevsky J, Oertel W, Poewe W, Reese JP, Relja M, Ruzicka E, Schrag A, Seppi K, Taba P, Vidailhet M. EFNS/MDS-ES/ENS [corrected] recommendations for the diagnosis of Parkinson's disease. Eur J Neurol. 2013 Jan;20(1):16-34. doi: 10.1111/ene.12022.

  PMID: 23279440 BACKGROUND

• Ma YM, Zhao L. Mechanism and Therapeutic Prospect of miRNAs in Neurodegenerative Diseases. Behav Neurol. 2023 Nov 23;2023:8537296. doi: 10.1155/2023/8537296. eCollection 2023.

  PMID: 38058356 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

The mRNA in blood samples will be transcribed to cDNA.

MeSH Terms

Conditions

Parkinson Disease; Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ofer Gonen, MD

  Assaf-Harofeh Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2014
• First Posted: November 5, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 10, 2018

Record last verified: 2018-07

Locations

IL (5); IT (1)