Apolipoprotein D (ApoD) In Human Serum As Marker Of Parkinson's Disease

• Conditions: Parkinson's

• Registration Number: NCT01467960
• Lead Sponsor: Privatklinik Villa Melitta

Brief Summary

In Italy affected people are 200,000 and every year Parkinson new cases are 10,000. Aging is the principle risk factor of Parkinson with the possibility of its development doubling every five years after 65. Because of the increase of the social longevity and aging as the main risk factor, there are many repercussions on the health system (hospital stays and pharmaceutical costs) as on the social system (assistance- related problems). Parkinson's disease exerts an extremely negative impact on life's quality of the patient. In fact, because of Parkinson symptoms (tremor, dribble, etc), patient's social life will be reduced with the consequent development of the depression. Consequently, the early detection and treatment of Parkinson's is necessary.

To achieve this goal, Apolipoprotein D (ApoD) in human serum as a marker of the oxidative stress-inflammation vicious cycle seems most promising candidate for diagnosis.

Detailed Description

Total participants: n=180.

Study Part 1:

Health persons: n=90; Groups of health persons: n=3; Subjects per group: n=30.

Study Part 2:

Patients: n=90; Groups of patients: n=3; Subjects per group: n=30.

Study Timeline

• Study First Submitted: 2011-10-30
• Study Start: 2011-11
• Study First Submitted QC: 2011-11-08
• Study First Posted: 2011-11-09
• Primary Completion: 2013-06
• Results First Submitted: 2013-06-11
• Results First Submitted QC: 2013-06-11
• Results First Posted: 2013-08-16
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-23
• Last Update Posted: 2013-10-30
• Study Completion: 2013-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Patients with Parkinson's disease in the pathological related stages (Hoehn and Yahr)
• Persons > 20 years

Exclusion Criteria

• Patients with a neurodegenerative disorder different to Parkinson's disease
• Patients, who are post-ictus and/or traumatic brain injury (TBI)
• Patients, who are treated with antipsychotic drugs
• Obese persons (BMI > 27)
• Idiopathic normal pressure idrocephalus (INPI)
• Paget's disease
• Breast cancer
• Adenocarcinoma of the prostate
• Glucose-6-phosphate (GSD-I) deficiency
• Insuline-resistance-related disorders

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of Apolipoprotein D	Baseline	Apolipoprotein D (apoD)concentration in human serum as a potential marker for Parkinson's disease (PD)

Trial Locations

Locations (1)

Privatklinik Villa Melitta; 🇮🇹 Bozen, Südtirol, Italy