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

Parkinson's Clinical Trial

— ApoD  

Official title:

Detection of Apolipoprotein D (ApoD) in Human Serum as Marker of Parkinson's Disease

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01467960
• Other study ID #: Melitta-ApoD-2011
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 30, 2011
• Last updated: September 23, 2013
• Start date: November 2011
• Est. completion date: November 2013

Study information

• Verified date: September 2013
• Source: Privatklinik Villa Melitta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 180
• Est. completion date: November 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Observational Model: Cohort

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's

Locations

Country	Name	City	State
Italy	Privatklinik Villa Melitta	Bozen	Südtirol

Sponsors (1)

Lead Sponsor	Collaborator
Privatklinik Villa Melitta

Country where clinical trial is conducted

Italy, 

References & Publications (12)

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Patterson D, Carnright DV. Biochemical genetic analysis of pyrimidine biosynthesis in mammalian cells: I. Isolation of a mutant defective in the early steps of de novo pyrimidine synthesis. Somatic Cell Genet. 1977 Sep;3(5):483-95. — View Citation

Shankar GM, Walsh DM. Alzheimer's disease: synaptic dysfunction and Abeta. Mol Neurodegener. 2009 Nov 23;4:48. doi: 10.1186/1750-1326-4-48. — View Citation

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* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of Apolipoprotein D	Apolipoprotein D (apoD)concentration in human serum as a potential marker for Parkinson's disease (PD)	Baseline	Yes

External Links

•   Participating Centre for ApoD Detection
•   Participating Centre for ApoD Detection