Clinical trial NCT01467960: Apolipoprotein D (ApoD) In Human Serum As Marker Of Parkinson's Disease
Official title: Detection of Apolipoprotein D (ApoD) in Human Serum as Marker of Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson's
Lead sponsor: Privatklinik Villa Melitta
Sponsor class: OTHER
First posted: 2011-11-09
Enrollment: 180
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the recruited subjects will be either healthy people group or patients with a defined diagnosis of Parkinson (classification of Hoehn and Yahr).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Detection of Apolipoprotein D
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bozen
country: Italy
facility: Privatklinik Villa Melitta
state: Südtirol
Study officials:
affiliation: Privatklinik Villa Melitta
name: Andreas Waldner, MD
role: STUDY_DIRECTOR
affiliation: Privatklinik Villa Melitta
name: Sarah Dassati, BSc
role: PRINCIPAL_INVESTIGATOR
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