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

Privatklinik Villa Melitta

Status: Unknown

Conditions: Parkinson's

Study type: Observational

Funder types: Other

Identifiers

NCT01467960

Melitta-ApoD-2011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

180 participants in 6 patient groups

Group I

Description:

Healthy Subjects aged 20-40

Group II

Description:

Healthy Subjects aged 40-65

Group III

Description:

Healthy Subjects aged more than 65

Group A

Description:

Patients at Stage I, H\&Y classification

Group B

Description:

Patients at Stage II, H\&Y classification

Group C

Description:

Patients at Stage more than III, H\&Y classification