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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01467960
Recruitment Status : Unknown
Verified September 2013 by Andreas Waldner, Privatklinik Villa Melitta.
Recruitment status was:  Enrolling by invitation
First Posted : November 9, 2011
Results First Posted : August 16, 2013
Last Update Posted : October 30, 2013
Information provided by (Responsible Party):
Andreas Waldner, 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.

Condition or disease

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 Type : Observational
Actual Enrollment : 180 participants
Observational Model: Cohort
Official Title: Detection of Apolipoprotein D (ApoD) in Human Serum as Marker of Parkinson's Disease
Study Start Date : November 2011
Actual Primary Completion Date : June 2013
Estimated Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group I
Healthy Subjects aged 20-40
Group II
Healthy Subjects aged 40-65
Group III
Healthy Subjects aged more than 65
Group A
Patients at Stage I, H&Y classification
Group B
Patients at Stage II, H&Y classification
Group C
Patients at Stage more than III, H&Y classification

Primary Outcome Measures :
  1. Detection of Apolipoprotein D [ Time Frame: Baseline ]
    Apolipoprotein D (apoD)concentration in human serum as a potential marker for Parkinson's disease (PD)

Biospecimen Retention:   Samples With DNA

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01467960

Privatklinik Villa Melitta
Bozen, Südtirol, Italy, 39100
Sponsors and Collaborators
Privatklinik Villa Melitta
Study Director: Andreas Waldner, MD Privatklinik Villa Melitta
Principal Investigator: Sarah Dassati, BSc Privatklinik Villa Melitta

Additional Information:
Publications of Results:
Other Publications:
Responsible Party: Andreas Waldner, Study Director, Privatklinik Villa Melitta Identifier: NCT01467960     History of Changes
Other Study ID Numbers: Melitta-ApoD-2011
First Posted: November 9, 2011    Key Record Dates
Results First Posted: August 16, 2013
Last Update Posted: October 30, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases