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

This study is currently recruiting participants.
Verified January 2012 by Privatklinik Villa Melitta
Sponsor:
Information provided by (Responsible Party):
Andreas Waldner, Privatklinik Villa Melitta
ClinicalTrials.gov Identifier:
NCT01467960
First received: October 30, 2011
Last updated: January 25, 2012
Last verified: January 2012
History of Changes
  Purpose

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
Parkinson's

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Detection of Apolipoprotein D (ApoD) in Human Serum as Marker of Parkinson's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Privatklinik Villa Melitta:

Primary Outcome Measures:
  • Detection of Apolipoprotein D [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 1 day ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

The participants have only to give 2,5 c/c of their blood, in which Apolipoprotein D levels will be detected and quantified by a sandwich ELISA test (Uscn Life Science & Technology Company).


Estimated Enrollment: 180
Study Start Date: November 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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).

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01467960

Contacts
Contact: Andreas Waldner, MD +39 0471 471 471 waldner.andreas@villamelitta.it
Contact: Sarah Dassati, BSc +39 0471 471 471 sarahdassati@yahoo.it

Locations
Austria
Medical University Innsbruck Active, not recruiting
Innsbruck, Tirol, Austria, 6020
Italy
Privatklinik Villa Melitta Recruiting
Bozen, Südtirol, Italy, 39100
Contact: Andreas Waldner, MD     +39 0471 471 471     waldner.andreas@villamelitta.it    
Contact: Sarah Dassati, BSc     +39 0471 471 471     sarahdassati@yahoo.it    
Principal Investigator: Sarah Dassati, BSc            
Krankenhaus Bozen Not yet recruiting
Bozen, Südtirol, Italy, 39100
Contact: Rudolf Schönhuber, MD            
Principal Investigator: Rudolf Schönhuber, MD            
Sponsors and Collaborators
Privatklinik Villa Melitta
Investigators
Study Director: Andreas Waldner, MD Privatklinik Villa Melitta
Principal Investigator: Sarah Dassati, BSc Privatklinik Villa Melitta
Study Chair: Bernhard Redl, PhD Medical University Innsbruck
Study Chair: Rudolf Schönhuber, MD Krankenhaus Bozen
  More Information

Additional Information:
Participating Centre for ApoD Detection  This link exits the ClinicalTrials.gov site
Participating Centre for ApoD Detection  This link exits the ClinicalTrials.gov site
Participating Centre for ApoD Detection  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Andreas Waldner, Study Director, Privatklinik Villa Melitta
ClinicalTrials.gov Identifier: NCT01467960     History of Changes
Other Study ID Numbers: Melitta-ApoD-2011
Study First Received: October 30, 2011
Last Updated: January 25, 2012
Health Authority: Italy: National Institute of Health

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

ClinicalTrials.gov processed this record on May 19, 2013