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

September 23, 2013 updated by: Andreas Waldner, Privatklinik Villa Melitta

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

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.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Actual)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Südtirol
      • Bozen, Südtirol, Italy, 39100
        • Privatklinik Villa Melitta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of Apolipoprotein D
Time Frame: Baseline
Apolipoprotein D (apoD)concentration in human serum as a potential marker for Parkinson's disease (PD)
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Privatklinik Villa Melitta

Investigators

  • Study Director: Andreas Waldner, MD, Privatklinik Villa Melitta
  • Principal Investigator: Sarah Dassati, BSc, Privatklinik Villa Melitta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Anticipated)

November 1, 2013

Study Registration Dates

First Submitted

October 30, 2011

First Submitted That Met QC Criteria

November 8, 2011

First Posted (Estimate)

November 9, 2011

Study Record Updates

Last Update Posted (Estimate)

October 30, 2013

Last Update Submitted That Met QC Criteria

September 23, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Melitta-ApoD-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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