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

NCT ID: NCT01467960

Last Updated: 2013-10-30

Study Results

Results available

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Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-11-30

Brief Summary

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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

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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.

Conditions

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Parkinson's

Study Design

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Observational Model Type

COHORT

Study Groups

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Group I

Healthy Subjects aged 20-40

No interventions assigned to this group

Group II

Healthy Subjects aged 40-65

No interventions assigned to this group

Group III

Healthy Subjects aged more than 65

No interventions assigned to this group

Group A

Patients at Stage I, H\&Y classification

No interventions assigned to this group

Group B

Patients at Stage II, H\&Y classification

No interventions assigned to this group

Group C

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Privatklinik Villa Melitta

OTHER

Sponsor Role lead

Responsible Party

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Andreas Waldner

Study Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Waldner, MD

Role: STUDY_DIRECTOR

Privatklinik Villa Melitta

Sarah Dassati, BSc

Role: PRINCIPAL_INVESTIGATOR

Privatklinik Villa Melitta

Locations

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Privatklinik Villa Melitta

Bolzano, Südtirol, Italy

Site Status

Countries

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Austria Italy

References

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Fall RR. Stabilization of an acetyl-coenzyme A carboxylase complex from Pseudomonas citronellolis. Biochim Biophys Acta. 1976 Dec 20;450(3):475-80. doi: 10.1016/0005-2760(76)90022-9.

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Hong JS. An ecf mutation in Escherichia coli pleiotropically affecting energy coupling in active transport but not generation or maintenance of membrane potential. J Biol Chem. 1977 Dec 10;252(23):8582-8. No abstract available.

Reference Type RESULT
PMID: 21876 (View on PubMed)

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Reference Type RESULT
PMID: 19176 (View on PubMed)

Related Links

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http://www.villamelitta.it

Participating Centre for ApoD Detection

Other Identifiers

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Melitta-ApoD-2011

Identifier Type: -

Identifier Source: org_study_id