NCT01467960

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2011

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 9, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
3 months until next milestone

Results Posted

Study results publicly available

August 16, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

October 30, 2013

Status Verified

September 1, 2013

Enrollment Period

1.6 years

First QC Date

October 30, 2011

Results QC Date

June 11, 2013

Last Update Submit

September 23, 2013

Conditions

Parkinson's

Outcome Measures

Primary Outcomes (1)

  • Detection of Apolipoprotein D

    Apolipoprotein D (apoD)concentration in human serum as a potential marker for Parkinson's disease (PD)

    Baseline

Study Arms (6)

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

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • Patients with Parkinson's disease in the pathological related stages (Hoehn and Yahr)
  • Persons \> 20 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Privatklinik Villa Melitta

Bolzano, Südtirol, 39100, Italy

Location

Related Publications (12)

  • Bennett MD. The time and duration of meiosis. Philos Trans R Soc Lond B Biol Sci. 1977 Mar 21;277(955):201-26. doi: 10.1098/rstb.1977.0012.

    PMID: 16285BACKGROUND

  • Patterson D, Carnright DV. Biochemical genetic analysis of pyrimidine biosynthesis in mammalian cells: I. Isolation of a mutant defective in the early steps of de novo pyrimidine synthesis. Somatic Cell Genet. 1977 Sep;3(5):483-95. doi: 10.1007/BF01539120.

    PMID: 21463BACKGROUND

  • Arnesen K, Nordstoga K. Ocular encephalitozoonosis (nosematosis) in blue foxes. Polyarteritis nodosa and cataract. Acta Ophthalmol (Copenh). 1977 Aug;55(4):641-51. doi: 10.1111/j.1755-3768.1977.tb05662.x.

    PMID: 19918BACKGROUND

  • Weidler DJ, Sieck GC. A study of ion binding in the hemolymph of Periplaneta americana. Comp Biochem Physiol A Comp Physiol. 1977;56(1A):11-4. doi: 10.1016/0300-9629(77)90433-9. No abstract available.

    PMID: 11058BACKGROUND

  • Bergdahl B, Andersson KE. Stability in vitro of methylproscillaridin. Eur J Clin Pharmacol. 1977 Apr 20;11(4):267-71. doi: 10.1007/BF00607675.

    PMID: 16755BACKGROUND

  • Kovatsis A, Kovatsi-Kotsaki V, Elezoglou B, Kounenis G. Physiological antagonism between PGE2, PGA1, PGF1-alpha and NADP, beta-NAD on isolated rabbit jejunum. Arzneimittelforschung. 1976;26(11):1997-9.

    PMID: 14647BACKGROUND

  • Shankar GM, Walsh DM. Alzheimer's disease: synaptic dysfunction and Abeta. Mol Neurodegener. 2009 Nov 23;4:48. doi: 10.1186/1750-1326-4-48.

    PMID: 19930651RESULT

  • Dalmark M. Chloride in the human erythrocyte: distribution and transport between cellular and extracellular fluids and structural features of the cell membrane. Prog Biophys Mol Biol. 1976;31(2):145-64. No abstract available.

    PMID: 10601RESULT

  • Miller J, Wallace D, Grieco MH, Frenkel R, Larsen K. Double-blind trial of oral carbuterol in bronchial asthma. Ann Allergy. 1977 Jul;39(1):12-7.

    PMID: 18957RESULT

  • 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.

    PMID: 12801RESULT

  • 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.

    PMID: 21876RESULT

  • Kricka LJ, Carter TJ. A method for enhancing the stability of thiol-containing enzymes immobilised on nylon. Clin Chim Acta. 1977 Aug 15;79(1):141-7. doi: 10.1016/0009-8981(77)90471-5.

    PMID: 19176RESULT

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Serum

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Results Point of Contact

Title
Sarah Dassati
Organization
Villa Melitta
sarahdassati@yahoo.it
+39 0471 471

Study Officials

  • Andreas Waldner, MD

    Privatklinik Villa Melitta

    STUDY DIRECTOR

  • Sarah Dassati, BSc

    Privatklinik Villa Melitta

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Director

Study Record Dates

First Submitted

October 30, 2011

First Posted

November 9, 2011

Study Start

November 1, 2011

Primary Completion

June 1, 2013

Study Completion

November 1, 2013

Last Updated

October 30, 2013

Results First Posted

August 16, 2013

Record last verified: 2013-09

Locations

IT(1)