Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01467960
Other study ID # Melitta-ApoD-2011
Secondary ID
Status Enrolling by invitation
Phase N/A
First received October 30, 2011
Last updated September 23, 2013
Start date November 2011
Est. completion date November 2013

Study information

Verified date September 2013
Source Privatklinik Villa Melitta
Contact n/a
Is FDA regulated No
Health authority Italy: National Institute of Health
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 180
Est. completion date November 2013
Est. primary completion date June 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years and older
Eligibility 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 Design

Observational Model: Cohort


Related Conditions & MeSH terms


Locations

Country Name City State
Italy Privatklinik Villa Melitta Bozen Südtirol

Sponsors (1)

Lead Sponsor Collaborator
Privatklinik Villa Melitta

Country where clinical trial is conducted

Italy, 

References & Publications (12)

Arnesen K, Nordstoga K. Ocular encephalitozoonosis (nosematosis) in blue foxes. Polyarteritis nodosa and cataract. Acta Ophthalmol (Copenh). 1977 Aug;55(4):641-51. — View Citation

Bennett MD. The time and duration of meiosis. Philos Trans R Soc Lond B Biol Sci. 1977 Mar 21;277(955):201-26. Review. — View Citation

Bergdahl B, Andersson KE. Stability in vitro of methylproscillaridin. Eur J Clin Pharmacol. 1977 Apr 20;11(4):267-71. — View Citation

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. Review. — View Citation

Fall RR. Stabilization of an acetyl-coenzyme A carboxylase complex from Pseudomonas citronellolis. Biochim Biophys Acta. 1976 Dec 20;450(3):475-80. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Detection of Apolipoprotein D Apolipoprotein D (apoD)concentration in human serum as a potential marker for Parkinson's disease (PD) Baseline Yes
See also
  Status Clinical Trial Phase
Recruiting NCT05516719 - Longitudinal Investigation of I2BS in PD
Enrolling by invitation NCT02670161 - Quality Improvement and Practice Based Research in Neurology Using the EMR Phase 4
Recruiting NCT05518617 - Molecular and Functional Imaging in Monogenic PD.
Recruiting NCT05516732 - Serotonin Release in Premotor and Motor PD
Terminated NCT02315781 - tDCS in Parkinson's Disease With Depression N/A
Recruiting NCT06036433 - Light Therapy Plus Exercise to Improve Motor, Non-Motor Symptoms and QoL in Parkinson's Disease N/A
Completed NCT02271685 - Sound Estimation and Accuracy Task N/A
Withdrawn NCT02177149 - Nurse Management of Neuromodulation Therapy N/A
Completed NCT02468804 - Cognitive Dysfunction In Parkinson's N/A
Withdrawn NCT02561715 - Lack of Awareness of Symptoms (Anosognosia) in PD: An Observational Study for People With Parkinson's