Parkinson'sApoDNCT01467960
Apolipoprotein D (ApoD) In Human Serum As Marker Of Parkinson's Disease
An observational study of Parkinson's, run by Privatklinik Villa Melitta at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson's
- How many people
- 180 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2011to Nov 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- Patients with Parkinson's disease in the pathological related stages (Hoehn and Yahr)
- Persons > 20 years
Who cannot join
- 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
Show all 10Show fewer
- Breast cancer
- Adenocarcinoma of the prostate
- Glucose-6-phosphate (GSD-I) deficiency
- Insuline-resistance-related disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Parkinson's
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Detection of Apolipoprotein D
Apolipoprotein D (apoD)concentration in human serum as a potential marker for Parkinson's disease (PD)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2013
- Study completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Parkinson'sStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Privatklinik Villa Melitta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Waldner, Privatklinik Villa Melitta
- Investigators
- Andreas Waldner, MD, Study director, Privatklinik Villa MelittaSarah Dassati, BSc, Principal investigator, Privatklinik Villa Melitta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467960
- Sponsor's protocol ID
- Melitta-ApoD-2011
- Acronym
- ApoD
- Status last verified
- Sep 2013
- First submitted
- 30 Oct 2011
- Last updated
- 30 Oct 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 16285Patterson 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.
PubMed 21463Arnesen 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.
PubMed 19918Weidler 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.
PubMed 11058Bergdahl B, Andersson KE. Stability in vitro of methylproscillaridin. Eur J Clin Pharmacol. 1977 Apr 20;11(4):267-71. doi: 10.1007/BF00607675.
PubMed 16755Kovatsis 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.
PubMed 14647Shankar GM, Walsh DM. Alzheimer's disease: synaptic dysfunction and Abeta. Mol Neurodegener. 2009 Nov 23;4:48. doi: 10.1186/1750-1326-4-48.
PubMed 19930651Dalmark 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.
PubMed 10601Miller 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.
PubMed 18957Fall 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.
PubMed 12801Hong 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.
PubMed 21876Kricka 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.
PubMed 19176
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Apolipoprotein D (ApoD) in Human Serum as Marker of Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01467960
- Acronym / sponsor ID
- ApoD / Melitta-ApoD-2011
- Conditions
- Parkinson's
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Privatklinik Villa MelittaUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Nov 2013 (estimated)
- First posted
- 9 Nov 2011 (estimated)
- Results
- Posted 16 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- Patients with Parkinson's disease in the pathological related stages (Hoehn and Yahr)
- Persons > 20 years
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection of Apolipoprotein D
Time frame: Baseline
Apolipoprotein D (apoD)concentration in human serum as a potential marker for Parkinson's disease (PD)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16285Bennett 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.
- Background: PubMed 21463Patterson 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.
- Background: PubMed 19918Arnesen 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.
- Background: PubMed 11058Weidler 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.
- Background: PubMed 16755Bergdahl B, Andersson KE. Stability in vitro of methylproscillaridin. Eur J Clin Pharmacol. 1977 Apr 20;11(4):267-71. doi: 10.1007/BF00607675.
- Background: PubMed 14647Kovatsis 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.
- Results publication: PubMed 19930651Shankar GM, Walsh DM. Alzheimer's disease: synaptic dysfunction and Abeta. Mol Neurodegener. 2009 Nov 23;4:48. doi: 10.1186/1750-1326-4-48.
- Results publication: PubMed 10601Dalmark 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.
- Results publication: PubMed 18957Miller 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.
- Results publication: PubMed 12801Fall 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.
- Results publication: PubMed 21876Hong 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.
- Results publication: PubMed 19176Kricka 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.
- Participating Centre for ApoD DetectionLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Waldner, MD study director
Privatklinik Villa Melitta
Sarah Dassati, BSc principal investigator
Privatklinik Villa Melitta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's, run by Privatklinik Villa Melitta at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of Apolipoprotein D (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01467960, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2013.