Parkinson's
Conditions
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.
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.
Interventions
None listed
Sponsors
Privatklinik Villa Melitta
Study design
Observational model
COHORT
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of Apolipoprotein D | Baseline | Apolipoprotein D (apoD)concentration in human serum as a potential marker for Parkinson's disease (PD) |
Countries
Italy
Participant flow
Recruitment details
90 healthy subjects are enrolled on the base of their age being classified in the groups I (20-40), II (40-65) and three (\>than 65). 90 patients are enrolled on the base of their disease's stage (Hoehn and Yahr classification) being classified in the groups A (I, H&Y), B (II, H&Y) and C (\> than II, H&Y).
Participants by arm
| Arm | Count |
|---|---|
| Group I Healthy Subjects aged 20-40 | 30 |
| Group II Healthy Subjects aged 40-65 | 30 |
| Group III Healthy Subjects aged more than 65 | 30 |
| Group A Patients at Stage I, H&Y | 30 |
| Group B Patients at Stage II, H&Y | 30 |
| Group C Patients at stage \> than II, H&Y | 30 |
| Total | 180 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Enrollment of patients (PD) in 09/2013 | 0 | 0 | 0 | 30 | 30 | 30 |
Baseline characteristics
| Characteristic | Group I | Group II | Group III | Group A | Group B | Group C | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 30 Participants | 30 Participants | 30 Participants | 30 Participants | 120 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 30 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 60 Participants |
| Region of Enrollment Italy | 30 participants | 30 participants | 30 participants | 30 participants | 30 participants | 30 participants | 180 participants |
| Sex: Female, Male Female | 15 Participants | 15 Participants | 15 Participants | 15 Participants | 15 Participants | 15 Participants | 90 Participants |
| Sex: Female, Male Male | 15 Participants | 15 Participants | 15 Participants | 15 Participants | 15 Participants | 15 Participants | 90 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Detection of Apolipoprotein D
Apolipoprotein D (apoD)concentration in human serum as a potential marker for Parkinson's disease (PD)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group I | Detection of Apolipoprotein D | 28.28 microg / ml | Standard Deviation 4.01 |
| Group II | Detection of Apolipoprotein D | 27.73 microg / ml | Standard Deviation 7.26 |
| Group III | Detection of Apolipoprotein D | 34.61 microg / ml | Standard Deviation 9.21 |