Trial Outcomes & Findings for Apolipoprotein D (ApoD) In Human Serum As Marker Of Parkinson's Disease (NCT NCT01467960)
NCT ID: NCT01467960
Last Updated: 2013-10-30
Results Overview
Apolipoprotein D (apoD)concentration in human serum as a potential marker for Parkinson's disease (PD)
UNKNOWN
180 participants
Baseline
2013-10-30
Participant Flow
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).
Participant milestones
| Measure |
Group I
30 Healthy Subjects aged 20-40
|
Group II
30 Healthy Subjects aged 40-65
|
Group III
30 Healthy Subjects aged more than 65
|
Group A
30 Patients at Stage I, H\&Y classification
|
Group B
30 Patients at Stage II, H\&Y classification
|
Group C
30 Patients at Stage more than III, H\&Y classification
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
30
|
30
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
30
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
30
|
30
|
30
|
Reasons for withdrawal
| Measure |
Group I
30 Healthy Subjects aged 20-40
|
Group II
30 Healthy Subjects aged 40-65
|
Group III
30 Healthy Subjects aged more than 65
|
Group A
30 Patients at Stage I, H\&Y classification
|
Group B
30 Patients at Stage II, H\&Y classification
|
Group C
30 Patients at Stage more than III, H\&Y classification
|
|---|---|---|---|---|---|---|
|
Overall Study
Enrollment of patients (PD) in 09/2013
|
0
|
0
|
0
|
30
|
30
|
30
|
Baseline Characteristics
Apolipoprotein D (ApoD) In Human Serum As Marker Of Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Group I
n=30 Participants
Healthy Subjects aged 20-40
|
Group II
n=30 Participants
Healthy Subjects aged 40-65
|
Group III
n=30 Participants
Healthy Subjects aged more than 65
|
Group A
n=30 Participants
Patients at Stage I, H\&Y
|
Group B
n=30 Participants
Patients at Stage II, H\&Y
|
Group C
n=30 Participants
Patients at stage \> than II, H\&Y
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
60 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
30 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
120 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
90 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
90 Participants
n=8 Participants
|
|
Region of Enrollment
Italy
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
30 participants
n=5 Participants
|
30 participants
n=4 Participants
|
30 participants
n=21 Participants
|
30 participants
n=8 Participants
|
180 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: BaselineApolipoprotein D (apoD)concentration in human serum as a potential marker for Parkinson's disease (PD)
Outcome measures
| Measure |
Group I
n=30 Participants
Healthy Subjects aged 20-40
|
Group II
n=30 Participants
Healthy Subjects aged 40-65
|
Group III
n=30 Participants
Healthy Subjects aged more than 65
|
Group A
Patients at Stage I, H\&Y
|
Group B
Patients at Stage II, H\&Y
|
Group C
Patients at stage \> than II, H\&Y
|
|---|---|---|---|---|---|---|
|
Detection of Apolipoprotein D
|
28.28 microg / ml
Standard Deviation 4.01
|
27.73 microg / ml
Standard Deviation 7.26
|
34.61 microg / ml
Standard Deviation 9.21
|
—
|
—
|
—
|
Adverse Events
Group I
Group II
Group III
Group A
Group B
Group C
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place