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)

Recruitment status

UNKNOWN

Target enrollment

180 participants

Primary outcome timeframe

Baseline

Results posted on

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

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

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

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: Baseline

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

Outcome measures

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Group II

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Group III

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Group A

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Group B

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Group C

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sarah Dassati

Villa Melitta

Phone: +39 0471 471

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place