Trial Outcomes & Findings for Efficacy and Safety of Plasma Exchange With 5% Albumin in Beta-amyloid Peptide Clearance in Cerebral Spinal Fluid (NCT NCT00742417)
NCT ID: NCT00742417
Last Updated: 2016-06-14
Results Overview
Change in levels of Aβ1-42 in CSF in the period between baseline lumbar puncture (before the start of treatment) and lumbar puncture immediately after the end of the last plasma exchange (whenever this may be). Separate assays of Aβ1-42 were performed with Innotest and The Genetics Company commercial kits.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
Baseline and up to week 44
Results posted on
2016-06-14
Participant Flow
Participant milestones
| Measure |
Albutein 5%
18 Plasma Exchanges using Albutein 5%:
* three weeks of intensive treatment with two plasma exchanges per week
* six weeks of maintenance treatment with one weekly plasma exchange
* three months of maintenance treatment with one plasma exchange every two weeks
|
Control (Sham Procedure)
Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
|
|---|---|---|
|
Randomized
STARTED
|
21
|
21
|
|
Randomized
COMPLETED
|
19
|
20
|
|
Randomized
NOT COMPLETED
|
2
|
1
|
|
Intensive Period
STARTED
|
19
|
20
|
|
Intensive Period
COMPLETED
|
16
|
19
|
|
Intensive Period
NOT COMPLETED
|
3
|
1
|
|
Maintenance I
STARTED
|
16
|
19
|
|
Maintenance I
COMPLETED
|
16
|
19
|
|
Maintenance I
NOT COMPLETED
|
0
|
0
|
|
Maintenance II
STARTED
|
16
|
19
|
|
Maintenance II
COMPLETED
|
16
|
19
|
|
Maintenance II
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Albutein 5%
18 Plasma Exchanges using Albutein 5%:
* three weeks of intensive treatment with two plasma exchanges per week
* six weeks of maintenance treatment with one weekly plasma exchange
* three months of maintenance treatment with one plasma exchange every two weeks
|
Control (Sham Procedure)
Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
|
|---|---|---|
|
Randomized
Withdrawal by legal representative
|
0
|
1
|
|
Randomized
Withdrawal by Subject
|
1
|
0
|
|
Randomized
Physician Decision
|
1
|
0
|
|
Intensive Period
Withdrawal by Subject
|
1
|
1
|
|
Intensive Period
Adverse Event
|
2
|
0
|
Baseline Characteristics
Efficacy and Safety of Plasma Exchange With 5% Albumin in Beta-amyloid Peptide Clearance in Cerebral Spinal Fluid
Baseline characteristics by cohort
| Measure |
Albutein 5%
n=19 Participants
18 Plasma Exchanges using Albutein 5%:
* three weeks of intensive treatment with two plasma exchanges per week
* six weeks of maintenance treatment with one weekly plasma exchange
* three months of maintenance treatment with one plasma exchange every two weeks
|
Control
n=20 Participants
Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
|
Total
n=39 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
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Weight
|
64.0 Kg
STANDARD_DEVIATION 14.5 • n=5 Participants
|
66.0 Kg
STANDARD_DEVIATION 16.6 • n=7 Participants
|
65.1 Kg
STANDARD_DEVIATION 15.5 • n=5 Participants
|
|
Height
|
156.8 cm
STANDARD_DEVIATION 11.2 • n=5 Participants
|
159.3 cm
STANDARD_DEVIATION 9.4 • n=7 Participants
|
158.3 cm
STANDARD_DEVIATION 10.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and up to week 44Population: The efficacy analyses were performed with the full analysis set (FAS) population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions (or sham procedures) during the intensive treatment phase (the three first weeks of treatment).
Change in levels of Aβ1-42 in CSF in the period between baseline lumbar puncture (before the start of treatment) and lumbar puncture immediately after the end of the last plasma exchange (whenever this may be). Separate assays of Aβ1-42 were performed with Innotest and The Genetics Company commercial kits.
Outcome measures
| Measure |
Albutein 5%
n=18 Participants
18 Plasma Exchanges using Albutein 5%:
* three weeks of intensive treatment with two plasma exchanges per week
* six weeks of maintenance treatment with one weekly plasma exchange
* three months of maintenance treatment with one plasma exchange every two weeks
|
Control (Sham Procedure)
n=19 Participants
Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
|
|---|---|---|
|
Change From Baseline in Aβ1-42 Cerebrospinal Fluid (CSF) Levels.
Aβ1-42 Innotest
|
75.3 pg/mL
Interval -20.0 to 170.5
|
-45.5 pg/mL
Interval -135.1 to 44.2
|
|
Change From Baseline in Aβ1-42 Cerebrospinal Fluid (CSF) Levels.
Aβ1-42 The Genetics Company
|
-86.2 pg/mL
Interval -253.9 to 81.5
|
-283.0 pg/mL
Interval -441.1 to -125.0
|
SECONDARY outcome
Timeframe: Baseline, week 02, week 08, week 20, week 33 and week 44Population: The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).
Levels of Tau and P-tau in CSF throughout the treatment phase and the follow-up phase (week 44).
Outcome measures
| Measure |
Albutein 5%
n=18 Participants
18 Plasma Exchanges using Albutein 5%:
* three weeks of intensive treatment with two plasma exchanges per week
* six weeks of maintenance treatment with one weekly plasma exchange
* three months of maintenance treatment with one plasma exchange every two weeks
|
Control (Sham Procedure)
n=19 Participants
Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
|
|---|---|---|
|
P-Tau and Tau CSF Levels Throughout the Study.
P-Tau (baseline) (Albutein n=18; Control n=19)
|
87.7 pg/mL
Standard Deviation 51.4
|
79.0 pg/mL
Standard Deviation 35.1
|
|
P-Tau and Tau CSF Levels Throughout the Study.
P-Tau (week 02) (n=16; n=19)
|
87.5 pg/mL
Standard Deviation 43.8
|
94.1 pg/mL
Standard Deviation 46.7
|
|
P-Tau and Tau CSF Levels Throughout the Study.
P-Tau (week 08) (n=15; n=18)
|
78.9 pg/mL
Standard Deviation 46.3
|
78.0 pg/mL
Standard Deviation 41.3
|
|
P-Tau and Tau CSF Levels Throughout the Study.
P-Tau (week 20) (n=15; n=18)
|
88.4 pg/mL
Standard Deviation 42.0
|
84.1 pg/mL
Standard Deviation 36.8
|
|
P-Tau and Tau CSF Levels Throughout the Study.
P-Tau (week 33) (n=14; n=15)
|
91.9 pg/mL
Standard Deviation 57.6
|
78.7 pg/mL
Standard Deviation 40.4
|
|
P-Tau and Tau CSF Levels Throughout the Study.
P-Tau (week 44) (n=14; n=14)
|
89.9 pg/mL
Standard Deviation 54.5
|
85.1 pg/mL
Standard Deviation 46.5
|
|
P-Tau and Tau CSF Levels Throughout the Study.
Tau (baseline) (n=18; n=19)
|
571.2 pg/mL
Standard Deviation 354.4
|
589.6 pg/mL
Standard Deviation 344.2
|
|
P-Tau and Tau CSF Levels Throughout the Study.
Tau (week 02) (n=16; n=19)
|
669.8 pg/mL
Standard Deviation 496.8
|
711.0 pg/mL
Standard Deviation 388.8
|
|
P-Tau and Tau CSF Levels Throughout the Study.
Tau (week 08) (n=15; n=18)
|
482.2 pg/mL
Standard Deviation 307.4
|
526.3 pg/mL
Standard Deviation 326.9
|
|
P-Tau and Tau CSF Levels Throughout the Study.
Tau (week 20) (n=15; n=18)
|
537.1 pg/mL
Standard Deviation 253.5
|
555.6 pg/mL
Standard Deviation 308.3
|
|
P-Tau and Tau CSF Levels Throughout the Study.
Tau (week 33) (n=14; n=15)
|
539.5 pg/mL
Standard Deviation 309.6
|
483.5 pg/mL
Standard Deviation 318.5
|
|
P-Tau and Tau CSF Levels Throughout the Study.
Tau (week 44) (n=14; n=14)
|
544.3 pg/mL
Standard Deviation 299.4
|
544.1 pg/mL
Standard Deviation 347.4
|
SECONDARY outcome
Timeframe: Baseline, pre-plasma exchange 1 (PRE-PE1), post-plasma exchange 6 (POST-PE6), pre-plasma exchange 7 (PRE-PE7), post-plasma exchange 12 (POST-PE12), pre-plasma exchange 13 (PRE-PE13), post-plasma exchange 18 (POST-PE18), week 33 and week 44.Population: The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).
Plasma levels of Aβ1-40 before and after the Intensive period, Maintenance period I, Maintenance period II and the Follow-up phase (using The Genetics Company commercial kits).
Outcome measures
| Measure |
Albutein 5%
n=18 Participants
18 Plasma Exchanges using Albutein 5%:
* three weeks of intensive treatment with two plasma exchanges per week
* six weeks of maintenance treatment with one weekly plasma exchange
* three months of maintenance treatment with one plasma exchange every two weeks
|
Control (Sham Procedure)
n=19 Participants
Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
|
|---|---|---|
|
Aβ1-40 Plasma Levels Before and After Each Study Period (The Genetics Company).
Aβ1-40 Baseline (Albutein n=18; Control n=18)
|
121.3 pg/mL
Standard Deviation 52.6
|
126.7 pg/mL
Standard Deviation 43.2
|
|
Aβ1-40 Plasma Levels Before and After Each Study Period (The Genetics Company).
Aβ1-40 PRE-PE1 (Intensive) (n=18; n=19)
|
120.3 pg/mL
Standard Deviation 57.1
|
105.8 pg/mL
Standard Deviation 47.7
|
|
Aβ1-40 Plasma Levels Before and After Each Study Period (The Genetics Company).
Aβ1-40 POST-PE6 (Intensive) (n=15; n=19)
|
255.7 pg/mL
Standard Deviation 98.4
|
123.9 pg/mL
Standard Deviation 53.7
|
|
Aβ1-40 Plasma Levels Before and After Each Study Period (The Genetics Company).
Aβ1-40 PRE-PE7(Maintenance I) (n=14; n=17)
|
150.7 pg/mL
Standard Deviation 51.3
|
139.7 pg/mL
Standard Deviation 41.8
|
|
Aβ1-40 Plasma Levels Before and After Each Study Period (The Genetics Company).
Aβ1-40 POST-PE12 (Maintenance I) (n=14; n=18)
|
287.1 pg/mL
Standard Deviation 98.6
|
150.4 pg/mL
Standard Deviation 54.4
|
|
Aβ1-40 Plasma Levels Before and After Each Study Period (The Genetics Company).
Aβ1-40 PRE-PE13 (Maintenance II) (n=15; n=19)
|
150.0 pg/mL
Standard Deviation 66.0
|
129.6 pg/mL
Standard Deviation 40.3
|
|
Aβ1-40 Plasma Levels Before and After Each Study Period (The Genetics Company).
Aβ1-40 POST-PE18 (Maintenance II) (n=14; n=18)
|
245.9 pg/mL
Standard Deviation 102.0
|
135.4 pg/mL
Standard Deviation 50.2
|
|
Aβ1-40 Plasma Levels Before and After Each Study Period (The Genetics Company).
Follow up (33 week) (n=14; n=15)
|
153.3 pg/mL
Standard Deviation 50.6
|
136.9 pg/mL
Standard Deviation 37.3
|
|
Aβ1-40 Plasma Levels Before and After Each Study Period (The Genetics Company).
Follow up (44 week) (n=15; n=14)
|
146.7 pg/mL
Standard Deviation 41.7
|
147.1 pg/mL
Standard Deviation 23.4
|
SECONDARY outcome
Timeframe: Baseline, pre-plasma exchange 1 (PRE-PE1), post-plasma exchange 6 (POST-PE6), pre-plasma exchange 7 (PRE-PE7), post-plasma exchange 12 (POST-PE12), pre-plasma exchange 13 (PRE-PE13), post-plasma exchange 18 (POST-PE18), week 33 and week 44Population: The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).
Plasma levels of Aβ1-42 before and after the Intensive period, Maintenance period I, Maintenance period II and the Follow-up phase (using The Genetics Company commercial kits).
Outcome measures
| Measure |
Albutein 5%
n=18 Participants
18 Plasma Exchanges using Albutein 5%:
* three weeks of intensive treatment with two plasma exchanges per week
* six weeks of maintenance treatment with one weekly plasma exchange
* three months of maintenance treatment with one plasma exchange every two weeks
|
Control (Sham Procedure)
n=19 Participants
Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
|
|---|---|---|
|
Aβ1-42 Plasma Levels Before and After Each Study Period (The Genetics Company).
Aβ1-42 Baseline (Albutein n=18; Control n=18)
|
2.8 pg/mL
Standard Deviation 9.3
|
33.7 pg/mL
Standard Deviation 81.4
|
|
Aβ1-42 Plasma Levels Before and After Each Study Period (The Genetics Company).
Aβ1-42 PRE-PE1 (Intensive) (n=18; n=19)
|
6.6 pg/mL
Standard Deviation 16.3
|
20.9 pg/mL
Standard Deviation 58.4
|
|
Aβ1-42 Plasma Levels Before and After Each Study Period (The Genetics Company).
Aβ1-42 POST-PE6 (Intensive) (n=15; n=19)
|
9.8 pg/mL
Standard Deviation 15.6
|
4.9 pg/mL
Standard Deviation 11.8
|
|
Aβ1-42 Plasma Levels Before and After Each Study Period (The Genetics Company).
Aβ1-42 PRE-PE7 (Maintenance) (n=14; n=17)
|
0.0 pg/mL
Standard Deviation 0.0
|
4.5 pg/mL
Standard Deviation 12.9
|
|
Aβ1-42 Plasma Levels Before and After Each Study Period (The Genetics Company).
Aβ1-42 POST-PE12 (Maintenance I) (n=14; n=18)
|
10.7 pg/mL
Standard Deviation 15.9
|
5.9 pg/mL
Standard Deviation 14.3
|
|
Aβ1-42 Plasma Levels Before and After Each Study Period (The Genetics Company).
Aβ1-42 PRE-PE13 (Maintenance II) (n=15; n=19)
|
6.9 pg/mL
Standard Deviation 11.8
|
8.2 pg/mL
Standard Deviation 17.2
|
|
Aβ1-42 Plasma Levels Before and After Each Study Period (The Genetics Company).
Aβ1-42 POST-PE18 (Maintenance II) (n=14; n=18)
|
8.0 pg/mL
Standard Deviation 16.7
|
7.1 pg/mL
Standard Deviation 14.3
|
|
Aβ1-42 Plasma Levels Before and After Each Study Period (The Genetics Company).
Follow up (44 week) (n=15; n=14)
|
1.7 pg/mL
Standard Deviation 6.6
|
10.2 pg/mL
Standard Deviation 18.2
|
SECONDARY outcome
Timeframe: Baseline, pre-plasma exchange 1 (PRE-PE1), post-plasma exchange 6 (POST-PE6), pre-plasma exchange 7 (PRE-PE7), post-plasma exchange 12 (POST-PE12), pre-plasma exchange 13 (PRE-PE13), post-plasma exchange 18 (POST-PE18), week 33 and week 44.Population: The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).
Plasma levels of Aβ1-42 before and after the Intensive period, Maintenance period I, Maintenance period II and the Follow-up phase (using Innotest commercial kits).
Outcome measures
| Measure |
Albutein 5%
n=18 Participants
18 Plasma Exchanges using Albutein 5%:
* three weeks of intensive treatment with two plasma exchanges per week
* six weeks of maintenance treatment with one weekly plasma exchange
* three months of maintenance treatment with one plasma exchange every two weeks
|
Control (Sham Procedure)
n=19 Participants
Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
|
|---|---|---|
|
Aβ1-42 Plasma Levels Before and After Each Study Period (Innotest).
Aβ1-42 Baseline (Albutein n=18; Control n=18)
|
40.1 pg/mL
Standard Deviation 77.1
|
49.5 pg/mL
Standard Deviation 43.7
|
|
Aβ1-42 Plasma Levels Before and After Each Study Period (Innotest).
Aβ1-42 PRE-PE1 (Intensive) (n=18; n=19)
|
20.4 pg/mL
Standard Deviation 21.5
|
33.4 pg/mL
Standard Deviation 29.1
|
|
Aβ1-42 Plasma Levels Before and After Each Study Period (Innotest).
Aβ1-42 POST-PE6 (Intensive) (n=15; n=19)
|
29.1 pg/mL
Standard Deviation 23.2
|
45.4 pg/mL
Standard Deviation 31.3
|
|
Aβ1-42 Plasma Levels Before and After Each Study Period (Innotest).
Aβ1-42 PRE-PE7 (Maintenance I) (n=14; n=17)
|
29.5 pg/mL
Standard Deviation 30.9
|
58.5 pg/mL
Standard Deviation 68.1
|
|
Aβ1-42 Plasma Levels Before and After Each Study Period (Innotest).
Aβ1-42 POST-PE12 (Maintenance I) (n=14; n=18)
|
25.1 pg/mL
Standard Deviation 21.0
|
41.4 pg/mL
Standard Deviation 35.5
|
|
Aβ1-42 Plasma Levels Before and After Each Study Period (Innotest).
Aβ1-42 PRE-PE13 (Maintenance II) (n=15; n=19)
|
36.4 pg/mL
Standard Deviation 35.9
|
51.2 pg/mL
Standard Deviation 48.3
|
|
Aβ1-42 Plasma Levels Before and After Each Study Period (Innotest).
Aβ1-42 POST-PE18 (Maintenance II) (n=14; n=18)
|
37.1 pg/mL
Standard Deviation 40.9
|
45.3 pg/mL
Standard Deviation 42.4
|
|
Aβ1-42 Plasma Levels Before and After Each Study Period (Innotest).
Follow up (33 week) (n=14; n=15)
|
10.1 pg/mL
Standard Deviation 12.9
|
10.2 pg/mL
Standard Deviation 16.7
|
|
Aβ1-42 Plasma Levels Before and After Each Study Period (Innotest).
Follow up (44 week) (n=15; n=14)
|
11.3 pg/mL
Standard Deviation 11.4
|
11.7 pg/mL
Standard Deviation 20.8
|
SECONDARY outcome
Timeframe: Change from baseline at week 44Population: The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).
Change in the cognitive, functional and neuropsychiatric scores and overall development. * MMSE: Mini Mental State Examination Score (range = 0 to 30, with lower values indicating impairment) * ADAS-Cog: Alzheimer's Disease Assessment Scale, Cognitive Subscale (range = 0 to 70, with higher values indicating impairment) * NPS (Neuropsychological battery): •SDMT (Symbol Digit Modalities Test, range = 0 to 110, with lower values indicating impairment), •SVF (Semantic Verbal Fluency Test, with a maximum of 44 words in 60 seconds), •PVF F, A and S (Phonetic Verbal Fluency Test, with a maximum of 44 words in 60 seconds), •BNT (Boston Naming Test, with a maximum of 15 pictures), •RAVLT (Rey Auditory Verbal Learning Test, with 15 words the patient should listen and remind) * CSDD (Cornell Scale for Depression in Dementia, 0 = none; 1 =mild or intermittent; 2 = severe)
Outcome measures
| Measure |
Albutein 5%
n=18 Participants
18 Plasma Exchanges using Albutein 5%:
* three weeks of intensive treatment with two plasma exchanges per week
* six weeks of maintenance treatment with one weekly plasma exchange
* three months of maintenance treatment with one plasma exchange every two weeks
|
Control (Sham Procedure)
n=19 Participants
Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
|
|---|---|---|
|
Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (MMSE, ADAS-Cog, NPS Battery and CSDD)
MMSE (Albutein n=15; Control n=14)
|
-1.7 units on a scale
Standard Deviation 3.2
|
-3.8 units on a scale
Standard Deviation 5.9
|
|
Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (MMSE, ADAS-Cog, NPS Battery and CSDD)
ADAS-Cog (n=15; n=14)
|
3.9 units on a scale
Standard Deviation 6.2
|
6.6 units on a scale
Standard Deviation 10.5
|
|
Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (MMSE, ADAS-Cog, NPS Battery and CSDD)
NPS (SDMT) (n=15; n=14)
|
1.3 units on a scale
Standard Deviation 11.2
|
-0.5 units on a scale
Standard Deviation 2.5
|
|
Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (MMSE, ADAS-Cog, NPS Battery and CSDD)
NPS (SVF) (n=15; n=14) (n=15; n=14)
|
2.5 units on a scale
Standard Deviation 3.2
|
-0.4 units on a scale
Standard Deviation 3.8
|
|
Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (MMSE, ADAS-Cog, NPS Battery and CSDD)
NPS (PVF(F)) (n=15; n=14)
|
-0.2 units on a scale
Standard Deviation 2.6
|
0.6 units on a scale
Standard Deviation 3.8
|
|
Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (MMSE, ADAS-Cog, NPS Battery and CSDD)
NPS (PVF(A)) (n=15; n=14)
|
0.2 units on a scale
Standard Deviation 3.4
|
0.2 units on a scale
Standard Deviation 3.2
|
|
Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (MMSE, ADAS-Cog, NPS Battery and CSDD)
NPS (PVF(S)) (n=15; n=14)
|
1.1 units on a scale
Standard Deviation 1.8
|
-0.6 units on a scale
Standard Deviation 3.3
|
|
Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (MMSE, ADAS-Cog, NPS Battery and CSDD)
NPS (BNT) (n=15; n=14)
|
1.7 units on a scale
Standard Deviation 2.5
|
0.3 units on a scale
Standard Deviation 4.1
|
|
Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (MMSE, ADAS-Cog, NPS Battery and CSDD)
NPS (RAVLT Intermediate 1) (n=15; n=14)
|
1.1 units on a scale
Standard Deviation 1.9
|
-0.1 units on a scale
Standard Deviation 2.0
|
|
Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (MMSE, ADAS-Cog, NPS Battery and CSDD)
NPS (RAVLT Intermediate 2) (n=15; n=14)
|
0.3 units on a scale
Standard Deviation 1.6
|
-1.0 units on a scale
Standard Deviation 1.5
|
|
Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (MMSE, ADAS-Cog, NPS Battery and CSDD)
NPS (RAVLT Intermediate 3) (n=15; n=14)
|
0.1 units on a scale
Standard Deviation 2.1
|
-0.3 units on a scale
Standard Deviation 2.0
|
|
Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (MMSE, ADAS-Cog, NPS Battery and CSDD)
NPS (RAVLT Intermediate 4) (n=15; n=14)
|
-1.1 units on a scale
Standard Deviation 1.8
|
-0.9 units on a scale
Standard Deviation 2.5
|
|
Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (MMSE, ADAS-Cog, NPS Battery and CSDD)
NPS (RAVLT Intermediate 5) (n=15; n=14)
|
-0.3 units on a scale
Standard Deviation 2.1
|
-1.4 units on a scale
Standard Deviation 1.8
|
|
Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (MMSE, ADAS-Cog, NPS Battery and CSDD)
NPS (RAVLT Delayed) (n=15; n=14)
|
0.5 units on a scale
Standard Deviation 1.6
|
0.1 units on a scale
Standard Deviation 1.0
|
|
Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (MMSE, ADAS-Cog, NPS Battery and CSDD)
CSDD (patient) (n=10; n=7)
|
-0.8 units on a scale
Standard Deviation 2.9
|
-2.1 units on a scale
Standard Deviation 5.6
|
|
Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (MMSE, ADAS-Cog, NPS Battery and CSDD)
CSDD (caregiver) (n=13; n=11)
|
1.0 units on a scale
Standard Deviation 4.1
|
1.8 units on a scale
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Change from baseline at week 44Population: The efficacy analyses were performed with the FAS population which was defined as the set of subjects who were randomized, and received at least three plasma exchange sessions during the intensive treatment phase (the three first weeks of treatment).
Change in the cognitive, functional and neuropsychiatric scores and overall development. * ADCS-ADL: Alzheimer's Disease Cooperative Study/Activities Of Daily Living (23 questions describing daily activity of the subject and requests the informer to describe the actions or behaviors observed. Increased autonomy associated to higher scores, maximum of 78 points and minimum of 0) * NPI: Neuropsychiatric Inventory Questions (12 symptom domains scored by frequency \[range=0 to 4, higher values being more frequent\] and severity \[range=1 to 3, higher values being more severe\], total score is sum of frequency x severity of all domains) * CDR-Sb: Clinical Dementia Rating (range=0 to 3, higher values being more severe) * ADCS-CGIC: Alzheimer's Disease Cooperative Study/Clinical Global Impression of Change (7-point Likert scale, 0=not assessed, 1=marked improvement, 2=moderate improvement, 3=minimal improvement, 4=no change, 5=minimal worsening, 6=moderate worsening and 7=marked worsening)
Outcome measures
| Measure |
Albutein 5%
n=18 Participants
18 Plasma Exchanges using Albutein 5%:
* three weeks of intensive treatment with two plasma exchanges per week
* six weeks of maintenance treatment with one weekly plasma exchange
* three months of maintenance treatment with one plasma exchange every two weeks
|
Control (Sham Procedure)
n=19 Participants
Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
|
|---|---|---|
|
Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (ADCS-ADL, NPI, CDR-Sb and ADCS-CGIC).
ADCS-ADL (Albutein n=15; Control n=14)
|
-7.1 units on a scale
Standard Deviation 11.4
|
-4.9 units on a scale
Standard Deviation 10.9
|
|
Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (ADCS-ADL, NPI, CDR-Sb and ADCS-CGIC).
NPI (total score) (n=15; n=14)
|
-1.7 units on a scale
Standard Deviation 14.1
|
-4.0 units on a scale
Standard Deviation 13.7
|
|
Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (ADCS-ADL, NPI, CDR-Sb and ADCS-CGIC).
NPI (total distress) (n=15; n=14)
|
-2.1 units on a scale
Standard Deviation 7.8
|
-3.6 units on a scale
Standard Deviation 6.4
|
|
Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (ADCS-ADL, NPI, CDR-Sb and ADCS-CGIC).
CDR Sb score (n=15; n=14)
|
1.7 units on a scale
Standard Deviation 1.5
|
1.4 units on a scale
Standard Deviation 3.3
|
|
Change From Baseline to Week 44 in Cognitive, Functional and Neuropsychiatric Scores (ADCS-ADL, NPI, CDR-Sb and ADCS-CGIC).
ADCS-CGIC (n=15; n=14)
|
1.5 units on a scale
Standard Deviation 0.7
|
1.2 units on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Week 00 (baseline), week 20 and week 44Population: We analyzed two groups of patients, a treatment group of 20 patients, and a control group, also of 20 patients
Structural changes in volume of the hippocampus, posterior cingular area, and other associated areas by Magnetic Resonance Imaging (MRI). Three measurements were made (week -2 or -1, 20 and 44). It was measured the variations versus the baseline.
Outcome measures
| Measure |
Albutein 5%
n=20 Participants
18 Plasma Exchanges using Albutein 5%:
* three weeks of intensive treatment with two plasma exchanges per week
* six weeks of maintenance treatment with one weekly plasma exchange
* three months of maintenance treatment with one plasma exchange every two weeks
|
Control (Sham Procedure)
n=20 Participants
Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
|
|---|---|---|
|
Magnetic Resonance Imaging (MRI) Structural Changes Variations Versus Baseline.
Post Cingulate (week 44)
|
10.60 cubic centimetres (cc)
Standard Deviation 1.48
|
10.23 cubic centimetres (cc)
Standard Deviation 1.06
|
|
Magnetic Resonance Imaging (MRI) Structural Changes Variations Versus Baseline.
Total Intracranial Volume (week 00)
|
1034.38 cubic centimetres (cc)
Standard Deviation 99.77
|
1064.38 cubic centimetres (cc)
Standard Deviation 130.29
|
|
Magnetic Resonance Imaging (MRI) Structural Changes Variations Versus Baseline.
Total Intracranial Volume (week 20)
|
990.31 cubic centimetres (cc)
Standard Deviation 83.42
|
1042.70 cubic centimetres (cc)
Standard Deviation 119.93
|
|
Magnetic Resonance Imaging (MRI) Structural Changes Variations Versus Baseline.
Total Intracranial Volume (week 44)
|
985.43 cubic centimetres (cc)
Standard Deviation 86.10
|
1026.51 cubic centimetres (cc)
Standard Deviation 148.43
|
|
Magnetic Resonance Imaging (MRI) Structural Changes Variations Versus Baseline.
Hippocampus L (week 00)
|
1.90 cubic centimetres (cc)
Standard Deviation 0.41
|
1.91 cubic centimetres (cc)
Standard Deviation 0.48
|
|
Magnetic Resonance Imaging (MRI) Structural Changes Variations Versus Baseline.
Hippocampus L (week 20)
|
1.76 cubic centimetres (cc)
Standard Deviation 0.45
|
1.85 cubic centimetres (cc)
Standard Deviation 0.40
|
|
Magnetic Resonance Imaging (MRI) Structural Changes Variations Versus Baseline.
Hippocampus L (week 44)
|
1.64 cubic centimetres (cc)
Standard Deviation 0.43
|
1.76 cubic centimetres (cc)
Standard Deviation 0.39
|
|
Magnetic Resonance Imaging (MRI) Structural Changes Variations Versus Baseline.
Hippocampus R (week 00)
|
2.04 cubic centimetres (cc)
Standard Deviation 0.41
|
2.14 cubic centimetres (cc)
Standard Deviation 0.38
|
|
Magnetic Resonance Imaging (MRI) Structural Changes Variations Versus Baseline.
Hippocampus R (week 20)
|
1.98 cubic centimetres (cc)
Standard Deviation 0.41
|
2.07 cubic centimetres (cc)
Standard Deviation 0.32
|
|
Magnetic Resonance Imaging (MRI) Structural Changes Variations Versus Baseline.
Hippocampus R (week 44)
|
1.88 cubic centimetres (cc)
Standard Deviation 0.35
|
1.96 cubic centimetres (cc)
Standard Deviation 0.34
|
|
Magnetic Resonance Imaging (MRI) Structural Changes Variations Versus Baseline.
Post Cingulate (week 00)
|
10.60 cubic centimetres (cc)
Standard Deviation 1.34
|
10.38 cubic centimetres (cc)
Standard Deviation 0.80
|
|
Magnetic Resonance Imaging (MRI) Structural Changes Variations Versus Baseline.
Post Cingulate (week 20)
|
10.22 cubic centimetres (cc)
Standard Deviation 1.58
|
10.39 cubic centimetres (cc)
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: End of studyPopulation: We analyzed two groups of patients, a treatment group of 20 patients, and a control group, also of 20 patients
Percentage of patients with improved perfusion at the end of the study compared to their initial perfusion. Frontal, parietal and temporal lobes were evaluated from the quantified NeuroGam images. This rendered parametric images showed brain alterations with more than 2 standard deviations with respect to a normal data base. Initial parametric images were compared to the final ones and it was considered perfusion improvement those patients that showed less stretch and/or defect intensity.
Outcome measures
| Measure |
Albutein 5%
n=20 Participants
18 Plasma Exchanges using Albutein 5%:
* three weeks of intensive treatment with two plasma exchanges per week
* six weeks of maintenance treatment with one weekly plasma exchange
* three months of maintenance treatment with one plasma exchange every two weeks
|
Control (Sham Procedure)
n=20 Participants
Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
|
|---|---|---|
|
Variations in Hypoperfusion Based on Single Photon Emission Computed Tomography (SPECT)
Parietal
|
25 percentage of participants
|
20 percentage of participants
|
|
Variations in Hypoperfusion Based on Single Photon Emission Computed Tomography (SPECT)
Temporal
|
25 percentage of participants
|
10 percentage of participants
|
|
Variations in Hypoperfusion Based on Single Photon Emission Computed Tomography (SPECT)
Frontal
|
5 percentage of participants
|
5 percentage of participants
|
Adverse Events
Albutein 5%
Serious events: 3 serious events
Other events: 18 other events
Deaths: 0 deaths
Control (Sham Procedure)
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Albutein 5%
n=19 participants at risk
18 Plasma Exchanges using Albutein 5%:
* three weeks of intensive treatment with two plasma exchanges per week
* six weeks of maintenance treatment with one weekly plasma exchange
* three months of maintenance treatment with one plasma exchange every two weeks
|
Control (Sham Procedure)
n=20 participants at risk
Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
|
|---|---|---|
|
General disorders
Medical device complication
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
0.00%
0/20 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/19 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
5.0%
1/20 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Infections and infestations
Otitis media
|
0.00%
0/19 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
5.0%
1/20 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Nervous system disorders
Loss of conscieousness
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
0.00%
0/20 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Nervous system disorders
Partial seizures
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
0.00%
0/20 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
Other adverse events
| Measure |
Albutein 5%
n=19 participants at risk
18 Plasma Exchanges using Albutein 5%:
* three weeks of intensive treatment with two plasma exchanges per week
* six weeks of maintenance treatment with one weekly plasma exchange
* three months of maintenance treatment with one plasma exchange every two weeks
|
Control (Sham Procedure)
n=20 participants at risk
Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements)
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
36.8%
7/19 • Number of events 7 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
10.0%
2/20 • Number of events 2 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Eye disorders
Ocular hypertension
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
0.00%
0/20 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
10.0%
2/20 • Number of events 2 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
General disorders
Asthenia
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
0.00%
0/20 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
General disorders
Catheter site haemorrage
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
0.00%
0/20 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
General disorders
Fatigue
|
10.5%
2/19 • Number of events 2 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
0.00%
0/20 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
General disorders
Pyrexia
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
5.0%
1/20 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Infections and infestations
Bronchitis
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
0.00%
0/20 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Infections and infestations
Device related infection
|
26.3%
5/19 • Number of events 5 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
5.0%
1/20 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Infections and infestations
Nasopharyngitis
|
10.5%
2/19 • Number of events 2 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
5.0%
1/20 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Infections and infestations
Respiratory tract infection
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
0.00%
0/20 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
0.00%
0/20 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Infections and infestations
Urinary tract infection
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
0.00%
0/20 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Injury, poisoning and procedural complications
Fall
|
10.5%
2/19 • Number of events 2 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
10.0%
2/20 • Number of events 2 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
0.00%
0/20 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Investigations
Weight decreased
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
0.00%
0/20 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
0.00%
0/20 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
0.00%
0/20 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
10.0%
2/20 • Number of events 2 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrage
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
0.00%
0/20 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
0.00%
0/20 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
0.00%
0/20 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
0.00%
0/20 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Nervous system disorders
Dizziness
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
0.00%
0/20 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Psychiatric disorders
Aggression
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
5.0%
1/20 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Psychiatric disorders
Anxiety
|
21.1%
4/19 • Number of events 4 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
10.0%
2/20 • Number of events 2 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Psychiatric disorders
Confusion state
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
0.00%
0/20 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Psychiatric disorders
Delirium
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
0.00%
0/20 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Psychiatric disorders
Depression
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
0.00%
0/20 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Psychiatric disorders
Depressive symptom
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
0.00%
0/20 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Psychiatric disorders
Disinhibition
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
0.00%
0/20 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Psychiatric disorders
Insomnia
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
0.00%
0/20 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
0.00%
0/20 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Skin and subcutaneous tissue disorders
Photosensivity reaction
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
0.00%
0/20 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Surgical and medical procedures
Bunion operation
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
0.00%
0/20 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Surgical and medical procedures
Urinary cistectomy
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
0.00%
0/20 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Vascular disorders
Hypertension
|
0.00%
0/19 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
10.0%
2/20 • Number of events 2 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
0.00%
0/20 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19 • Number of events 1 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
0.00%
0/20 • Primary criterion of safety was % of plasma exchange (PE) associated with at least one adverse event (AE) that may be related to the study procedure (adverse reaction).
In addition, global consideration will be made of the percentage PE involving some AE, whether or not related to the procedure. Vital signs, anxiety and restlessness tests and the criterion of the investigator were also used to evaluate patient safety.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators are free to publish the results after signing the final report. When several papers are published, each one will be mainly prepared by the more experienced investigator who will appear as first author. The rest of co-authors will appear in the order considered opportune by the principal investigator. Sponsor will receive a copy of the manuscript for review at least 30 days prior to submission for publication or presentation of the abstract at some scientific meeting.
- Publication restrictions are in place
Restriction type: OTHER