Trial Outcomes & Findings for Efficacy and Safety of Filgrastim in Alzheimer's Disease (NCT NCT01617577)
NCT ID: NCT01617577
Last Updated: 2012-12-27
Results Overview
Scores from each of the cognitive assessments: mean ADAScog: a decrease in total score units = improvement, min=0 max=31 mean PAL (memory): an increase in score = improvement, min= 0 max=12 mean PAL (total trial adj): a decrease in score = improvement,
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
8 participants
Primary outcome timeframe
Baseline and 2wk and 4 wk after Rx;
Results posted on
2012-12-27
Participant Flow
Participant milestones
| Measure |
G-CSF First Phase
Subjects assigned to this arm receive G-CSF for 5 days during the first phase of the study. At week 7 these subjects cross over to receive placebo injections for five days
|
Placebo First Phase
Subjects assigned to this arm receive placebo injections daily for 5 days; after wk 7 they crossover to receive 5 daily injections of injections of G-CSF.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
3
|
|
Overall Study
COMPLETED
|
5
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Filgrastim in Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Placebo First Phase
n=3 Participants
Subjects assigned to this arm receive placebo injections daily for 5 days; after wk 7 they crossover to receive 5 daily injections of injections of G-CSF.
|
Total
n=8 Participants
Total of all reporting groups
|
G-CSF First Phase
n=5 Participants
Subjects assigned to this arm receive G-CSF for 5 days during the first phase of the study. At week 7 these subjects cross over to receive placebo injections for five days
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
|
Age Continuous
|
75.2 years
STANDARD_DEVIATION 3.1 • n=7 Participants
|
72.3 years
STANDARD_DEVIATION 2.9 • n=5 Participants
|
71.6 years
STANDARD_DEVIATION 3.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 2wk and 4 wk after Rx;Scores from each of the cognitive assessments: mean ADAScog: a decrease in total score units = improvement, min=0 max=31 mean PAL (memory): an increase in score = improvement, min= 0 max=12 mean PAL (total trial adj): a decrease in score = improvement,
Outcome measures
| Measure |
G-CSF
n=8 Participants
All participants received G-CSF either in the first or second phase of the crossover
|
Placebo
n=8 Participants
All participants received placebo either in the first or second phase of crossover
|
|---|---|---|
|
Cognitive Measures Incluing ADAScog, Selected CANTABS Tests (Paired Associate Learning (PAL)and PAL )
ADAScog Baseline
|
22.25 units on a scale
Standard Error 2.49
|
22.25 units on a scale
Standard Error 2.49
|
|
Cognitive Measures Incluing ADAScog, Selected CANTABS Tests (Paired Associate Learning (PAL)and PAL )
ADAScog 2wk post Rx
|
20.5 units on a scale
Standard Error 1.67
|
17.75 units on a scale
Standard Error 2.67
|
|
Cognitive Measures Incluing ADAScog, Selected CANTABS Tests (Paired Associate Learning (PAL)and PAL )
ADAScog 4wks post Rx
|
21.5 units on a scale
Standard Error 2.507
|
20.125 units on a scale
Standard Error 2.14
|
|
Cognitive Measures Incluing ADAScog, Selected CANTABS Tests (Paired Associate Learning (PAL)and PAL )
PALmem baseline
|
2.75 units on a scale
Standard Error 0.59
|
2.75 units on a scale
Standard Error 0.59
|
|
Cognitive Measures Incluing ADAScog, Selected CANTABS Tests (Paired Associate Learning (PAL)and PAL )
PALmem 2wk post Rx
|
4.14 units on a scale
Standard Error 0.857
|
3.75 units on a scale
Standard Error 1.06
|
|
Cognitive Measures Incluing ADAScog, Selected CANTABS Tests (Paired Associate Learning (PAL)and PAL )
PALmem 4wk post RX
|
5.50 units on a scale
Standard Error 1.477
|
4.75 units on a scale
Standard Error 0.881
|
|
Cognitive Measures Incluing ADAScog, Selected CANTABS Tests (Paired Associate Learning (PAL)and PAL )
PAL (tot trial adj) baseline
|
33.87 units on a scale
Standard Error 3.02
|
33.87 units on a scale
Standard Error 3.02
|
|
Cognitive Measures Incluing ADAScog, Selected CANTABS Tests (Paired Associate Learning (PAL)and PAL )
PAL (tot trial adj) 2wk post Rx
|
28.48 units on a scale
Standard Error 6.16
|
33.62 units on a scale
Standard Error 4.26
|
|
Cognitive Measures Incluing ADAScog, Selected CANTABS Tests (Paired Associate Learning (PAL)and PAL )
PAL(tot trial adj) 4wk post RX
|
24.45 units on a scale
Standard Error 5.36
|
30.62 units on a scale
Standard Error 3.02
|
PRIMARY outcome
Timeframe: Baseline and final visit (14 wks)Scores from each of the cognitive assessments: mean ADAScog: a decrease in total score units = improvement, min=0 max= mean PAL (memory): an increase in score = improvement, mean PAL (total trial adj): a decrease in score = improvement,
Outcome measures
| Measure |
G-CSF
n=8 Participants
All participants received G-CSF either in the first or second phase of the crossover
|
Placebo
All participants received placebo either in the first or second phase of crossover
|
|---|---|---|
|
Cognitive Measures Incluing ADAScog, Selected CANTABS Tests (Paired Associate Learning (PAL)and PAL )
PAL (tot trials adj) 14wk post RX
|
30. units on a scale
Standard Error 3.65
|
—
|
|
Cognitive Measures Incluing ADAScog, Selected CANTABS Tests (Paired Associate Learning (PAL)and PAL )
ADAScog Baseline
|
24 units on a scale
Standard Error 2.86
|
—
|
|
Cognitive Measures Incluing ADAScog, Selected CANTABS Tests (Paired Associate Learning (PAL)and PAL )
ADAScog 14wks post Rx
|
20.37 units on a scale
Standard Error 2.25
|
—
|
|
Cognitive Measures Incluing ADAScog, Selected CANTABS Tests (Paired Associate Learning (PAL)and PAL )
PALmem baseline
|
2.85 units on a scale
Standard Error 0.67
|
—
|
|
Cognitive Measures Incluing ADAScog, Selected CANTABS Tests (Paired Associate Learning (PAL)and PAL )
PALmem 14wk post RX
|
5.17 units on a scale
Standard Error 1.41
|
—
|
|
Cognitive Measures Incluing ADAScog, Selected CANTABS Tests (Paired Associate Learning (PAL)and PAL )
PAL (tot trials adj) baseline
|
33.88 units on a scale
Standard Error 3.003
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
G-CSF
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=8 participants at risk
subjects who received placebo in either phase of the study
|
G-CSF
n=8 participants at risk
participants who received GCSF injecitons during first or second phase
|
|---|---|---|
|
Nervous system disorders
headache
|
12.5%
1/8 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
generalized aches
|
25.0%
2/8 • Number of events 2
|
62.5%
5/8 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
back pain
|
50.0%
4/8 • Number of events 4
|
37.5%
3/8 • Number of events 3
|
|
Nervous system disorders
nausea
|
12.5%
1/8 • Number of events 1
|
12.5%
1/8 • Number of events 1
|
|
Nervous system disorders
visual hallucinations
|
12.5%
1/8 • Number of events 1
|
0.00%
0/8
|
Additional Information
Professor Juan Sanchez-Ramos
University of South Florida
Phone: 813-974-5841
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place