Trial Outcomes & Findings for A PET Study of the Effects of p38 MAP Kinase Inhibitor, VX-745, on Amyloid Plaque Load in Alzheimer's Disease (AD) (NCT NCT02423122)
NCT ID: NCT02423122
Last Updated: 2019-06-14
Results Overview
Percent change in global cortical amyloid specific PET signal (BPND)
COMPLETED
PHASE2
16 participants
Baseline compared to following 12 weeks' dosing with VX-745
2019-06-14
Participant Flow
Participant milestones
| Measure |
Neflamapimod (VX-745) Dose 1
Active Group 1: VX-745 40 mg twice daily
VX-745: Orally-Active Selective P45 MAP Kinase inhibitor
|
Neflamapimod (VX-745) Dose 2
Active Group 2: VX-745 125 mg twice daily
VX-745: Orally-Active Selective P45 MAP Kinase inhibitor
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
7
|
|
Overall Study
COMPLETED
|
9
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A PET Study of the Effects of p38 MAP Kinase Inhibitor, VX-745, on Amyloid Plaque Load in Alzheimer's Disease (AD)
Baseline characteristics by cohort
| Measure |
Neflamapimod (VX-745) Dose 1
n=9 Participants
Active Group 1: VX-745 40 mg twice daily
VX-745: Orally-Active Selective P45 MAP Kinase inhibitor
|
Neflamapimod (VX-745) Dose 2
n=7 Participants
Active Group 2: VX-745 125 mg twice daily
VX-745: Orally-Active Selective P45 MAP Kinase inhibitor
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
n=5 Participants
|
65 years
n=7 Participants
|
66.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
9 participants
n=5 Participants
|
7 participants
n=7 Participants
|
16 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline compared to following 12 weeks' dosing with VX-745Population: All patients with baseline and Day 84 11C-PiB scan. One patient in 40 mg dose group could not cooperate for Day 84 PET scan due to having developed MRI-induced panic attack.
Percent change in global cortical amyloid specific PET signal (BPND)
Outcome measures
| Measure |
Neflamapimod (VX-745) Dose 1
n=8 Participants
Active Group 1: VX-745 40 mg twice daily
VX-745: Orally-Active Selective P45 MAP Kinase inhibitor
|
Neflamapimod (VX-745) Dose 2
n=7 Participants
Active Group 2: VX-745 125 mg twice daily
VX-745: Orally-Active Selective P45 MAP Kinase inhibitor
|
|---|---|---|
|
Percent Change From Baseline in Amyloid Plaque Burden by 11C-PiB PET
|
-4.57 percentage change from baseline
Interval -11.65 to 4.83
|
4.57 percentage change from baseline
Interval 0.56 to 12.25
|
PRIMARY outcome
Timeframe: Day 84Population: All patients with baseline and Day 84 11C-PiB scan. One patient in 40 mg dose group could not cooperate for Day 84 PET scan due to having developed MRI-induced panic attack.
Number of patients meeting protocol pre-specified definition of response: \> 7% reduction in global cortical BPND
Outcome measures
| Measure |
Neflamapimod (VX-745) Dose 1
n=8 Participants
Active Group 1: VX-745 40 mg twice daily
VX-745: Orally-Active Selective P45 MAP Kinase inhibitor
|
Neflamapimod (VX-745) Dose 2
n=7 Participants
Active Group 2: VX-745 125 mg twice daily
VX-745: Orally-Active Selective P45 MAP Kinase inhibitor
|
|---|---|---|
|
Number of 11C-PiB Responders
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 84Population: All patients with baseline and day 84 WMS testing data. One subject in 40 mg dose group did not complete the Day 84 WMS assessment after having developed MRI-induced panic attack.
WMS immediate-recall composite score consisted of the sum of the scores on Logical Memory I, Verbal Paired Associates I, and Visual Reproduction I. The composite score ranges from 0 to 136; with higher score indicating better performance.
Outcome measures
| Measure |
Neflamapimod (VX-745) Dose 1
n=8 Participants
Active Group 1: VX-745 40 mg twice daily
VX-745: Orally-Active Selective P45 MAP Kinase inhibitor
|
Neflamapimod (VX-745) Dose 2
n=7 Participants
Active Group 2: VX-745 125 mg twice daily
VX-745: Orally-Active Selective P45 MAP Kinase inhibitor
|
|---|---|---|
|
Wechsler Memory Scale (WMS) Immediate Recall Composite
|
7.0 units on a scale
Standard Deviation 11.0
|
13.4 units on a scale
Standard Deviation 12.2
|
SECONDARY outcome
Timeframe: Change from baseline to Day 84Population: All patients with baseline and day 84 WMS testing data. One subject in 40 mg dose group did not complete the Day 84 WMS assessment after having developed MRI-induced panic attack.
WMS delayed-recall composite score at each testing sessions consisted of the sum of the scores on Logical Memory II, Verbal Paired Associates II, and Visual Reproduction II. The composite score ranges from 0 to 136; with higher scores indicating better performance.
Outcome measures
| Measure |
Neflamapimod (VX-745) Dose 1
n=8 Participants
Active Group 1: VX-745 40 mg twice daily
VX-745: Orally-Active Selective P45 MAP Kinase inhibitor
|
Neflamapimod (VX-745) Dose 2
n=7 Participants
Active Group 2: VX-745 125 mg twice daily
VX-745: Orally-Active Selective P45 MAP Kinase inhibitor
|
|---|---|---|
|
Wechsler Memory Scale (WMS) Delayed Recall Composite
|
7.5 units on a scale
Standard Deviation 7.0
|
10.4 units on a scale
Standard Deviation 11.9
|
Adverse Events
40 mg Dose Group
125 mg Dose Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
40 mg Dose Group
n=9 participants at risk
|
125 mg Dose Group
n=7 participants at risk
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
3/9 • Number of events 3
|
0.00%
0/7
|
|
Nervous system disorders
Somnolence
|
11.1%
1/9 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
11.1%
1/9 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
|
General disorders
Influenza like illness
|
11.1%
1/9 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60