Trial Outcomes & Findings for Efficacy and Safety of Lornoxicam in Patients With Mild to Moderate Probable Alzheimer´s Disease. (NCT NCT01117948)
NCT ID: NCT01117948
Last Updated: 2013-02-06
Results Overview
Alzheimer's disease Assessment Scale, Cognitive Subscale (15 item) Higher scores indicate cognitive impairment. All items are assessed by independent rater (psychologists). The score goes from 0 points (no cognitive impairment) to 95 points (maximum impairment in all 15 items). Primary Outcome Measure is the change from baseline ADAS-cog+ score to the score after 26 weeks (end of double blind).
TERMINATED
PHASE2
219 participants
6 months double blind, 6 months open-label (optional)
2013-02-06
Participant Flow
First patient in: 09 Nov 2009 Last patient out: 30 Apr 2011 Patients were recruited in Clinics and Outpatient Clinics
Patients were excluded if they did not meet all inclusion/exclusion criteria or if the caregiver was not giving consent to participation in the trial
Participant milestones
| Measure |
Lornoxicam
Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
|
Placebo
Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
|
|---|---|---|
|
Double Blind
STARTED
|
111
|
108
|
|
Double Blind
COMPLETED
|
93
|
98
|
|
Double Blind
NOT COMPLETED
|
18
|
10
|
|
Open Label
STARTED
|
93
|
98
|
|
Open Label
COMPLETED
|
41
|
51
|
|
Open Label
NOT COMPLETED
|
52
|
47
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety of Lornoxicam in Patients With Mild to Moderate Probable Alzheimer´s Disease.
Baseline characteristics by cohort
| Measure |
Lornoxicam
n=111 Participants
Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
|
Placebo
n=108 Participants
Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
|
Total
n=219 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
|
10 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
101 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
|
Age Continuous
|
74.5 years
STANDARD_DEVIATION 6.75 • n=5 Participants
|
73.6 years
STANDARD_DEVIATION 8.11 • n=7 Participants
|
74.1 years
STANDARD_DEVIATION 7.45 • n=5 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
35 participants
n=5 Participants
|
35 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
37 participants
n=5 Participants
|
41 participants
n=7 Participants
|
78 participants
n=5 Participants
|
|
Region of Enrollment
Slovakia
|
28 participants
n=5 Participants
|
21 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months double blind, 6 months open-label (optional)Alzheimer's disease Assessment Scale, Cognitive Subscale (15 item) Higher scores indicate cognitive impairment. All items are assessed by independent rater (psychologists). The score goes from 0 points (no cognitive impairment) to 95 points (maximum impairment in all 15 items). Primary Outcome Measure is the change from baseline ADAS-cog+ score to the score after 26 weeks (end of double blind).
Outcome measures
| Measure |
Lornoxicam
n=93 Participants
Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
|
Placebo
n=98 Participants
Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
|
|---|---|---|
|
Cognitive Performance - ADAS-cog+
|
-0.05 units on a scale
Standard Deviation 6.75
|
-0.89 units on a scale
Standard Deviation 7.84
|
SECONDARY outcome
Timeframe: 6 months double-blind, 6 months open label (optional)Outcome measures
Outcome data not reported
Adverse Events
Lornoxicam
Placebo
Serious adverse events
| Measure |
Lornoxicam
n=111 participants at risk
Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
|
Placebo
n=108 participants at risk
Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
|
|---|---|---|
|
Gastrointestinal disorders
Acute ulcus ventriculi
|
0.90%
1/111 • Number of events 1
|
0.00%
0/108
|
|
Gastrointestinal disorders
Duodenal Ulcer with Bulb Stenosis
|
0.90%
1/111 • Number of events 1
|
0.00%
0/108
|
|
Gastrointestinal disorders
Dyspepsia
|
0.90%
1/111 • Number of events 1
|
0.00%
0/108
|
|
Infections and infestations
External abscess on the neck
|
0.00%
0/111
|
0.93%
1/108 • Number of events 1
|
|
Gastrointestinal disorders
Gastric and duodenal ulcer
|
0.90%
1/111 • Number of events 1
|
0.00%
0/108
|
|
Gastrointestinal disorders
Intestinal bleeding
|
0.90%
1/111 • Number of events 1
|
0.00%
0/108
|
|
General disorders
Sudden death
|
0.90%
1/111 • Number of events 1
|
0.00%
0/108
|
|
Surgical and medical procedures
Surgery of lumbar spine
|
0.90%
1/111 • Number of events 1
|
0.00%
0/108
|
|
Gastrointestinal disorders
Ulcus duodeni perforation
|
0.90%
1/111 • Number of events 1
|
0.00%
0/108
|
|
Cardiac disorders
Syncope
|
0.00%
0/111
|
0.93%
1/108 • Number of events 1
|
|
Cardiac disorders
Myocard infarction
|
0.00%
0/111
|
0.93%
1/108 • Number of events 1
|
|
Psychiatric disorders
Organic disorder with delusions
|
0.90%
1/111 • Number of events 1
|
0.00%
0/108
|
|
Musculoskeletal and connective tissue disorders
Vertebral algic syndrom, Coxarthrosis - worsenig
|
0.90%
1/111 • Number of events 1
|
0.00%
0/108
|
|
Vascular disorders
Local ischemy in right cerebellum hemisphera
|
0.90%
1/111 • Number of events 1
|
0.00%
0/108
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60