Trial Outcomes & Findings for Safety and Efficacy Study of Ladostigil in Mild to Moderate Probable Alzheimer's Disease (NCT NCT01354691)
NCT ID: NCT01354691
Last Updated: 2020-07-30
Results Overview
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) is a brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia, The ADAS-Cog consist of 11 questions: Word Recall Task Naming Objects and Fingers Following Commands Constructional Praxis Ideational Praxis Orientation Word Recognition Task Remembering Test Directions Spoken Language Comprehension Word-Finding Difficulty Item scores are summed. Low total scores indicate better cognitive performance. Minimum score 0 is best and maximum is 70 - worst. For the purposes of analyses the change from baseline is computed to each administration of the test.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
200 participants
Primary outcome timeframe
26 weeks
Results posted on
2020-07-30
Participant Flow
Participant milestones
| Measure |
Ladostigil Hemitartrate
Ladostigil capsules 80 mg
ladostigil hemitartrate: Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths. Oral, solid dosage.
|
Placebo
Placebo capsules
ladostigil hemitartrate: Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths. Oral, solid dosage.
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
99
|
|
Overall Study
ITT
|
99
|
96
|
|
Overall Study
PP
|
79
|
75
|
|
Overall Study
COMPLETED
|
80
|
77
|
|
Overall Study
NOT COMPLETED
|
21
|
22
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study of Ladostigil in Mild to Moderate Probable Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Ladostigil Hemitartrate
n=101 Participants
Ladostigil capsules 80 mg
ladostigil hemitartrate: Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths. Oral, solid dosage.
|
Placebo
n=99 Participants
Placebo capsules
ladostigil hemitartrate: Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths. Oral, solid dosage.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=113 Participants
|
15 Participants
n=163 Participants
|
30 Participants
n=160 Participants
|
|
Age, Categorical
>=65 years
|
86 Participants
n=113 Participants
|
84 Participants
n=163 Participants
|
170 Participants
n=160 Participants
|
|
Age, Continuous
|
74.25 years
STANDARD_DEVIATION 6.73 • n=113 Participants
|
74.28 years
STANDARD_DEVIATION 6.92 • n=163 Participants
|
74.26 years
STANDARD_DEVIATION 6.8 • n=160 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=113 Participants
|
60 Participants
n=163 Participants
|
116 Participants
n=160 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=113 Participants
|
39 Participants
n=163 Participants
|
84 Participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White or Caucasian
|
101 Participants
n=113 Participants
|
99 Participants
n=163 Participants
|
200 Participants
n=160 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other
|
0 Participants
n=113 Participants
|
0 Participants
n=163 Participants
|
0 Participants
n=160 Participants
|
|
Region of Enrollment
Austria
|
28 participants
n=113 Participants
|
27 participants
n=163 Participants
|
55 participants
n=160 Participants
|
|
Region of Enrollment
Serbia
|
4 participants
n=113 Participants
|
2 participants
n=163 Participants
|
6 participants
n=160 Participants
|
|
Region of Enrollment
Germany
|
9 participants
n=113 Participants
|
8 participants
n=163 Participants
|
17 participants
n=160 Participants
|
|
Region of Enrollment
Croatia
|
44 participants
n=113 Participants
|
45 participants
n=163 Participants
|
89 participants
n=160 Participants
|
|
Region of Enrollment
Spain
|
16 participants
n=113 Participants
|
17 participants
n=163 Participants
|
33 participants
n=160 Participants
|
PRIMARY outcome
Timeframe: 26 weeksAlzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) is a brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia, The ADAS-Cog consist of 11 questions: Word Recall Task Naming Objects and Fingers Following Commands Constructional Praxis Ideational Praxis Orientation Word Recognition Task Remembering Test Directions Spoken Language Comprehension Word-Finding Difficulty Item scores are summed. Low total scores indicate better cognitive performance. Minimum score 0 is best and maximum is 70 - worst. For the purposes of analyses the change from baseline is computed to each administration of the test.
Outcome measures
| Measure |
Ladostigil Hemitartrate
n=99 Participants
Ladostigil capsules 80 mg
ladostigil hemitartrate: Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths. Oral, solid dosage.
|
Placebo
n=96 Participants
Placebo capsules
ladostigil hemitartrate: Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths. Oral, solid dosage.
|
|---|---|---|
|
ADAS-Cog: Alzheimer's Disease Assessment Scale-Cognitive Subscale
|
-.27 score on scale - baseline to endpoint
Standard Deviation 5.41
|
0.19 score on scale - baseline to endpoint
Standard Deviation 5.15
|
SECONDARY outcome
Timeframe: 52 weeksThe Neuropsychiatric Inventory (NPI) was developed to assess psychopathology in dementia patients. It evaluates 12 neuropsychiatric disturbances common in dementia: delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor behavior, night-time behavior disturbances, and appetite and eating abnormalities. The severity and frequency of each neuropsychiatric symptom are rated on the basis of scripted questions administered to the patient's caregiver. Higher the score the more disturbed, lower score is thus better. Minimum score is 0 and maximum is 80.
Outcome measures
| Measure |
Ladostigil Hemitartrate
n=99 Participants
Ladostigil capsules 80 mg
ladostigil hemitartrate: Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths. Oral, solid dosage.
|
Placebo
n=96 Participants
Placebo capsules
ladostigil hemitartrate: Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths. Oral, solid dosage.
|
|---|---|---|
|
Neuropsychiatric Inventory (NPI)
|
2.51 score on scale - baseline to endpoint
Standard Deviation 11.27
|
0.66 score on scale - baseline to endpoint
Standard Deviation 7.90
|
SECONDARY outcome
Timeframe: 52 weeksThe Cornell Scale for Depression in Dementia (CSDD) was developed specifically to assess signs and symptoms of major depression in dementia on the basis of a semi-structured interview of a qualified informant. The CSDD evaluates a broad spectrum of depressive signs and synptoms and includes items from other depression scales. Information is obtained from interview of the caregiver as well as from direct observation and interview of the patient CSDD is a 19 item scale assessing depressive status. Higher score more depression. The scale ranges from 0-no depression to 38 maximum depression.
Outcome measures
| Measure |
Ladostigil Hemitartrate
n=93 Participants
Ladostigil capsules 80 mg
ladostigil hemitartrate: Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths. Oral, solid dosage.
|
Placebo
n=86 Participants
Placebo capsules
ladostigil hemitartrate: Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths. Oral, solid dosage.
|
|---|---|---|
|
Cornell Scale for Depression in Dementia (CSDD)
|
-0.08 score on scale - baseline to endpoint
Standard Deviation 2.81
|
-0.45 score on scale - baseline to endpoint
Standard Deviation 3.28
|
SECONDARY outcome
Timeframe: 52 weeksThe Activities of Daily Living ADCS-ADL is a caregiver-based ADL scale composed of 23 items developed for use in dementia clinical trials. It is designed to assess the patient's performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests as well as making judgments and decisions. For each ADL, the caregiver is asked whether the patient attempted the activity during the past four weeks. If the answer is positive, the caregiver is then asked to choose the single most accurate definition of the patient's level of performance. Assessment of functional activity status is a 23 item scale measuring impairment in functioning. The scale total score ranges from 0-profound impairment to 30 normal functioning (no impairments)
Outcome measures
| Measure |
Ladostigil Hemitartrate
n=99 Participants
Ladostigil capsules 80 mg
ladostigil hemitartrate: Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths. Oral, solid dosage.
|
Placebo
n=96 Participants
Placebo capsules
ladostigil hemitartrate: Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths. Oral, solid dosage.
|
|---|---|---|
|
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
|
-1.88 score on scale - baseline to endpoint
Standard Deviation 9.54
|
-1.57 score on scale - baseline to endpoint
Standard Deviation 7.72
|
SECONDARY outcome
Timeframe: 52 weeksThe MMSE is a frequently used screening instrument for AD drug studies. The instrument provides for evaluation of orientation, memory, attention, concentration, naming, repetition, comprehension, ability to create a sentence and to copy two intersecting polygons. This examination is frequently used by physicians in the original diagnosis of AD, and in its subsequent progression, because it can be easily performed in the routine care of patients. A lower score indicates more cognitive impairment. The highest (best) score is 30. The Mini-Mental State Examination, MMSE, is a 30-point questionnaire measures cognitive impairment to screen for dementia. Items are totaled. The scale ranges from 0-most impairment to 30 (normal) no impairment.
Outcome measures
| Measure |
Ladostigil Hemitartrate
n=99 Participants
Ladostigil capsules 80 mg
ladostigil hemitartrate: Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths. Oral, solid dosage.
|
Placebo
n=96 Participants
Placebo capsules
ladostigil hemitartrate: Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths. Oral, solid dosage.
|
|---|---|---|
|
Mini-Mental State Examination
|
0.80 change in score - baseline to endpoint
Standard Deviation 2.73
|
0.60 change in score - baseline to endpoint
Standard Deviation 2.59
|
Adverse Events
Ladostigil Hemitartrate
Serious events: 7 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 7 serious events
Other events: 2 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Ladostigil Hemitartrate
n=100 participants at risk
Ladostigil capsules 80 mg
ladostigil hemitartrate: Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths. Oral, solid dosage.
|
Placebo
n=98 participants at risk
Placebo capsules
ladostigil hemitartrate: Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths. Oral, solid dosage.
|
|---|---|---|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCT
|
1.0%
1/100 • Number of events 1 • 26 weeks
Enrolled patients Ladostigil 101(100.0%) Placebo 99(100.0%) ITT Population Ladostigil 99(98.02%) Placebo 96(96.97%) PP Population Ladostigil 79(78.22%) Placebo 75(75.76%) Safety Population Ladostigil 100(99.01%) Placebo 98(98.99%) one patient discontinued the study in each group before administration of drug that is why the Safety Population is: Ladostigil 100(99.01%) Placebo 98(98.99%)
|
0.00%
0/98 • 26 weeks
Enrolled patients Ladostigil 101(100.0%) Placebo 99(100.0%) ITT Population Ladostigil 99(98.02%) Placebo 96(96.97%) PP Population Ladostigil 79(78.22%) Placebo 75(75.76%) Safety Population Ladostigil 100(99.01%) Placebo 98(98.99%) one patient discontinued the study in each group before administration of drug that is why the Safety Population is: Ladostigil 100(99.01%) Placebo 98(98.99%)
|
|
Vascular disorders
Brain Stroke
|
1.0%
1/100 • Number of events 1 • 26 weeks
Enrolled patients Ladostigil 101(100.0%) Placebo 99(100.0%) ITT Population Ladostigil 99(98.02%) Placebo 96(96.97%) PP Population Ladostigil 79(78.22%) Placebo 75(75.76%) Safety Population Ladostigil 100(99.01%) Placebo 98(98.99%) one patient discontinued the study in each group before administration of drug that is why the Safety Population is: Ladostigil 100(99.01%) Placebo 98(98.99%)
|
0.00%
0/98 • 26 weeks
Enrolled patients Ladostigil 101(100.0%) Placebo 99(100.0%) ITT Population Ladostigil 99(98.02%) Placebo 96(96.97%) PP Population Ladostigil 79(78.22%) Placebo 75(75.76%) Safety Population Ladostigil 100(99.01%) Placebo 98(98.99%) one patient discontinued the study in each group before administration of drug that is why the Safety Population is: Ladostigil 100(99.01%) Placebo 98(98.99%)
|
|
Musculoskeletal and connective tissue disorders
Elbow Fracture
|
1.0%
1/100 • Number of events 1 • 26 weeks
Enrolled patients Ladostigil 101(100.0%) Placebo 99(100.0%) ITT Population Ladostigil 99(98.02%) Placebo 96(96.97%) PP Population Ladostigil 79(78.22%) Placebo 75(75.76%) Safety Population Ladostigil 100(99.01%) Placebo 98(98.99%) one patient discontinued the study in each group before administration of drug that is why the Safety Population is: Ladostigil 100(99.01%) Placebo 98(98.99%)
|
0.00%
0/98 • 26 weeks
Enrolled patients Ladostigil 101(100.0%) Placebo 99(100.0%) ITT Population Ladostigil 99(98.02%) Placebo 96(96.97%) PP Population Ladostigil 79(78.22%) Placebo 75(75.76%) Safety Population Ladostigil 100(99.01%) Placebo 98(98.99%) one patient discontinued the study in each group before administration of drug that is why the Safety Population is: Ladostigil 100(99.01%) Placebo 98(98.99%)
|
|
Musculoskeletal and connective tissue disorders
Femur fracture subtrochan
|
1.0%
1/100 • Number of events 1 • 26 weeks
Enrolled patients Ladostigil 101(100.0%) Placebo 99(100.0%) ITT Population Ladostigil 99(98.02%) Placebo 96(96.97%) PP Population Ladostigil 79(78.22%) Placebo 75(75.76%) Safety Population Ladostigil 100(99.01%) Placebo 98(98.99%) one patient discontinued the study in each group before administration of drug that is why the Safety Population is: Ladostigil 100(99.01%) Placebo 98(98.99%)
|
0.00%
0/98 • 26 weeks
Enrolled patients Ladostigil 101(100.0%) Placebo 99(100.0%) ITT Population Ladostigil 99(98.02%) Placebo 96(96.97%) PP Population Ladostigil 79(78.22%) Placebo 75(75.76%) Safety Population Ladostigil 100(99.01%) Placebo 98(98.99%) one patient discontinued the study in each group before administration of drug that is why the Safety Population is: Ladostigil 100(99.01%) Placebo 98(98.99%)
|
|
Respiratory, thoracic and mediastinal disorders
Sick Sinus Syndrome
|
1.0%
1/100 • Number of events 1 • 26 weeks
Enrolled patients Ladostigil 101(100.0%) Placebo 99(100.0%) ITT Population Ladostigil 99(98.02%) Placebo 96(96.97%) PP Population Ladostigil 79(78.22%) Placebo 75(75.76%) Safety Population Ladostigil 100(99.01%) Placebo 98(98.99%) one patient discontinued the study in each group before administration of drug that is why the Safety Population is: Ladostigil 100(99.01%) Placebo 98(98.99%)
|
0.00%
0/98 • 26 weeks
Enrolled patients Ladostigil 101(100.0%) Placebo 99(100.0%) ITT Population Ladostigil 99(98.02%) Placebo 96(96.97%) PP Population Ladostigil 79(78.22%) Placebo 75(75.76%) Safety Population Ladostigil 100(99.01%) Placebo 98(98.99%) one patient discontinued the study in each group before administration of drug that is why the Safety Population is: Ladostigil 100(99.01%) Placebo 98(98.99%)
|
|
Injury, poisoning and procedural complications
Sun Stroke
|
1.0%
1/100 • Number of events 1 • 26 weeks
Enrolled patients Ladostigil 101(100.0%) Placebo 99(100.0%) ITT Population Ladostigil 99(98.02%) Placebo 96(96.97%) PP Population Ladostigil 79(78.22%) Placebo 75(75.76%) Safety Population Ladostigil 100(99.01%) Placebo 98(98.99%) one patient discontinued the study in each group before administration of drug that is why the Safety Population is: Ladostigil 100(99.01%) Placebo 98(98.99%)
|
0.00%
0/98 • 26 weeks
Enrolled patients Ladostigil 101(100.0%) Placebo 99(100.0%) ITT Population Ladostigil 99(98.02%) Placebo 96(96.97%) PP Population Ladostigil 79(78.22%) Placebo 75(75.76%) Safety Population Ladostigil 100(99.01%) Placebo 98(98.99%) one patient discontinued the study in each group before administration of drug that is why the Safety Population is: Ladostigil 100(99.01%) Placebo 98(98.99%)
|
|
Respiratory, thoracic and mediastinal disorders
Thoracic Pain
|
1.0%
1/100 • Number of events 1 • 26 weeks
Enrolled patients Ladostigil 101(100.0%) Placebo 99(100.0%) ITT Population Ladostigil 99(98.02%) Placebo 96(96.97%) PP Population Ladostigil 79(78.22%) Placebo 75(75.76%) Safety Population Ladostigil 100(99.01%) Placebo 98(98.99%) one patient discontinued the study in each group before administration of drug that is why the Safety Population is: Ladostigil 100(99.01%) Placebo 98(98.99%)
|
0.00%
0/98 • 26 weeks
Enrolled patients Ladostigil 101(100.0%) Placebo 99(100.0%) ITT Population Ladostigil 99(98.02%) Placebo 96(96.97%) PP Population Ladostigil 79(78.22%) Placebo 75(75.76%) Safety Population Ladostigil 100(99.01%) Placebo 98(98.99%) one patient discontinued the study in each group before administration of drug that is why the Safety Population is: Ladostigil 100(99.01%) Placebo 98(98.99%)
|
|
Gastrointestinal disorders
Acute Cholecystitis
|
0.00%
0/100 • 26 weeks
Enrolled patients Ladostigil 101(100.0%) Placebo 99(100.0%) ITT Population Ladostigil 99(98.02%) Placebo 96(96.97%) PP Population Ladostigil 79(78.22%) Placebo 75(75.76%) Safety Population Ladostigil 100(99.01%) Placebo 98(98.99%) one patient discontinued the study in each group before administration of drug that is why the Safety Population is: Ladostigil 100(99.01%) Placebo 98(98.99%)
|
1.0%
1/98 • Number of events 1 • 26 weeks
Enrolled patients Ladostigil 101(100.0%) Placebo 99(100.0%) ITT Population Ladostigil 99(98.02%) Placebo 96(96.97%) PP Population Ladostigil 79(78.22%) Placebo 75(75.76%) Safety Population Ladostigil 100(99.01%) Placebo 98(98.99%) one patient discontinued the study in each group before administration of drug that is why the Safety Population is: Ladostigil 100(99.01%) Placebo 98(98.99%)
|
|
Musculoskeletal and connective tissue disorders
Arthritis left ankle
|
0.00%
0/100 • 26 weeks
Enrolled patients Ladostigil 101(100.0%) Placebo 99(100.0%) ITT Population Ladostigil 99(98.02%) Placebo 96(96.97%) PP Population Ladostigil 79(78.22%) Placebo 75(75.76%) Safety Population Ladostigil 100(99.01%) Placebo 98(98.99%) one patient discontinued the study in each group before administration of drug that is why the Safety Population is: Ladostigil 100(99.01%) Placebo 98(98.99%)
|
1.0%
1/98 • Number of events 1 • 26 weeks
Enrolled patients Ladostigil 101(100.0%) Placebo 99(100.0%) ITT Population Ladostigil 99(98.02%) Placebo 96(96.97%) PP Population Ladostigil 79(78.22%) Placebo 75(75.76%) Safety Population Ladostigil 100(99.01%) Placebo 98(98.99%) one patient discontinued the study in each group before administration of drug that is why the Safety Population is: Ladostigil 100(99.01%) Placebo 98(98.99%)
|
|
Gastrointestinal disorders
Obstipation
|
0.00%
0/100 • 26 weeks
Enrolled patients Ladostigil 101(100.0%) Placebo 99(100.0%) ITT Population Ladostigil 99(98.02%) Placebo 96(96.97%) PP Population Ladostigil 79(78.22%) Placebo 75(75.76%) Safety Population Ladostigil 100(99.01%) Placebo 98(98.99%) one patient discontinued the study in each group before administration of drug that is why the Safety Population is: Ladostigil 100(99.01%) Placebo 98(98.99%)
|
1.0%
1/98 • Number of events 1 • 26 weeks
Enrolled patients Ladostigil 101(100.0%) Placebo 99(100.0%) ITT Population Ladostigil 99(98.02%) Placebo 96(96.97%) PP Population Ladostigil 79(78.22%) Placebo 75(75.76%) Safety Population Ladostigil 100(99.01%) Placebo 98(98.99%) one patient discontinued the study in each group before administration of drug that is why the Safety Population is: Ladostigil 100(99.01%) Placebo 98(98.99%)
|
|
Respiratory, thoracic and mediastinal disorders
Pneunomia
|
0.00%
0/100 • 26 weeks
Enrolled patients Ladostigil 101(100.0%) Placebo 99(100.0%) ITT Population Ladostigil 99(98.02%) Placebo 96(96.97%) PP Population Ladostigil 79(78.22%) Placebo 75(75.76%) Safety Population Ladostigil 100(99.01%) Placebo 98(98.99%) one patient discontinued the study in each group before administration of drug that is why the Safety Population is: Ladostigil 100(99.01%) Placebo 98(98.99%)
|
1.0%
1/98 • Number of events 1 • 26 weeks
Enrolled patients Ladostigil 101(100.0%) Placebo 99(100.0%) ITT Population Ladostigil 99(98.02%) Placebo 96(96.97%) PP Population Ladostigil 79(78.22%) Placebo 75(75.76%) Safety Population Ladostigil 100(99.01%) Placebo 98(98.99%) one patient discontinued the study in each group before administration of drug that is why the Safety Population is: Ladostigil 100(99.01%) Placebo 98(98.99%)
|
|
Injury, poisoning and procedural complications
POLYTRAUMATISM
|
0.00%
0/100 • 26 weeks
Enrolled patients Ladostigil 101(100.0%) Placebo 99(100.0%) ITT Population Ladostigil 99(98.02%) Placebo 96(96.97%) PP Population Ladostigil 79(78.22%) Placebo 75(75.76%) Safety Population Ladostigil 100(99.01%) Placebo 98(98.99%) one patient discontinued the study in each group before administration of drug that is why the Safety Population is: Ladostigil 100(99.01%) Placebo 98(98.99%)
|
1.0%
1/98 • Number of events 1 • 26 weeks
Enrolled patients Ladostigil 101(100.0%) Placebo 99(100.0%) ITT Population Ladostigil 99(98.02%) Placebo 96(96.97%) PP Population Ladostigil 79(78.22%) Placebo 75(75.76%) Safety Population Ladostigil 100(99.01%) Placebo 98(98.99%) one patient discontinued the study in each group before administration of drug that is why the Safety Population is: Ladostigil 100(99.01%) Placebo 98(98.99%)
|
|
Infections and infestations
Urinary Infection
|
0.00%
0/100 • 26 weeks
Enrolled patients Ladostigil 101(100.0%) Placebo 99(100.0%) ITT Population Ladostigil 99(98.02%) Placebo 96(96.97%) PP Population Ladostigil 79(78.22%) Placebo 75(75.76%) Safety Population Ladostigil 100(99.01%) Placebo 98(98.99%) one patient discontinued the study in each group before administration of drug that is why the Safety Population is: Ladostigil 100(99.01%) Placebo 98(98.99%)
|
2.0%
2/98 • Number of events 2 • 26 weeks
Enrolled patients Ladostigil 101(100.0%) Placebo 99(100.0%) ITT Population Ladostigil 99(98.02%) Placebo 96(96.97%) PP Population Ladostigil 79(78.22%) Placebo 75(75.76%) Safety Population Ladostigil 100(99.01%) Placebo 98(98.99%) one patient discontinued the study in each group before administration of drug that is why the Safety Population is: Ladostigil 100(99.01%) Placebo 98(98.99%)
|
Other adverse events
| Measure |
Ladostigil Hemitartrate
n=100 participants at risk
Ladostigil capsules 80 mg
ladostigil hemitartrate: Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths. Oral, solid dosage.
|
Placebo
n=98 participants at risk
Placebo capsules
ladostigil hemitartrate: Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths. Oral, solid dosage.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.0%
6/100 • Number of events 6 • 26 weeks
Enrolled patients Ladostigil 101(100.0%) Placebo 99(100.0%) ITT Population Ladostigil 99(98.02%) Placebo 96(96.97%) PP Population Ladostigil 79(78.22%) Placebo 75(75.76%) Safety Population Ladostigil 100(99.01%) Placebo 98(98.99%) one patient discontinued the study in each group before administration of drug that is why the Safety Population is: Ladostigil 100(99.01%) Placebo 98(98.99%)
|
2.0%
2/98 • Number of events 3 • 26 weeks
Enrolled patients Ladostigil 101(100.0%) Placebo 99(100.0%) ITT Population Ladostigil 99(98.02%) Placebo 96(96.97%) PP Population Ladostigil 79(78.22%) Placebo 75(75.76%) Safety Population Ladostigil 100(99.01%) Placebo 98(98.99%) one patient discontinued the study in each group before administration of drug that is why the Safety Population is: Ladostigil 100(99.01%) Placebo 98(98.99%)
|
|
Cardiac disorders
Essential hypertension
|
6.0%
6/100 • Number of events 6 • 26 weeks
Enrolled patients Ladostigil 101(100.0%) Placebo 99(100.0%) ITT Population Ladostigil 99(98.02%) Placebo 96(96.97%) PP Population Ladostigil 79(78.22%) Placebo 75(75.76%) Safety Population Ladostigil 100(99.01%) Placebo 98(98.99%) one patient discontinued the study in each group before administration of drug that is why the Safety Population is: Ladostigil 100(99.01%) Placebo 98(98.99%)
|
0.00%
0/98 • 26 weeks
Enrolled patients Ladostigil 101(100.0%) Placebo 99(100.0%) ITT Population Ladostigil 99(98.02%) Placebo 96(96.97%) PP Population Ladostigil 79(78.22%) Placebo 75(75.76%) Safety Population Ladostigil 100(99.01%) Placebo 98(98.99%) one patient discontinued the study in each group before administration of drug that is why the Safety Population is: Ladostigil 100(99.01%) Placebo 98(98.99%)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place