Trial Outcomes & Findings for A 3 Year Study to Evaluate the Safety and Efficacy of Low Dose Ladostigil in Patients With Mild Cognitive Impairment (NCT NCT01429623)
NCT ID: NCT01429623
Last Updated: 2017-06-15
Results Overview
Total number of conversions from Mild Cognitive Impairment to Alzheimer's disease across entire 3 year study period. Conversion is determined, or defined, by a Clinical Dementia Rating (CDR) score of greater than or equal to one. Composite rating ranges from 0 no symptoms of dementia to 3 Severe symptoms of dementia.
COMPLETED
PHASE2
210 participants
3,6,12,18,24,30 and 36 months
2017-06-15
Participant Flow
Recruitment between Feb. 17, 2012 and August 1, 2013.
Participant milestones
| Measure |
Ladostigil Hemitartrate
10mg ladostigil base
ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule
|
Placebo Control
drug product excipients
Placebo: Placebo comparator
|
|---|---|---|
|
Overall Study
STARTED
|
102
|
107
|
|
Overall Study
Converted to Alzheimer's
|
14
|
21
|
|
Overall Study
COMPLETED
|
51
|
48
|
|
Overall Study
NOT COMPLETED
|
51
|
59
|
Reasons for withdrawal
| Measure |
Ladostigil Hemitartrate
10mg ladostigil base
ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule
|
Placebo Control
drug product excipients
Placebo: Placebo comparator
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Adverse Event
|
7
|
14
|
|
Overall Study
Withdrawal by Subject
|
19
|
13
|
|
Overall Study
Physician Decision
|
2
|
3
|
|
Overall Study
Protocol Violation
|
3
|
2
|
|
Overall Study
Assorted
|
1
|
2
|
|
Overall Study
Conversion to Alzheimer's disease
|
14
|
21
|
|
Overall Study
No post baseline data
|
4
|
4
|
Baseline Characteristics
A 3 Year Study to Evaluate the Safety and Efficacy of Low Dose Ladostigil in Patients With Mild Cognitive Impairment
Baseline characteristics by cohort
| Measure |
Ladostigil Hemitartrate
n=103 Participants
10mg ladostigil base
ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule
|
Placebo Control
n=107 Participants
drug product excipients
Placebo: Placebo comparator
|
Total
n=210 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
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
88 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
|
Age, Continuous
|
71.3 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
71.4 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
71.35 years
STANDARD_DEVIATION 6.54 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
23 participants
n=5 Participants
|
24 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
47 participants
n=5 Participants
|
50 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
33 participants
n=5 Participants
|
33 participants
n=7 Participants
|
66 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3,6,12,18,24,30 and 36 monthsPopulation: All randomized subjects with at least one post-baseline visit.
Total number of conversions from Mild Cognitive Impairment to Alzheimer's disease across entire 3 year study period. Conversion is determined, or defined, by a Clinical Dementia Rating (CDR) score of greater than or equal to one. Composite rating ranges from 0 no symptoms of dementia to 3 Severe symptoms of dementia.
Outcome measures
| Measure |
Ladostigil Hemitartrate
n=99 Participants
10mg ladostigil base
ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule
|
Placebo Control
n=103 Participants
drug product excipients
Placebo: Placebo comparator
|
|---|---|---|
|
Conversion From Mild Cognitive Impairment to Alzheimer's Disease Compared to Placebo
|
14 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: 3,6,12,18,24,30 and 36 monthsPopulation: Modified Intent to Treat
Mean value change (from baseline) in Geriatric Depression Scale (GDS) across entire study period. The GDS ranges from 0 to 30. Scores of 0-9 are considered "normal", 10-19 "mildly depressed", and 20-30 "severely depressed".
Outcome measures
| Measure |
Ladostigil Hemitartrate
n=99 Participants
10mg ladostigil base
ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule
|
Placebo Control
n=103 Participants
drug product excipients
Placebo: Placebo comparator
|
|---|---|---|
|
Change in Geriatric Depression Scale for Ladostigil Versus Placebo Population
|
.084 Change from basline on units on a scale
Standard Deviation 1.70
|
.242 Change from basline on units on a scale
Standard Deviation 1.87
|
SECONDARY outcome
Timeframe: 3,6,12,18,24,30 and 36 monthsPopulation: Modified Intent to treat (all randomized subject with at least one post baseline assessment)
Mean value change (from baseline) in Neuropsychiatric Test Battery (NTB) across entire study period. The NTB included the following well known cognitive tests: Rey Auditory Verbal Learning Test (RAVLT), Controlled Word Association Test (COWAT), Category Fluency Test (CFT), WMS-R Digit Span, and Trail Making Part A and B. The mean value was comprised of the z score of each of these tests with all z scores in the direction of higher scores better functioning. Range -3 to +3.
Outcome measures
| Measure |
Ladostigil Hemitartrate
n=99 Participants
10mg ladostigil base
ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule
|
Placebo Control
n=103 Participants
drug product excipients
Placebo: Placebo comparator
|
|---|---|---|
|
Change in Neuropsychiatric Test Battery for Ladostigil Versus Placebo Population
|
.21 Change from basline on units on a scale
Standard Deviation .55
|
.17 Change from basline on units on a scale
Standard Deviation .43
|
SECONDARY outcome
Timeframe: 3,6,12,18,24,30 and 36 monthsMean value change (from baseline) in Disability Assessment in Dementia (DAD) across entire study period. DAD evaluates the basic and instrumental activities in daily activities of elderly people with dementia. Higher scores reflect better functioning. DAD ranges from 0 to 100.
Outcome measures
| Measure |
Ladostigil Hemitartrate
n=99 Participants
10mg ladostigil base
ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule
|
Placebo Control
n=103 Participants
drug product excipients
Placebo: Placebo comparator
|
|---|---|---|
|
Change in Disability Assessment in Dementia for Ladostigil Versus Placebo Population
|
-0.77 Change from basline on units on a scale
Standard Deviation 8.43
|
-0.40 Change from basline on units on a scale
Standard Deviation 5.11
|
Adverse Events
Ladostigil Hemitartrate
Placebo Control
Serious adverse events
| Measure |
Ladostigil Hemitartrate
n=103 participants at risk
10mg ladostigil base
ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule
|
Placebo Control
n=107 participants at risk
drug product excipients
Placebo: Placebo comparator
|
|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
2/103 • Number of events 2 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
General disorders
Chest pain
|
0.00%
0/103 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.93%
1/107 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/103 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
3.7%
4/107 • Number of events 5 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Blood and lymphatic system disorders
Chronic lymphocytic leukaemia
|
0.00%
0/103 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.93%
1/107 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Cardiac disorders
Angina unstable
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/103 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.93%
1/107 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Cardiac disorders
Cardiac arrest
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Cardiac disorders
Cardiac failure congestive
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Cardiac disorders
Coronary artery disease
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Cardiac disorders
Dyspnoea exertional
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Cardiac disorders
Extrasystoles
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/103 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.93%
1/107 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Cardiac disorders
Tachyarrhythmia
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Cardiac disorders
Ventricular tachycardia
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Eye disorders
Cataract
|
0.00%
0/103 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.93%
1/107 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Gastrointestinal disorders
Diverticulitis
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Gastrointestinal disorders
Gastric cancer
|
0.00%
0/103 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.93%
1/107 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/103 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.93%
1/107 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Gastrointestinal disorders
Metastases to peritoneum
|
0.00%
0/103 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.93%
1/107 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Gastrointestinal disorders
Oesophagitis
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Gastrointestinal disorders
Peritonitis
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Infections and infestations
Appendicitis
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.93%
1/107 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/103 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.93%
1/107 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Infections and infestations
Extradural abscess
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Infections and infestations
Pneumonia
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.93%
1/107 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Infections and infestations
Sepsis
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Infections and infestations
Viral infection
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Infections and infestations
Wound infection
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/103 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.93%
1/107 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Eye disorders
Intraocular pressure increased
|
0.00%
0/103 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.93%
1/107 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Musculoskeletal and connective tissue disorders
Fractured coccyx
|
0.00%
0/103 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.93%
1/107 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Musculoskeletal and connective tissue disorders
Humerus fracture
|
0.00%
0/103 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.93%
1/107 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Musculoskeletal and connective tissue disorders
Lower limb fracture
|
0.00%
0/103 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.93%
1/107 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/103 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.93%
1/107 • Number of events 2 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Musculoskeletal and connective tissue disorders
Pelvic floor muscle weakness
|
0.00%
0/103 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.93%
1/107 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Musculoskeletal and connective tissue disorders
Post polio syndrome
|
0.00%
0/103 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.93%
1/107 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Musculoskeletal and connective tissue disorders
Rib fracture
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/103 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.93%
1/107 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/103 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
2.8%
3/107 • Number of events 3 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/103 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.93%
1/107 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Nervous system disorders
Cervical spinal stenosis
|
0.00%
0/103 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.93%
1/107 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Nervous system disorders
Dizziness
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/103 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.93%
1/107 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Nervous system disorders
Headache
|
0.00%
0/103 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.93%
1/107 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Nervous system disorders
Loss of consciousness
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Nervous system disorders
Syncope
|
1.9%
2/103 • Number of events 2 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.00%
0/103 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.93%
1/107 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/103 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
1.9%
2/107 • Number of events 2 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Renal and urinary disorders
Haematuria
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.93%
1/107 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/103 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.93%
1/107 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Respiratory, thoracic and mediastinal disorders
Lung cancer metastatic
|
0.00%
0/103 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.93%
1/107 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia bacterial
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Skin and subcutaneous tissue disorders
Gangrene
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Skin and subcutaneous tissue disorders
Tinea pedis
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Surgical and medical procedures
Cataract operation
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Surgical and medical procedures
Glaucoma surgery
|
1.9%
2/103 • Number of events 5 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Surgical and medical procedures
Intraocular lens implant
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.00%
0/103 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.93%
1/107 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Surgical and medical procedures
Spinal laminectomy
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Surgical and medical procedures
Transurethral prostatectomy
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Vascular disorders
Accelerated hypertension
|
0.00%
0/103 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.93%
1/107 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Vascular disorders
Hypertension
|
0.00%
0/103 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.93%
1/107 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Vascular disorders
Ischaemic stroke
|
0.97%
1/103 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Vascular disorders
Peripheral vascular disorder
|
0.97%
1/103 • Number of events 2 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.00%
0/107 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Vascular disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/103 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
0.93%
1/107 • Number of events 1 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
Other adverse events
| Measure |
Ladostigil Hemitartrate
n=103 participants at risk
10mg ladostigil base
ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule
|
Placebo Control
n=107 participants at risk
drug product excipients
Placebo: Placebo comparator
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.8%
7/103 • Number of events 10 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
3.7%
4/107 • Number of events 4 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Cardiac disorders
Atrial fibrillation
|
5.8%
6/103 • Number of events 6 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
2.8%
3/107 • Number of events 3 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.9%
5/103 • Number of events 5 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
9.3%
10/107 • Number of events 10 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
General disorders
Fatigue
|
3.9%
4/103 • Number of events 4 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
6.5%
7/107 • Number of events 8 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Infections and infestations
Nasopharyngitis
|
10.7%
11/103 • Number of events 14 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
12.1%
13/107 • Number of events 15 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Nervous system disorders
Headache
|
6.8%
7/103 • Number of events 8 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
4.7%
5/107 • Number of events 5 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Psychiatric disorders
Depression
|
5.8%
6/103 • Number of events 6 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
2.8%
3/107 • Number of events 3 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.8%
7/103 • Number of events 8 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
6.5%
7/107 • Number of events 7 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
|
Surgical and medical procedures
Catarct operation
|
2.9%
3/103 • Number of events 4 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
6.5%
7/107 • Number of events 11 • 36 months
Treatment emergent adverse events (i.e., occurring after first drug administration)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place