Trial record 1 of 1 for:
NCT01429623
A 3 Year Study to Evaluate the Safety and Efficacy of Low Dose Ladostigil in Patients With Mild Cognitive Impairment
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| ClinicalTrials.gov Identifier: NCT01429623 |
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Recruitment Status :
Completed
First Posted : September 7, 2011
Results First Posted : June 15, 2017
Last Update Posted : June 15, 2017
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Sponsor:
Avraham Pharmaceuticals Ltd
Information provided by (Responsible Party):
Avraham Pharmaceuticals Ltd
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Conditions |
Mild Cognitive Impairment Dementia |
| Interventions |
Drug: ladostigil hemitartrate Drug: Placebo |
| Enrollment | 210 |
Participant Flow
| Recruitment Details | Recruitment between Feb. 17, 2012 and August 1, 2013. |
| Pre-assignment Details |
| Arm/Group Title | Ladostigil Hemitartrate | Placebo Control |
|---|---|---|
 Arm/Group Description |
10mg ladostigil base ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule |
drug product excipients Placebo: Placebo comparator |
| Period Title: Overall Study | ||
| Started | 102 [1] | 107 [2] |
| Converted to Alzheimer's [3] | 14 [4] | 21 [5] |
| Completed | 51 | 48 |
| Not Completed | 51 | 59 |
| Reason Not Completed | ||
| Death | 1 | 0 |
| Adverse Event | 7 | 14 |
| Withdrawal by Subject | 19 | 13 |
| Physician Decision | 2 | 3 |
| Protocol Violation | 3 | 2 |
| Assorted | 1 | 2 |
| Conversion to Alzheimer's disease | 14 | 21 |
| No post baseline data | 4 | 4 |
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[1]
103 allocated, 1 withdrew consent prior to first dose, 4 lacked post baseline data
[2]
107 allocated, 4 lacked post baseline data
[3]
Upon conversion to Alzheimer's disease, the primary endpoint, subjects removed from study
[4]
14 of 99
[5]
21 of 103
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Baseline Characteristics
| Arm/Group Title | Ladostigil Hemitartrate | Placebo Control | Total | |
|---|---|---|---|---|
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Arm/Group Description |
10mg ladostigil base ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule |
drug product excipients Placebo: Placebo comparator |
Total of all reporting groups | |
| Overall Number of Baseline Participants | 103 | 107 | 210 | |
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Baseline Analysis Population Description |
103 were randomized to ladostigil, however 1 subject withdrew consent before first dose.
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 103 participants | 107 participants | 210 participants | |
| <=18 years |
0 0.0%
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0 0.0%
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0 0.0%
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| Between 18 and 65 years |
15 14.6%
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16 15.0%
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31 14.8%
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| >=65 years |
88 85.4%
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91 85.0%
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179 85.2%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 103 participants | 107 participants | 210 participants | |
| 71.3 (6.3) | 71.4 (6.8) | 71.35 (6.54) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 103 participants | 107 participants | 210 participants | |
| Female |
36 35.0%
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41 38.3%
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77 36.7%
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| Male |
67 65.0%
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66 61.7%
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133 63.3%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 103 participants | 107 participants | 210 participants |
| Austria | 23 | 24 | 47 | |
| Israel | 47 | 50 | 97 | |
| Germany | 33 | 33 | 66 | |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
| Name/Title: | Jonathan Rabinowitz, PhD |
| Organization: | Bar Ilan University |
| Phone: | +972544643889 |
| EMail: | Jonathan.Rabinowitz@biu.ac.il |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Avraham Pharmaceuticals Ltd |
| ClinicalTrials.gov Identifier: | NCT01429623 |
| Other Study ID Numbers: |
CO17730 2011-004187-30 ( EudraCT Number ) |
| First Submitted: | September 3, 2011 |
| First Posted: | September 7, 2011 |
| Results First Submitted: | January 31, 2017 |
| Results First Posted: | June 15, 2017 |
| Last Update Posted: | June 15, 2017 |