Safety and Efficacy Study of Ladostigil in Mild to Moderate Probable Alzheimer's Disease
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ClinicalTrials.gov Identifier: NCT01354691 |
Recruitment Status :
Completed
First Posted : May 17, 2011
Results First Posted : July 30, 2020
Last Update Posted : July 30, 2020
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Conditions |
Alzheimer's Disease Dementia Memory Loss Cognitive Impairment |
Intervention |
Drug: ladostigil hemitartrate |
Enrollment | 200 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Ladostigil Hemitartrate | Placebo |
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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 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. |
Period Title: Overall Study | ||
Started | 101 | 99 |
ITT | 99 | 96 |
PP | 79 | 75 |
Completed | 80 | 77 |
Not Completed | 21 | 22 |
Arm/Group Title | Ladostigil Hemitartrate | Placebo | Total | |
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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 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 of all reporting groups | |
Overall Number of Baseline Participants | 101 | 99 | 200 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 101 participants | 99 participants | 200 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 14.9%
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15 15.2%
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30 15.0%
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>=65 years |
86 85.1%
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84 84.8%
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170 85.0%
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 101 participants | 99 participants | 200 participants | |
74.25 (6.73) | 74.28 (6.92) | 74.26 (6.8) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 101 participants | 99 participants | 200 participants | |
Female |
56 55.4%
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60 60.6%
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116 58.0%
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Male |
45 44.6%
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39 39.4%
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84 42.0%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Ethnicity | Number Analyzed | 101 participants | 99 participants | 200 participants |
White or Caucasian |
101 100.0%
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99 100.0%
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200 100.0%
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Other |
0 0.0%
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0 0.0%
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0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 101 participants | 99 participants | 200 participants |
Austria | 28 | 27 | 55 | |
Serbia | 4 | 2 | 6 | |
Germany | 9 | 8 | 17 | |
Croatia | 44 | 45 | 89 | |
Spain | 16 | 17 | 33 |
Name/Title: | Jonathan Rabinowitz, PhD |
Organization: | Bar Ilan University |
EMail: | jonathan.rabinowitz@biu.ac.il |
Responsible Party: | Avraham Pharmaceuticals Ltd |
ClinicalTrials.gov Identifier: | NCT01354691 |
Other Study ID Numbers: |
CR100101/CO15570 |
First Submitted: | May 1, 2011 |
First Posted: | May 17, 2011 |
Results First Submitted: | July 2, 2018 |
Results First Posted: | July 30, 2020 |
Last Update Posted: | July 30, 2020 |