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A 3 Year Study to Evaluate the Safety and Efficacy of Low Dose Ladostigil in Patients With Mild Cognitive Impairment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01429623
First Posted: September 7, 2011
Last Update Posted: June 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Avraham Pharmaceuticals Ltd
Results First Submitted: January 31, 2017  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment between Feb. 17, 2012 and August 1, 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    Ladostigil Hemitartrate   Placebo Control
STARTED   102 [1]   107 [2] 
Converted to Alzheimer's [3]   14 [4]   21 [5] 
COMPLETED   51   48 
NOT COMPLETED   51   59 
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 
[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



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
103 were randomized to ladostigil, however 1 subject withdrew consent before first dose.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
   Ladostigil Hemitartrate   Placebo Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 103   107   210 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      15  14.6%      16  15.0%      31  14.8% 
>=65 years      88  85.4%      91  85.0%      179  85.2% 
Age 
[Units: Years]
Mean (Standard Deviation)
 71.3  (6.3)   71.4  (6.8)   71.35  (6.54) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      36  35.0%      41  38.3%      77  36.7% 
Male      67  65.0%      66  61.7%      133  63.3% 
Region of Enrollment 
[Units: Participants]
     
Austria   23   24   47 
Israel   47   50   97 
Germany   33   33   66 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Conversion From Mild Cognitive Impairment to Alzheimer's Disease Compared to Placebo   [ Time Frame: 3,6,12,18,24,30 and 36 months ]

2.  Secondary:   Change in Geriatric Depression Scale for Ladostigil Versus Placebo Population   [ Time Frame: 3,6,12,18,24,30 and 36 months ]

3.  Secondary:   Change in Neuropsychiatric Test Battery for Ladostigil Versus Placebo Population   [ Time Frame: 3,6,12,18,24,30 and 36 months ]

4.  Secondary:   Change in Disability Assessment in Dementia for Ladostigil Versus Placebo Population   [ Time Frame: 3,6,12,18,24,30 and 36 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jonathan Rabinowitz, PhD
Organization: Bar Ilan University
phone: +972544643889
e-mail: Jonathan.Rabinowitz@biu.ac.il


Publications:

Responsible Party: Avraham Pharmaceuticals Ltd
ClinicalTrials.gov Identifier: NCT01429623     History of Changes
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