Evaluation of Safety & Tolerability of Multiple Dose Regimens of CHF 5074 (CT04)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CERESPIR
ClinicalTrials.gov Identifier:
NCT01303744
First received: February 23, 2011
Last updated: December 2, 2015
Last verified: December 2015
Results First Received: October 16, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Alzheimer's Disease
Interventions: Drug: CHF 5074 1x
Drug: CHF 5074 2x
Drug: CHF 5074 3x
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
No text entered.

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
CHF 5074 1x

oral tablet, multidose

CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks

CHF 5074 2x

oral tablet, multidose

CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks

CHF 5074 3x

oral tablet, multidose

CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks

Placebo

placebo, oral tablet, multidose

Placebo: oral tablet, once a day in the morning for 12 weeks


Participant Flow:   Overall Study
    CHF 5074 1x     CHF 5074 2x     CHF 5074 3x     Placebo  
STARTED     24     24     24     24  
COMPLETED     24     24     24     24  
NOT COMPLETED     0     0     0     0  



  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.
No text entered.

Reporting Groups
  Description
CHF 5074 1x

oral tablet, multidose

CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks

CHF 5074 2x

oral tablet, multidose

CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks

CHF 5074 3x

oral tablet, multidose

CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks

Placebo

placebo, oral tablet, multidose

Placebo: oral tablet, once a day in the morning for 12 weeks

Total Total of all reporting groups

Baseline Measures
    CHF 5074 1x     CHF 5074 2x     CHF 5074 3x     Placebo     Total  
Number of Participants  
[units: participants]
  24     24     24     24     96  
Age  
[units: years]
Mean (Standard Deviation)
  67.7  (8.1)     68.9  (8.5)     69.0  (9.2)     68.1  (8.0)     68.4  (8.3)  
Gender  
[units: participants]
         
Female     10     11     11     8     40  
Male     14     13     13     16     56  
Race (NIH/OMB)  
[units: participants]
         
American Indian or Alaska Native     0     0     0     0     0  
Asian     0     1     0     1     2  
Native Hawaiian or Other Pacific Islander     0     0     0     0     0  
Black or African American     1     1     0     0     2  
White     23     22     24     23     92  
More than one race     0     0     0     0     0  
Unknown or Not Reported     0     0     0     0     0  
Region of Enrollment  
[units: participants]
         
United States     24     24     19     24     91  
Italy     0     0     5     0     5  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Differences in ∆sCD40L Levels Between CHF 5074 Doses and Placebo at Any Specific Time Point   [ Time Frame: up to 12 weeks ]

2.  Secondary:   Measurement of Trough CHF 5074 Plasma Levels   [ Time Frame: Days 85 ]

3.  Secondary:   Changes in Plasma ΔTNFα Concentrations   [ Time Frame: 29 days ]


  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
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  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: Richard Margolin
Organization: Cerespir
phone: (646) 202-2562
e-mail: rmargolin@cerespir.com


No publications provided


Responsible Party: CERESPIR
ClinicalTrials.gov Identifier: NCT01303744     History of Changes
Other Study ID Numbers: CCD-1014-PR-0053
2010-024270-19 ( EudraCT Number )
Study First Received: February 23, 2011
Results First Received: October 16, 2015
Last Updated: December 2, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Italy: Ethics Committee