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Safety, Tolerability, and Pharmacokinetic Study of EVP-6124 in Patients With Alzheimer's Disease

This study has been completed.
Sponsor:
Collaborator:
INC Research
Information provided by (Responsible Party):
EnVivo Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00766363
First received: October 1, 2008
Last updated: April 18, 2012
Last verified: April 2012
History of Changes
Results First Received: June 16, 2011  
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
Conditions: Alzheimer's Disease
Central Nervous System Diseases
Interventions: Drug: EVP-6124 (0.1 mg/day)
Drug: EVP-6124 (0.3 mg/day)
Drug: EVP-6124 (1.0 mg/day)
Drug: Comparator: Placebo
Drug: Donepezil
Drug: Rivastigmine

  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
The recruitment period was from September 2008 to February 2009 at 4 study centers in the US (CA, FL, and 2 in NJ).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
61 subjects were screened and 49 subjects were enrolled.

Reporting Groups
  Description
EVP-6124 (0.1 mg/Day) 1 capsule per day for 28 days.
EVP-6124 (0.3 mg/Day) 1 capsule per day for 28 days.
EVP-6124 (1.0 mg/Day) 1 capsule per day for 28 days.
Placebo 1 capsule per day for 28 days.

Participant Flow:   Overall Study
    EVP-6124 (0.1 mg/Day)     EVP-6124 (0.3 mg/Day)     EVP-6124 (1.0 mg/Day)     Placebo  
STARTED     12     13     12 [1]   12 [1]
SAFETY POPULATION     12     13     11 [2]   13 [3]
PK POPULATION     12     13     10     13  
COMPLETED     11     12     12     12  
NOT COMPLETED     1     1     0     0  
Withdrawal by Subject                 1                 0                 0                 0  
Adverse Event Prior to Randomization                 0                 1                 0                 0  
[1] Number randomized.
[2] Decreased by one subject who took placebo instead due to treatment assignment error.
[3] Increased by one subject who took placebo due to treatment assignment error.



  Baseline Characteristics
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Reporting Groups
  Description
EVP-6124 (0.1 mg/Day) 1 capsule per day for 28 days.
EVP-6124 (0.3 mg/Day) 1 capsule per day for 28 days.
EVP-6124 (1.0 mg/Day) 1 capsule per day for 28 days.
Placebo 1 capsule per day for 28 days.
Total Total of all reporting groups

Baseline Measures
    EVP-6124 (0.1 mg/Day)     EVP-6124 (0.3 mg/Day)     EVP-6124 (1.0 mg/Day)     Placebo     Total  
Number of Participants  
[units: participants]
 		  12     13     11     13     49  
Age  
[units: participants]
 		         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     5     5     4     4     18  
>=65 years     7     8     7     9     31  
Age  
[units: years]
Mean ± Standard Deviation 		  68.6  ± 8.5     68.3  ± 11.1     70.2  ± 12.3     72.0  ± 10.5     69.8  ± 10.4  
Gender  
[units: participants]
 		         
Female     8     7     6     8     29  
Male     4     6     5     5     20  
Region of Enrollment  
[units: participants]
 		         
United States     12     13     11     13     49  



  Outcome Measures
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1.  Primary:   Safety and Tolerability of Multiple Doses of EVP-6124 or Placebo in Subjects With Alzheimer’s Disease   [ Time Frame: Pre-treatment (Day -2) [or screening for physical examination] to Day 28 [or Day 35, for AEs only] ]
  Show Outcome Measure 1

2.  Secondary:   EVP-6124 PK Data Following the First Dose of EVP-6124 – Maximum Concentration (Cmax)   [ Time Frame: 24 hours ]
  Show Outcome Measure 2

3.  Secondary:   EVP-6124 PK Data Following the First Dose of EVP-6124 – Time to Maximum Concentration (Tmax)   [ Time Frame: 24 hours ]
  Show Outcome Measure 3

4.  Secondary:   EVP-6124 PK Data Following the First Dose of EVP-6124 – Area Under the Curve (AUC[0-24 h])   [ Time Frame: 24 hours ]
  Show Outcome Measure 4

5.  Secondary:   Donepezil PK Data Following the First Dose of EVP-6124 – Maximum Concentration (Cmax)   [ Time Frame: 24 hours ]
  Show Outcome Measure 5

6.  Secondary:   Donepezil PK Data Following the First Dose of EVP-6124 – Time to Maximum Concentration (Tmax)   [ Time Frame: 24 hours ]
  Hide Outcome Measure 6

Measure Type Secondary
Measure Title Donepezil PK Data Following the First Dose of EVP-6124 – Time to Maximum Concentration (Tmax)
Measure Description Donepezil PK data; Time to Maximum Concentration (Tmax); i.e, amount of time required to reach highest concentration of donepezil (parent compound only) in plasma after dosing with EVP-6124
Time Frame 24 hours  
Safety Issue No  

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.
PK Population: All safety population subjects who had sufficient plasma concentration data to facilitate calculation of PK parameters.

Reporting Groups
  Description
EVP-6124 (0.1 mg/Day) 1 capsule per day for 28 days.
EVP-6124 (0.3 mg/Day) 1 capsule per day for 28 days.
EVP-6124 (1.0 mg/Day) 1 capsule per day for 28 days.
Placebo 1 capsule per day for 28 days.

Measured Values
    EVP-6124 (0.1 mg/Day)     EVP-6124 (0.3 mg/Day)     EVP-6124 (1.0 mg/Day)     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  10     12     7     13  
Donepezil PK Data Following the First Dose of EVP-6124 – Time to Maximum Concentration (Tmax)  
[units: hours]
Mean ± Standard Deviation 		  2.30  ± 2.65     1.85  ± 2.15     3.31  ± 3.01     3.56  ± 4.02  

No statistical analysis provided for Donepezil PK Data Following the First Dose of EVP-6124 – Time to Maximum Concentration (Tmax)



7.  Secondary:   Donepezil PK Data Following the First Dose of EVP-6124 – Area Under the Curve (AUC[0-24 h])   [ Time Frame: 24 hours ]
  Show Outcome Measure 7

8.  Secondary:   Rivastigmine PK Data Following the First Dose of EVP-6124 - Maximum Concentration (Cmax)   [ Time Frame: 24 hours ]
  Show Outcome Measure 8

9.  Secondary:   Rivastigmine PK Data Following the First Dose of EVP-6124 - Time to Maximum Concentration (Tmax)   [ Time Frame: 24 hours ]
  Show Outcome Measure 9

10.  Secondary:   Rivastigmine PK Data Following the First Dose of EVP-6124 - Area Under the Curve (AUC[0-24 h])   [ Time Frame: 24 hours ]
  Show Outcome Measure 10


  Serious Adverse Events
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  Other Adverse Events
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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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
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.  


Results Point of Contact:  
Name/Title: Maria Gawryl, Ph.D., Vice President, Regulatory Affairs & Drug Development
Organization: EnVivo Pharmaceuticals, Inc.
phone: 617-225-4264
e-mail: mgawryl@envivopharma.com


No publications provided


Responsible Party: EnVivo Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00766363     History of Changes
Other Study ID Numbers: EVP-6124-007
Study First Received: October 1, 2008
Results First Received: June 16, 2011
Last Updated: April 18, 2012
Health Authority: United States: Food and Drug Administration