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Trial record 7 of 7 for:    LY2886721

Study of LY2886721 in Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease

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.
ClinicalTrials.gov Identifier: NCT01561430
Recruitment Status : Terminated (Study terminated due to abnormal liver biochemical tests in some participants.)
First Posted : March 23, 2012
Results First Posted : May 18, 2018
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Basic Science
Condition: Alzheimer's Disease
Interventions: Drug: LY2886721
Drug: Placebo

  Participant Flow

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
As a result of findings from the I4O-MC-BACJ study (NCT01534273), enrollment was discontinued to the 15 milligrams (mg) arm. The 9 participants already enrolled were allowed to continue study treatment at the 15 mg dose.

Reporting Groups
  Description
15 mg LY2886721 LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.
35 mg LY2886721 LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
70 mg LY2886721 LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
Placebo Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.

Participant Flow:   Overall Study
    15 mg LY2886721   35 mg LY2886721   70 mg LY2886721   Placebo
STARTED   9   23   18   20 
Received at Least One Dose of Study Drug   9   23   18   20 
COMPLETED   8   8   1   7 
NOT COMPLETED   1   15   17   13 
Adverse Event                0                0                3                1 
Withdrawal by Subject                0                0                1                0 
Physician Decision                0                1                0                0 
Sponsor Decision                1                14                13                12 



  Baseline Characteristics

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.
All enrolled participants.

Reporting Groups
  Description
15 mg LY2886721 LY2886721: 15 milligrams (mg), capsules, administered orally, once daily for 26 weeks.
35 mg LY2886721 LY2886721: 35 mg, capsules, administered orally, once daily for 26 weeks.
70 mg LY2886721 LY2886721: 70 mg, capsules, administered orally, once daily for 26 weeks.
Placebo Placebo: 1 placebo capsule, administered orally, once daily for 26 weeks.
Total Total of all reporting groups

Baseline Measures
   15 mg LY2886721   35 mg LY2886721   70 mg LY2886721   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   23   18   20   70 
Age 
[Units: Years]
Mean (Standard Deviation)
 65.59  (7.569)   72.50  (8.378)   70.23  (8.603)   67.73  (7.126)   69.66  (8.201) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      5  55.6%      10  43.5%      7  38.9%      11  55.0%      33  47.1% 
Male      4  44.4%      13  56.5%      11  61.1%      9  45.0%      37  52.9% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
         
American Indian or Alaska Native   0   0   0   0   0 
Asian   0   3   3   0   6 
Black or African American   0   0   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0   0   0 
White   9   20   15   20   64 
Region of Enrollment 
[Units: Participants]
Count of Participants
         
United States   8   19   15   18   60 
Netherlands   1   1   1   2   5 
Japan   0   3   2   0   5 


  Outcome Measures

1.  Primary:   Change From Baseline to 12 Weeks in Cerebrospinal Fluid (CSF) Amyloid Beta (Aβ)1-40 and Aβ1-42 Concentrations   [ Time Frame: Baseline, 12 weeks ]

2.  Primary:   Change From Baseline to 26 Weeks in CSF Aβ1-40 and Aβ1-42 Concentrations   [ Time Frame: Baseline, 26 weeks ]

3.  Secondary:   Change From Baseline in Plasma Amyloid Beta (Aβ)1-40 and Aβ1-42 Concentrations   [ Time Frame: Baseline, 12 weeks, 26 weeks ]

4.  Secondary:   Change From Baseline to 26 Weeks in Neuropsychological Test Battery (NTB)   [ Time Frame: Baseline, 26 weeks ]

5.  Secondary:   Change From Baseline to 26 Weeks in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)   [ Time Frame: Baseline, 26 weeks ]

6.  Secondary:   Change From Baseline to 26 Weeks in the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)   [ Time Frame: Baseline, 26 weeks ]

7.  Secondary:   Change From Baseline to 26 Weeks in Mini Mental State Examination (MMSE)   [ Time Frame: Baseline, 26 weeks ]

8.  Secondary:   Change From Baseline in Cerebrospinal Fluid (CSF) Tau and Phosphorylated Tau (Ptau)-181 Concentrations   [ Time Frame: Baseline, 12 weeks, 26 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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
Study was terminated early because of abnormal liver biochemical tests levels for 4 participants.


  More Information

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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979



Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01561430     History of Changes
Other Study ID Numbers: 13735
I4O-MC-BACC ( Other Identifier: Eli Lilly and Company )
2011-005217-37 ( EudraCT Number )
First Submitted: March 21, 2012
First Posted: March 23, 2012
Results First Submitted: March 24, 2018
Results First Posted: May 18, 2018
Last Update Posted: May 18, 2018