An Efficacy and Safety Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease (AMARANTH)
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ClinicalTrials.gov Identifier: NCT02245737 |
Recruitment Status :
Terminated
(An independent assessment concluded the trial was not likely to meet the primary endpoint upon completion and therefore, trial stopped for futility)
First Posted : September 22, 2014
Results First Posted : August 6, 2019
Last Update Posted : December 3, 2019
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Sponsor:
AstraZeneca
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
AstraZeneca
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment |
Condition |
Alzheimer´s Disease |
Interventions |
Drug: Lanabecestat Drug: Placebo |
Enrollment | 2218 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Placebo | Lanabecestat 20 Milligrams (mg) | Lanabecestat 50 mg |
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Participants received placebo film-coated oral tablets once daily. | Participants received lanabecestat 20 mg film-coated oral tablets once daily. | Participants received lanabecestat 50 mg film-coated oral tablets once daily. |
Period Title: Overall Study | |||
Started | 740 | 739 | 739 |
Received at Least 1 Dose of Study Drug | 738 | 736 | 735 |
Completed | 187 | 184 | 168 |
Not Completed | 553 | 555 | 571 |
Reason Not Completed | |||
Adverse Event | 23 | 26 | 33 |
Condition Worsened | 9 | 10 | 9 |
Death | 2 | 4 | 4 |
Eligibility Criteria No Longer Met | 2 | 4 | 4 |
Initiation of Symptomatic AD medication | 2 | 0 | 0 |
Lost to Follow-up | 2 | 5 | 4 |
Other-determined by Investigator | 9 | 10 | 10 |
Physician Decision | 6 | 3 | 6 |
Protocol Violation | 3 | 2 | 3 |
Withdrawal by Subject | 40 | 41 | 44 |
Withdrawal due to Caregiver Circumstance | 10 | 20 | 22 |
Sponsor Decision | 445 | 430 | 432 |
Baseline Characteristics
Arm/Group Title | Placebo | Lanabecestat 20 mg | Lanabecestat 50 mg | Total | |
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Participants received placebo film-coated oral tablets once daily. | Participants received lanabecestat 20 mg film-coated oral tablets once daily. | Participants received lanabecestat 50 mg film-coated oral tablets once daily. | Total of all reporting groups | |
Overall Number of Baseline Participants | 740 | 739 | 739 | 2218 | |
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All randomized participants
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 740 participants | 739 participants | 739 participants | 2218 participants | |
71.4 (6.9) | 71.2 (7.5) | 71.2 (7.0) | 71.3 (7.1) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 740 participants | 739 participants | 739 participants | 2218 participants | |
Female |
398 53.8%
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395 53.5%
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384 52.0%
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1177 53.1%
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Male |
342 46.2%
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344 46.5%
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355 48.0%
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1041 46.9%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 740 participants | 739 participants | 739 participants | 2218 participants | |
Hispanic or Latino |
43 5.8%
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26 3.5%
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24 3.2%
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93 4.2%
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Not Hispanic or Latino |
626 84.6%
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650 88.0%
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644 87.1%
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1920 86.6%
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Unknown or Not Reported |
71 9.6%
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63 8.5%
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71 9.6%
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205 9.2%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 740 participants | 739 participants | 739 participants | 2218 participants | |
American Indian or Alaska Native |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Asian |
85 11.5%
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85 11.5%
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102 13.8%
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272 12.3%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Black or African American |
5 0.7%
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5 0.7%
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6 0.8%
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16 0.7%
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White |
598 80.8%
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609 82.4%
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593 80.2%
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1800 81.2%
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More than one race |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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Unknown or Not Reported |
52 7.0%
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40 5.4%
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38 5.1%
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130 5.9%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 740 participants | 739 participants | 739 participants | 2218 participants |
Puerto Rico |
13 1.8%
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11 1.5%
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12 1.6%
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36 1.6%
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Romania |
1 0.1%
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2 0.3%
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2 0.3%
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5 0.2%
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Hungary |
7 0.9%
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12 1.6%
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6 0.8%
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25 1.1%
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United States |
171 23.1%
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171 23.1%
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179 24.2%
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521 23.5%
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Japan |
48 6.5%
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57 7.7%
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78 10.6%
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183 8.3%
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United Kingdom |
85 11.5%
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87 11.8%
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78 10.6%
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250 11.3%
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Spain |
74 10.0%
|
77 10.4%
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65 8.8%
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216 9.7%
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Canada |
58 7.8%
|
59 8.0%
|
63 8.5%
|
180 8.1%
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South Korea |
30 4.1%
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24 3.2%
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16 2.2%
|
70 3.2%
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Belgium |
20 2.7%
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15 2.0%
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15 2.0%
|
50 2.3%
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Poland |
58 7.8%
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51 6.9%
|
50 6.8%
|
159 7.2%
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Italy |
45 6.1%
|
38 5.1%
|
49 6.6%
|
132 6.0%
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Australia |
38 5.1%
|
55 7.4%
|
38 5.1%
|
131 5.9%
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France |
45 6.1%
|
36 4.9%
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36 4.9%
|
117 5.3%
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Germany |
47 6.4%
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44 6.0%
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52 7.0%
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143 6.4%
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ADAS-Cog13 (13-item Alzheimer's Disease Assessment Scale)
[1] Mean (Standard Deviation) Unit of measure: Units on a Scale |
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Number Analyzed | 740 participants | 739 participants | 739 participants | 2218 participants | |
28.6 (7.9) | 29.0 (7.7) | 28.5 (8.2) | 28.7 (8.0) | ||
[1]
Measure Description: ADAS-Cog13, a 13-item rating scale, measured the severity of cognitive dysfunction in persons with Alzheimer's disease (AD). Scores ranged from 0 to 85, with a higher score indicating worse cognitive functioning.
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Outcome Measures
Adverse Events
Limitations and Caveats
An independent assessment concluded the trial was not likely to meet the primary endpoint upon completion and therefore, trial stopped for futility.
More Information
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 sponsor shall review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60days but less than or equal to 180days from the time submitted to the sponsor.Authors agree not to publish results until data is compiled. No publication/presentation with respect to the research activities shall be made unless & until any information determined at sponsors sole discretion to be confidential information has been removed.
Results Point of Contact
Name/Title: | AstraZeneca Information Center |
Organization: | AstraZeneca |
Phone: | 1-877-240-9479 |
EMail: | information.center@astrazeneca.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT02245737 |
Other Study ID Numbers: |
16023 I8D-MC-AZES ( Other Identifier: Eli Lilly and Company ) 2014-002601-38 ( EudraCT Number ) D5010C00009 ( Other Identifier: AstraZeneca ) |
First Submitted: | September 18, 2014 |
First Posted: | September 22, 2014 |
Results First Submitted: | June 11, 2019 |
Results First Posted: | August 6, 2019 |
Last Update Posted: | December 3, 2019 |