Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer's Disease (SERENE)
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ClinicalTrials.gov Identifier: NCT02992132 |
Recruitment Status :
Terminated
First Posted : December 14, 2016
Results First Posted : March 28, 2019
Last Update Posted : March 28, 2019
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Agitation and Aggression in Alzheimer's Disease |
Interventions |
Drug: Pimavanserin 34 mg Drug: Pimavanserin 20 mg Other: Placebo |
Enrollment | 111 |
Recruitment Details | The study was planned to be conducted in approximately 432 subjects. For business reasons, and not related to safety, recruitment of subjects was stopped after 111 subjects were randomized. The last subject was randomized on 2 Nov 2017. |
Pre-assignment Details | The screening visit was followed by a 2- to 4-week screening period, including wash-out of antipsychotic agents which were prohibited during the Treatment period (exception: protocol specified agents). Subjects had to be on stable doses of permitted medications for >=4 weeks before Baseline (>=12 weeks for cholinesterase inhibitors and memantine). |
Arm/Group Title | Placebo | Pimavanserin 20 mg | Pimavanserin 34 mg |
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Placebo, taken as two tablets, once daily by mouth Placebo: Placebo, taken as two tablets, once daily by mouth |
Drug- pimavanserin tartrate, 20 mg, taken as two 10 mg tablets, once daily by mouth Pimavanserin 20 mg: Pimavanserin 20 mg, tablet, taken as two 10 mg tablets, once daily by mouth |
Drug- pimavanserin tartrate, 34 mg, taken as two 17 mg tablets, once daily by mouth Pimavanserin 34 mg: Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth |
Period Title: Overall Study | |||
Started | 40 | 35 | 36 |
Completed | 27 | 27 | 29 |
Not Completed | 13 | 8 | 7 |
Reason Not Completed | |||
Adverse Event | 4 | 1 | 3 |
Lack of Efficacy | 2 | 0 | 0 |
Non-compliance with study drug | 2 | 0 | 0 |
Progressive disease | 1 | 0 | 0 |
Protocol Violation | 2 | 2 | 0 |
Caregiver withdrew consent | 2 | 3 | 2 |
Withdrawal by Subject | 0 | 2 | 1 |
Physician Decision | 0 | 0 | 1 |
Arm/Group Title | Placebo | Pimavanserin 20 mg | Pimavanserin 34 mg | Total | |
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Placebo, taken as two tablets, once daily by mouth Placebo: Placebo, taken as two tablets, once daily by mouth |
Drug- pimavanserin tartrate, 20 mg, taken as two 10 mg tablets, once daily by mouth Pimavanserin 20 mg: Pimavanserin 20 mg, tablet, taken as two 10 mg tablets, once daily by mouth |
Drug- pimavanserin tartrate, 34 mg, taken as two 17 mg tablets, once daily by mouth Pimavanserin 34 mg: Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth |
Total of all reporting groups | |
Overall Number of Baseline Participants | 40 | 35 | 36 | 111 | |
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All patients randomized
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 40 participants | 35 participants | 36 participants | 111 participants | |
78.9 (7.58) | 76.5 (8.74) | 75.0 (7.90) | 76.8 (8.15) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 40 participants | 35 participants | 36 participants | 111 participants | |
Female |
25 62.5%
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15 42.9%
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18 50.0%
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58 52.3%
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Male |
15 37.5%
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20 57.1%
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18 50.0%
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53 47.7%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 40 participants | 35 participants | 36 participants | 111 participants | |
Hispanic or Latino |
20 50.0%
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16 45.7%
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17 47.2%
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53 47.7%
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Not Hispanic or Latino |
17 42.5%
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15 42.9%
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18 50.0%
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50 45.0%
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Unknown or Not Reported |
3 7.5%
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4 11.4%
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1 2.8%
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8 7.2%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 40 participants | 35 participants | 36 participants | 111 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 |
0 0.0%
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0 0.0%
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2 5.6%
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2 1.8%
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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 |
1 2.5%
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0 0.0%
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0 0.0%
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1 0.9%
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White |
36 90.0%
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31 88.6%
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32 88.9%
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99 89.2%
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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 |
3 7.5%
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4 11.4%
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2 5.6%
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9 8.1%
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Name/Title: | Sr. Dir. Medical Information and Medical Communications |
Organization: | ACADIA Pharmaceuticals Inc. |
Phone: | 858-261-2897 |
EMail: | medicalinformation@acadia-pharm.com |
Responsible Party: | ACADIA Pharmaceuticals Inc. |
ClinicalTrials.gov Identifier: | NCT02992132 |
Other Study ID Numbers: |
ACP-103-032 2016-001127-32 ( EudraCT Number ) |
First Submitted: | December 12, 2016 |
First Posted: | December 14, 2016 |
Results First Submitted: | January 25, 2019 |
Results First Posted: | March 28, 2019 |
Last Update Posted: | March 28, 2019 |