Trial Outcomes & Findings for Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer's Disease (SERENE) (NCT NCT02992132)

Last Updated: 2019-03-28

Results Overview

The Cohen-Mansfield Agitation Inventory (CMAI) is a 29-item scale to assess agitation. Each item is rated on a 7-point scale of frequency, from least (1) to most frequent (7). Items are summed to calculate the CMAI total score. The CMAI total score has a range of 29-203 points; higher scores indicate more severe agitation

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

111 participants

Primary outcome timeframe

Baseline to 12 weeks

Results posted on

2019-03-28

Participant Flow

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.

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).

Participant milestones

Participant milestones
Measure	Placebo Placebo, taken as two tablets, once daily by mouth Placebo: Placebo, taken as two tablets, once daily by mouth	Pimavanserin 20 mg 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	Pimavanserin 34 mg 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
Overall Study STARTED	40	35	36
Overall Study COMPLETED	27	27	29
Overall Study NOT COMPLETED	13	8	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Placebo, taken as two tablets, once daily by mouth Placebo: Placebo, taken as two tablets, once daily by mouth	Pimavanserin 20 mg 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	Pimavanserin 34 mg 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
Overall Study Adverse Event	4	1	3
Overall Study Lack of Efficacy	2	0	0
Overall Study Non-compliance with study drug	2	0	0
Overall Study Progressive disease	1	0	0
Overall Study Protocol Violation	2	2	0
Overall Study Caregiver withdrew consent	2	3	2
Overall Study Withdrawal by Subject	0	2	1
Overall Study Physician Decision	0	0	1

Baseline Characteristics

Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer's Disease (SERENE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=40 Participants Placebo, taken as two tablets, once daily by mouth Placebo: Placebo, taken as two tablets, once daily by mouth	Pimavanserin 20 mg n=35 Participants 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	Pimavanserin 34 mg n=36 Participants 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 n=111 Participants Total of all reporting groups
Age, Continuous	78.9 years STANDARD_DEVIATION 7.58 • n=5 Participants	76.5 years STANDARD_DEVIATION 8.74 • n=7 Participants	75.0 years STANDARD_DEVIATION 7.90 • n=5 Participants	76.8 years STANDARD_DEVIATION 8.15 • n=4 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	15 Participants n=7 Participants	18 Participants n=5 Participants	58 Participants n=4 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	20 Participants n=7 Participants	18 Participants n=5 Participants	53 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=5 Participants	16 Participants n=7 Participants	17 Participants n=5 Participants	53 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants	15 Participants n=7 Participants	18 Participants n=5 Participants	50 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants	31 Participants n=7 Participants	32 Participants n=5 Participants	99 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	9 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Population: Full Analysis set, i.e. patients who had been randomized and treated and had both a baseline value and at least 1 post-baseline value for the CMAI total score.

Outcome measures

Outcome measures
Measure	Placebo n=37 Participants Placebo, taken as two tablets, once daily by mouth Placebo: Placebo, taken as two tablets, once daily by mouth	Pimavanserin 20 mg n=34 Participants 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	Pimavanserin 34 mg n=35 Participants 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
Cohen-Mansfield Agitation Inventory (CMAI) Baseline	70.3 score on a scale Standard Error 4.5	56.9 score on a scale Standard Error 2.2	68.0 score on a scale Standard Error 3.3
Cohen-Mansfield Agitation Inventory (CMAI) Week 12	54.3 score on a scale Standard Error 4.3	52.5 score on a scale Standard Error 4.3	53.7 score on a scale Standard Error 3.0
Cohen-Mansfield Agitation Inventory (CMAI) Week 12 change from baseline	-16.8 score on a scale Standard Error 5.0	-3.7 score on a scale Standard Error 3.7	-12.3 score on a scale Standard Error 2.7

SECONDARY outcome

Timeframe: Baseline to 12 weeks

Population: Full Analysis set, i.e. patients who had been randomized and treated and had both a baseline value and at least 1 post-baseline value for the CMAI total score.

The Zarit Burden Interview (ZBI) assess the stresses experienced by caregivers of patients with dementia. It assesses 22 questions about the impact of the patient's disabilities on the caregiver's life, each rated from least (0) to most (4) frequent. Items are summed to calculate the ZBI total score. The ZBI total score ranges from 0 to 88; higher scores denoting more stresses experienced by caregivers.

Outcome measures

Outcome measures
Measure	Placebo n=34 Participants Placebo, taken as two tablets, once daily by mouth Placebo: Placebo, taken as two tablets, once daily by mouth	Pimavanserin 20 mg n=33 Participants 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	Pimavanserin 34 mg n=32 Participants 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
Zarit Burden Interview Baseline	41.5 score on a scale Standard Error 2.6	40.8 score on a scale Standard Error 2.4	41.7 score on a scale Standard Error 2.5
Zarit Burden Interview Week 12	37.0 score on a scale Standard Error 3.2	36.8 score on a scale Standard Error 3.7	35.7 score on a scale Standard Error 3.5
Zarit Burden Interview Week 12 change from baseline	-6.5 score on a scale Standard Error 2.3	-4.9 score on a scale Standard Error 2.3	-5.5 score on a scale Standard Error 2.5

Adverse Events

Placebo

Serious events: 3 serious events

Other events: 11 other events

Deaths: 0 deaths

Pimavanserin 20 mg

Serious events: 4 serious events

Other events: 15 other events

Deaths: 0 deaths

Pimavanserin 34 mg

Serious events: 3 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=40 participants at risk Placebo, taken as two tablets, once daily by mouth Placebo: Placebo, taken as two tablets, once daily by mouth	Pimavanserin 20 mg n=35 participants at risk 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	Pimavanserin 34 mg n=36 participants at risk 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
Gastrointestinal disorders Diverticulum	0.00% 0/40 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	2.9% 1/35 • Number of events 1 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	0.00% 0/36 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/40 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	2.9% 1/35 • Number of events 1 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	0.00% 0/36 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)
Gastrointestinal disorders Upper gastrointestinal haemorrhage	2.5% 1/40 • Number of events 1 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	0.00% 0/35 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	0.00% 0/36 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)
Infections and infestations Sepsis	0.00% 0/40 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	2.9% 1/35 • Number of events 1 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	0.00% 0/36 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)
Injury, poisoning and procedural complications Femoral neck fracture	0.00% 0/40 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	2.9% 1/35 • Number of events 1 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	0.00% 0/36 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)
Injury, poisoning and procedural complications Pelvic fracture	0.00% 0/40 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	0.00% 0/35 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	2.8% 1/36 • Number of events 1 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)
Investigations Weight decreased	2.5% 1/40 • Number of events 1 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	0.00% 0/35 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	0.00% 0/36 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/40 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	2.9% 1/35 • Number of events 1 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	0.00% 0/36 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)
Nervous system disorders Encephalopathy	0.00% 0/40 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	2.9% 1/35 • Number of events 1 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	0.00% 0/36 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)
Psychiatric disorders Agitation	0.00% 0/40 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	2.9% 1/35 • Number of events 1 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	5.6% 2/36 • Number of events 2 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	2.5% 1/40 • Number of events 1 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	0.00% 0/35 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	0.00% 0/36 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)

Other adverse events

Other adverse events
Measure	Placebo n=40 participants at risk Placebo, taken as two tablets, once daily by mouth Placebo: Placebo, taken as two tablets, once daily by mouth	Pimavanserin 20 mg n=35 participants at risk 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	Pimavanserin 34 mg n=36 participants at risk 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
Blood and lymphatic system disorders Anaemia	2.5% 1/40 • Number of events 1 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	5.7% 2/35 • Number of events 2 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	0.00% 0/36 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)
Gastrointestinal disorders Diarrhoea	7.5% 3/40 • Number of events 3 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	5.7% 2/35 • Number of events 2 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	5.6% 2/36 • Number of events 2 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)
Gastrointestinal disorders Constipation	2.5% 1/40 • Number of events 1 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	5.7% 2/35 • Number of events 2 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	5.6% 2/36 • Number of events 2 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/40 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	5.7% 2/35 • Number of events 2 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	0.00% 0/36 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)
Infections and infestations Nasopharyngitis	2.5% 1/40 • Number of events 1 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	0.00% 0/35 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	5.6% 2/36 • Number of events 2 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)
Infections and infestations Urinary tract infection	0.00% 0/40 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	5.7% 2/35 • Number of events 2 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	2.8% 1/36 • Number of events 1 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)
Injury, poisoning and procedural complications Fall	2.5% 1/40 • Number of events 1 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	8.6% 3/35 • Number of events 3 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	8.3% 3/36 • Number of events 3 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)
Injury, poisoning and procedural complications Contusion	2.5% 1/40 • Number of events 1 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	2.9% 1/35 • Number of events 2 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	5.6% 2/36 • Number of events 2 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)
Metabolism and nutrition disorders Decreased appetite	0.00% 0/40 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	5.7% 2/35 • Number of events 2 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	5.6% 2/36 • Number of events 2 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)
Psychiatric disorders Agitation	12.5% 5/40 • Number of events 5 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	14.3% 5/35 • Number of events 5 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	2.8% 1/36 • Number of events 1 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)
Psychiatric disorders Insomnia	0.00% 0/40 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	11.4% 4/35 • Number of events 5 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)	8.3% 3/36 • Number of events 3 • From the time of informed consent through the completion of procedures at the Week 12 visit (for subjects continuing into an Open-Label Extension study) or through to 30 days after the last dose of study drug (for all other subjects)

Additional Information

Sr. Dir. Medical Information and Medical Communications

ACADIA Pharmaceuticals Inc.

Phone: 858-261-2897

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Investigator may publish the study results, relative to his/her own patients, only after review, comment and approval by the sponsor. No publication of confidential information shall be made without the sponsor's prior written consent. At least 60 days prior to submitting a manuscript or prior to any public presentation, a copy of the manuscript or presentation will be provided to the sponsor for review and comment. The sponsor has 60 days to review and comment.
Publication restrictions are in place

Restriction type: OTHER