Trial · NCT03575052

A Safety Study of Pimavanserin in Adult and Elderly Subjects Experiencing Neuropsychiatric Symptoms Related to Neurodegenerative Disease

NCT03575052, Phase 3, Completed, ACADIA Pharmaceuticals Inc.; results first posted 2024-12-31

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Safety Study of Pimavanserin in Adult and Elderly Subjects Experiencing Neuropsychiatric Symptoms Related to Neurodegenerative Disease. Trials, record NCT03575052. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03575052

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Safety Study of Pimavanserin in Adult and Elderly Subjects Experiencing Neuropsychiatric Symptoms Related to Neurodegenerative Disease
NCT number: NCT03575052
Status: Completed
Phases: Phase 3
Enrollment: 784 participants, actual
Lead sponsor: ACADIA Pharmaceuticals Inc.
Conditions: Neuropsychiatric Symptoms Related to Neurodegenerative Disease
Interventions: Pimavanserin, Placebo
First posted: 2018-07-02
Last updated: 2024-12-31
Other registries' IDs: eudract:2017-003536-36
Results first posted: 2024-12-31

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Treatment-emergent Adverse Events (TEAEs)	Treatment Period: 8 weeks	Number (%) of patients with treatment-emergent AEs
Secondary	Change From Baseline to Week 8 in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A)	Treatment Period: 8 weeks	The ESRS is a questionnaire to assess drug induced movement disorders, including parkinsonism; the ESRS-A is an accepted modified form of the original ESRS. The ESRS-A consists of 4 subscales and 4 clinical global impression movement severity scales of Parkinsonism, dyskinesia, dystonia, and akathisia. The Parkinsonism scale consists of 10 items, the dyskinesia subscale of 6 items, the dystonia subscale of 6 items, and the akathisia subscale of 2 items. Each item is scored on a 6-point scale from 0 (absent) to 5 (extreme). The ESRS-A total score is the sum of the 24 item scores with a possible range of 0 to 120. Higher scores denote more severe drug-induced movement disorders.
Secondary	Change From Baseline to Week 8 in Mini-Mental State Examination (MMSE)	Treatment Period: 8 weeks	The MMSE is a 30-item questionnaire to quantitatively assess cognition, focusing on questions related to time and place of testing, repeating lists of words, arithmetic, language use and comprehension, and copying a drawing. Each of the 30 items has 2 possible values of 0 (incorrect) or 1 (correct). The MMSE total score is derived as the sum of the 30 item scores; thus, it can range from 0 to 30. Lower scores indicate more severe cognitive impairment.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Treatment-emergent Adverse Events (TEAEs)	Treatment Period: 8 weeks	All patients randomised and treated	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline to Week 8 in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A)	Treatment Period: 8 weeks	All patients randomised and treated	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to Week 8 in Mini-Mental State Examination (MMSE)	Treatment Period: 8 weeks	All patients randomised and treated	score on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Treatment-emergent Adverse Events (TEAEs)	Placebo	115		Participants
Treatment-emergent Adverse Events (TEAEs)	Pimavanserin 34 mg	119		Participants
Change From Baseline to Week 8 in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A)	Placebo	-0.6	Standard Error 0.19	score on a scale
Change From Baseline to Week 8 in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A)	Pimavanserin 34 mg	-0.5	Standard Error 0.19	score on a scale
Change From Baseline to Week 8 in Mini-Mental State Examination (MMSE)	Placebo	1.2	Standard Error 0.15	score on a scale
Change From Baseline to Week 8 in Mini-Mental State Examination (MMSE)	Pimavanserin 34 mg	1.3	Standard Error 0.15	score on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	392
Overall Study	STARTED	Pimavanserin 34 mg	392
Overall Study	COMPLETED	Placebo	367
Overall Study	COMPLETED	Pimavanserin 34 mg	363
Overall Study	NOT COMPLETED	Placebo	25
Overall Study	NOT COMPLETED	Pimavanserin 34 mg	29

Source ClinicalTrials.gov

Adverse events40

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Urinary tract infection	Infections and infestations	Placebo	16	392	16
other	Urinary tract infection	Infections and infestations	Pimavanserin 34 mg	25	392	26
serious	Arrhythmia	Cardiac disorders	Placebo	1	392	1
serious	Arrhythmia	Cardiac disorders	Pimavanserin 34 mg	0	392	0
serious	Erysipelas	Infections and infestations	Placebo	1	392	1
serious	Erysipelas	Infections and infestations	Pimavanserin 34 mg	0	392	0
serious	Pneumonia	Infections and infestations	Placebo	1	392	1
serious	Pneumonia	Infections and infestations	Pimavanserin 34 mg	0	392	0
serious	Upper respiratory tract infection	Infections and infestations	Placebo	0	392	0
serious	Upper respiratory tract infection	Infections and infestations	Pimavanserin 34 mg	1	392	1

1 to 10 of 40Source ClinicalTrials.gov

See all 40 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	2	392
Total, all-cause mortality	Pimavanserin 34 mg	2	392
Total, other adverse events	Placebo	16	392
Total, other adverse events	Pimavanserin 34 mg	25	392
Total, serious adverse events	Placebo	6	392
Total, serious adverse events	Pimavanserin 34 mg	8	392

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
38427485	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Pimavanserin 34 mg vs Placebo: Treatment-emergent Adverse Events (TEAEs)	Trial comparisons
Pimavanserin 34 mg vs Placebo: deaths from any cause	Trial comparisons
Pimavanserin 34 mg vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03575052

GET https://conductscience.org/api/trials/v1/NCT03575052/events?page=2

API reference For AI assistants