Trial · NCT02035553

A Study of the Safety and Efficacy of Pimavanserin in Patients With Alzheimer's Disease Psychosis

NCT02035553, Phase 2, Completed, ACADIA Pharmaceuticals Inc.; results first posted 2017-10-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study of the Safety and Efficacy of Pimavanserin in Patients With Alzheimer's Disease Psychosis. Trials, record NCT02035553. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02035553

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Trial

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

Title: A Study of the Safety and Efficacy of Pimavanserin in Patients With Alzheimer's Disease Psychosis
NCT number: NCT02035553
Status: Completed
Phases: Phase 2
Enrollment: 181 participants, actual
Lead sponsor: ACADIA Pharmaceuticals Inc.
Conditions: Alzheimer's Disease Psychosis
Interventions: Pimavanserin tartrate, Placebo
First posted: 2014-01-14
Last updated: 2017-10-25
Results first posted: 2017-10-25

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Antipsychotic Efficacy	Day 43	Change from Baseline to Day 43 in the Neuropsychiatric Inventory-Nursing Home Version (NPI-NH) psychosis score (Delusions \[Domain A\]+Hallucinations \[Domain B\]) in the Full Analysis Set (FAS). The NPI-NH is a questionnaire that quantifies behavioral changes in dementia in nursing home patients and evaluates 12 behavioral domains. For each of the 12 behavioral domains the Frequency (scale:1=occasionally to 4=very frequently) is multiplied by the Severity (scale:1=Mild to 3=Severe) to obtain a domain score (frequency x severity), The NPI-NH Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual domain scores, to yield a possible total score of 0 to 24. Lower scores correspond to less severity. A negative change score from baseline indicates improvement.

Source ClinicalTrials.gov

Outcomes1

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Antipsychotic Efficacy	Day 43	All randomized subjects who received at least one dose of study treatment and have both a Baseline and at least one post-Baseline NPI-NH psychosis score evaluation.	Score on the NPI-NH scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group2

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

Outcome	Group	Category	Value	Spread	Units
Antipsychotic Efficacy	Placebo		-1.93	95% Confidence Interval -3.18 to -0.67	Score on the NPI-NH scale
Antipsychotic Efficacy	Pimavanserin 40 mg		-3.76	95% Confidence Interval -5.05 to -2.47	Score on the NPI-NH 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	91
Overall Study	STARTED	Pimavanserin 40 mg	90
Overall Study	COMPLETED	Placebo	73
Overall Study	COMPLETED	Pimavanserin 40 mg	67
Overall Study	NOT COMPLETED	Placebo	18
Overall Study	NOT COMPLETED	Pimavanserin 40 mg	23

Source ClinicalTrials.gov

Adverse events82

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	Anaemia	Blood and lymphatic system disorders	Placebo	8	91	8
other	Anaemia	Blood and lymphatic system disorders	Pimavanserin 40 mg	9	90	9
other	Oedema peripheral	General disorders	Placebo	2	91	2
other	Oedema peripheral	General disorders	Pimavanserin 40 mg	7	90	7
other	Urinary tract infection	Infections and infestations	Placebo	25	91	36
other	Urinary tract infection	Infections and infestations	Pimavanserin 40 mg	18	90	27
other	Lower respiratory tract infection	Infections and infestations	Placebo	12	91	13
other	Lower respiratory tract infection	Infections and infestations	Pimavanserin 40 mg	13	90	15
other	Cellulitis	Infections and infestations	Placebo	3	91	3
other	Cellulitis	Infections and infestations	Pimavanserin 40 mg	6	90	7

1 to 10 of 82Source ClinicalTrials.gov

See all 82 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	4	91
Total, all-cause mortality	Pimavanserin 40 mg	4	90
Total, other adverse events	Placebo	70	91
Total, other adverse events	Pimavanserin 40 mg	67	90
Total, serious adverse events	Placebo	10	91
Total, serious adverse events	Pimavanserin 40 mg	15	90

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
29452684	DERIVED	PubMed
34918337	DERIVED	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 comparisons2

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

Comparison	Source
Pimavanserin 40 mg vs Placebo: deaths from any cause	Trial comparisons
Pimavanserin 40 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/NCT02035553

GET https://conductscience.org/api/trials/v1/NCT02035553/events?page=2

API reference For AI assistants