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A Study of Pimavanserin for the Treatment of Agitation and Aggression in Subjects With Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03118947
Recruitment Status : Completed
First Posted : April 18, 2017
Results First Posted : March 9, 2020
Last Update Posted : April 9, 2020
Sponsor:
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Agitation and Aggression in Alzheimer's Disease
Intervention Drug: Pimavanserin
Enrollment 79
Recruitment Details This open-label extension study included patients completing double-blind, randomised, placebo-controlled study ACP-103-032 (NCT02992132).
Pre-assignment Details Patients from parent study ACP-103-032 who were eligible to participate in this study were consented prior to the final procedures performed for study ACP-103-032 at Week 12. The ACP-103-032 Week 12 visit was also considered the baseline visit of study ACP-103-033. The ACP-103-033 result tables are all based on the safety analysis set (n=78).
Arm/Group Title All Patients
Hide Arm/Group Description All patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 2 visit, the dose could be increased to 34 mg QD based on the investigator’s assessment of clinical response. Subsequently, the dose could be adjusted from 34 mg to 20 mg or from 20 mg to 34 mg at any visit based on clinical response.
Period Title: Overall Study
Started 78
Completed 49
Not Completed 29
Reason Not Completed
Adverse Event             7
Death             3
Lack of Efficacy             4
Non-compliance with study drug             1
Protocol Violation             2
Withdrawal by Subject             3
Withdrawal by caregiver             3
Change in patient's living situation             4
Lost to Follow-up             2
Arm/Group Title All Patients
Hide Arm/Group Description All patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 2 visit, the dose could be increased to 34 mg QD based on the investigator’s assessment of clinical response. Subsequently, the dose could be adjusted from 34 mg to 20 mg or from 20 mg to 34 mg at any visit based on clinical response.
Overall Number of Baseline Participants 78
Hide Baseline Analysis Population Description
Treated patients (i.e. patients receiving at least 1 dose of open-label study drug)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 78 participants
76.9  (7.79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants
Female
37
  47.4%
Male
41
  52.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   2.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
69
  88.5%
More than one race
0
   0.0%
Unknown or Not Reported
7
   9.0%
Duration of symptoms of Alzheimer's disease  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 78 participants
6.2  (2.32)
1.Primary Outcome
Title Treatment Emergent Adverse Events (TEAEs)
Hide Description Safety and tolerability of pimavanserin after 52 weeks of treatment in patients with probable Alzheimer's disease who have symptoms of agitation and Aggression, in terms of occurrence of TEAEs
Time Frame 52 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Treated patients (i.e. patients receiving at least 1 dose of open-label study drug)
Arm/Group Title All Patients
Hide Arm/Group Description:
All patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 2 visit, the dose could be increased to 34 mg QD based on the investigator’s assessment of clinical response. Subsequently, the dose could be adjusted from 34 mg to 20 mg or from 20 mg to 34 mg at any visit based on clinical response.
Overall Number of Participants Analyzed 78
Measure Type: Count of Participants
Unit of Measure: Participants
53
  67.9%
Time Frame 52 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Patients
Hide Arm/Group Description All patients started treatment with pimavanserin 20 mg once daily (QD). At the Week 2 visit, the dose could be increased to 34 mg QD based on the investigator’s assessment of clinical response. Subsequently, the dose could be adjusted from 34 mg to 20 mg or from 20 mg to 34 mg at any visit based on clinical response.
All-Cause Mortality
All Patients
Affected / at Risk (%)
Total   3/78 (3.85%)    
Hide Serious Adverse Events
All Patients
Affected / at Risk (%) # Events
Total   12/78 (15.38%)    
Cardiac disorders   
Myocardial infarction * 1  1/78 (1.28%)  1
Gastrointestinal disorders   
Dyspepsia * 1  1/78 (1.28%)  1
Hepatobiliary disorders   
Cholecystitis acute * 1  1/78 (1.28%)  1
Infections and infestations   
Diverticulitis * 1  1/78 (1.28%)  1
Escherichia bacteraemia * 1  1/78 (1.28%)  1
Pneumonia * 1  2/78 (2.56%)  2
Injury, poisoning and procedural complications   
Pelvic fracture * 1  1/78 (1.28%)  1
Musculoskeletal and connective tissue disorders   
Spondylolisthesis * 1  1/78 (1.28%)  1
Nervous system disorders   
Cerebral haemorrhage * 1  1/78 (1.28%)  1
Syncope * 1  2/78 (2.56%)  2
Dementia Alzheimer's type * 1  1/78 (1.28%)  1
Dizziness * 1  1/78 (1.28%)  1
Renal and urinary disorders   
Renal failure * 1  1/78 (1.28%)  1
Respiratory, thoracic and mediastinal disorders   
Respiratory failure * 1  1/78 (1.28%)  1
1
Term from vocabulary, MedDRA (19.0)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Patients
Affected / at Risk (%) # Events
Total   20/78 (25.64%)    
Infections and infestations   
Urinary tract infection * 1  6/78 (7.69%)  9
Upper respiratory tract infection * 1  5/78 (6.41%)  6
Injury, poisoning and procedural complications   
Fall * 1  7/78 (8.97%)  7
Investigations   
Weight decreased * 1  4/78 (5.13%)  4
Psychiatric disorders   
Agitation * 1  5/78 (6.41%)  8
1
Term from vocabulary, MedDRA (19.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
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.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sr. Dir. Medical Information and Medical Communications
Organization: ACADIA Pharmaceuticals Inc.
Phone: 858-261-2897
EMail: medicalinformation@acadia-pharm.com
Layout table for additonal information
Responsible Party: ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03118947    
Other Study ID Numbers: ACP-103-033
2016-001128-78 ( EudraCT Number )
First Submitted: April 12, 2017
First Posted: April 18, 2017
Results First Submitted: February 25, 2020
Results First Posted: March 9, 2020
Last Update Posted: April 9, 2020