Trial Outcomes & Findings for A Study of Pimavanserin for the Treatment of Agitation and Aggression in Subjects With Alzheimer's Disease (NCT NCT03118947)
NCT ID: NCT03118947
Last Updated: 2020-04-09
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
79 participants
Primary outcome timeframe
52 weeks
Results posted on
2020-04-09
Participant Flow
This open-label extension study included patients completing double-blind, randomised, placebo-controlled study ACP-103-032 (NCT02992132).
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).
Participant milestones
| Measure |
All Patients
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 Study
STARTED
|
78
|
|
Overall Study
COMPLETED
|
49
|
|
Overall Study
NOT COMPLETED
|
29
|
Reasons for withdrawal
| Measure |
All Patients
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 Study
Adverse Event
|
7
|
|
Overall Study
Death
|
3
|
|
Overall Study
Lack of Efficacy
|
4
|
|
Overall Study
Non-compliance with study drug
|
1
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Withdrawal by caregiver
|
3
|
|
Overall Study
Change in patient's living situation
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
A Study of Pimavanserin for the Treatment of Agitation and Aggression in Subjects With Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
All Patients
n=78 Participants
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.
|
|---|---|
|
Age, Continuous
|
76.9 years
STANDARD_DEVIATION 7.79 • n=93 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
69 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=93 Participants
|
|
Duration of symptoms of Alzheimer's disease
|
6.2 years
STANDARD_DEVIATION 2.32 • n=93 Participants
|
PRIMARY outcome
Timeframe: 52 weeksPopulation: Treated patients (i.e. patients receiving at least 1 dose of open-label study drug)
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
Outcome measures
| Measure |
All Patients
n=78 Participants
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.
|
|---|---|
|
Treatment Emergent Adverse Events (TEAEs)
|
53 Participants
|
Adverse Events
All Patients
Serious events: 12 serious events
Other events: 20 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
All Patients
n=78 participants at risk
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.
|
|---|---|
|
Nervous system disorders
Cerebral haemorrhage
|
1.3%
1/78 • Number of events 1 • 52 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
1.3%
1/78 • Number of events 1 • 52 weeks
|
|
Nervous system disorders
Syncope
|
2.6%
2/78 • Number of events 2 • 52 weeks
|
|
Nervous system disorders
Dementia Alzheimer's type
|
1.3%
1/78 • Number of events 1 • 52 weeks
|
|
Nervous system disorders
Dizziness
|
1.3%
1/78 • Number of events 1 • 52 weeks
|
|
Cardiac disorders
Myocardial infarction
|
1.3%
1/78 • Number of events 1 • 52 weeks
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.3%
1/78 • Number of events 1 • 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.3%
1/78 • Number of events 1 • 52 weeks
|
|
Infections and infestations
Diverticulitis
|
1.3%
1/78 • Number of events 1 • 52 weeks
|
|
Infections and infestations
Escherichia bacteraemia
|
1.3%
1/78 • Number of events 1 • 52 weeks
|
|
Infections and infestations
Pneumonia
|
2.6%
2/78 • Number of events 2 • 52 weeks
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
1.3%
1/78 • Number of events 1 • 52 weeks
|
|
Renal and urinary disorders
Renal failure
|
1.3%
1/78 • Number of events 1 • 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
1.3%
1/78 • Number of events 1 • 52 weeks
|
Other adverse events
| Measure |
All Patients
n=78 participants at risk
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.
|
|---|---|
|
Injury, poisoning and procedural complications
Fall
|
9.0%
7/78 • Number of events 7 • 52 weeks
|
|
Infections and infestations
Urinary tract infection
|
7.7%
6/78 • Number of events 9 • 52 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
6.4%
5/78 • Number of events 6 • 52 weeks
|
|
Psychiatric disorders
Agitation
|
6.4%
5/78 • Number of events 8 • 52 weeks
|
|
Investigations
Weight decreased
|
5.1%
4/78 • Number of events 4 • 52 weeks
|
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