Agitation and Aggression in Alzheimer's Disease
Conditions
Brief summary
To evaluate the safety and tolerability of pimavanserin over 52 weeks of treatment in subjects with probable AD who have symptoms of agitation and aggression
Interventions
DRUGPimavanserin
Pimavanserin 20 mg, tablet, taken as two 10 mg tablets, once daily by mouth, OR Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth
Sponsors
ACADIA Pharmaceuticals Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Must complete the Week 12 visit in Study ACP-103-032 while continuing to take his/her assigned dose of blinded study drug 2. Can understand the nature of the trial and protocol requirements and provide signed informed consent * from patient, if deemed competent to provide consent * from an appropriate person (e.g. patient's Legally Authorized Representative (LAR) with the patient's assent) if patient is deemed not competent to provide informed consent. 3. Lives at home or in an assisted living or care facility (but has the capacity to visit the clinic as an outpatient) 4. Has a designated study partner/caregiver who is in contact with the patient at least 3 times a week on 3 separate days 5. Female patients must be of non-childbearing potential or must agree to use an acceptable method of contraception or abstinence, during the study, and 1 month following completion of the study 6. The patient and caregiver are willing and able to participate in all schedule evaluations and complete all required tests
Exclusion criteria
1. Patient was significantly non-compliant in Study ACP-103-032 2. The Investigator becomes aware of an impending and unexpected change in the patient's living situation (e.g., change in caregiver, change in facility, moving from home to facility, moving from one family member or caregiver's home to another) that may cause a major disruption in the patient's behavior 3. Patient or study partner/caregiver has a medical condition (e.g., hearing, vision impairments) that would impair the ability to perform the study assessments. 4. Patient is bedridden or has any significant medical condition that is unstable and would place the patient at undue risk from study drug or study procedures 5. Has clinically significant laboratory abnormalities that would jeopardize the safe participation of the patient in the study 6. Has a Global Clinician Assessment of Suicidality (GCAS) score of 3 or 4 based on Investigator's assessment of behavior since the last assessment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Emergent Adverse Events (TEAEs) | 52 weeks | 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 |
Countries
Chile, France, Spain, United Kingdom, United States
Participant flow
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 78 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 7 |
| Overall Study | Change in patient's living situation | 4 |
| Overall Study | Death | 3 |
| Overall Study | Lack of Efficacy | 4 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Non-compliance with study drug | 1 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Withdrawal by caregiver | 3 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | All Patients |
|---|---|
| Age, Continuous | 76.9 years STANDARD_DEVIATION 7.79 |
| Duration of symptoms of Alzheimer's disease | 6.2 years STANDARD_DEVIATION 2.32 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Race (NIH/OMB) White | 69 Participants |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 41 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 78 |
| other Total, other adverse events | 20 / 78 |
| serious Total, serious adverse events | 12 / 78 |
Outcome results
Primary
Treatment Emergent Adverse Events (TEAEs)
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
Population: Treated patients (i.e. patients receiving at least 1 dose of open-label study drug)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Patients | Treatment Emergent Adverse Events (TEAEs) | 53 Participants |