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A Study of Pimavanserin for the Treatment of Agitation and Aggression in Subjects With Alzheimer's Disease
A 52-Week Open-Label Extension Study of Pimavanserin for the Treatment of Agitation and Aggression in Subjects With Alzheimer's Disease
Lead sponsor
Asset
Pimavanserin
Listed sites
28
Recruiting sites
-
Enrollment
79
actual
Study population
Alzheimer’s disease
Key I/E criterion
•Study partner/caregiver required
Primary endpoint
•Treatment Emergent Adverse Events (TEAEs)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
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
Endpoints (2)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Behavior / neuropsychiatric
2 endpointsTreatment Emergent Adverse Events (TEAEs)
Time frame:52 weeks
event count, event
Treatment Emergent Adverse Events (TEAEs)
Time frame:52 weeks
event count, event
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| All Patientsn=78 Participants | 53 | - |
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.