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CompletedPhase 2Results posted

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

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

Eudract number2016-001128-78
Org study IDACP-103-033
NCT IDNCT03118947

Timeline

Milestones

Study start2017-02-23actual
Study first posted2017-04-18actual
Primary completion2019-02-25actual
Study completion2019-02-25actual
Results first posted2020-03-09actual
Last update posted2020-04-09actual

Assets

Drug assets

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
SexAll
Healthy volunteersNot accepted

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

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 endpoints
Primary/protocol endpoint

Treatment Emergent Adverse Events (TEAEs)

Time frame:52 weeks

event count, event

Primary/registry result

Treatment Emergent Adverse Events (TEAEs)

Time frame:52 weeks

event count, event

Posted result

GroupValue (count_of_participants), ParticipantsReported bounds
All Patientsn=78 Participants53-

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableClinicalTrials.gov results section

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.