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

Study Overview
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Brief Summary
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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

Official Title
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A 52-Week Open-Label Extension Study of Pimavanserin for the Treatment of Agitation and Aggression in Subjects With Alzheimer's Disease

Conditions
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Agitation and Aggression in Alzheimer's Disease

Intervention / Treatment
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* Drug: Pimavanserin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must complete the Week 12 visit in Study ACP-103-032 while continuing to take his/her assigned dose of blinded study drug 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. Lives at home or in an assisted living or care facility (but has the capacity to visit the clinic as an outpatient) Has a designated study partner/caregiver who is in contact with the patient at least 3 times a week on 3 separate days 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 The patient and caregiver are willing and able to participate in all schedule evaluations and complete all required tests Exclusion Criteria: Patient was significantly non-compliant in Study ACP-103-032 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 Patient or study partner/caregiver has a medical condition (e.g., hearing, vision impairments) that would impair the ability to perform the study assessments. 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 Has clinically significant laboratory abnormalities that would jeopardize the safe participation of the patient in the study Has a Global Clinician Assessment of Suicidality (GCAS) score of 3 or 4 based on Investigator's assessment of behavior since the last assessment

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pimavanserin 20 mg OR 34 mg per day<br> | Drug: Pimavanserin<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 52 weeks |