A Study of the Safety and Efficacy of Pimavanserin in Patients With Alzheimer's Disease Psychosis

Study Overview
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Brief Summary
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This study will evaluate the safety and efficacy of pimavanserin 40 mg compared to placebo in patients with Alzheimer's disease psychosis.

Official Title
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A Single Center, Double-Blind, Placebo-Controlled Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Psychosis in Alzheimer's Disease

Conditions
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Alzheimer's Disease Psychosis

Intervention / Treatment
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* Drug: Pimavanserin tartrate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must be 50 years of age or older with NINCDS-ADRDA defined possible or probable AD Patient must have psychotic symptoms that developed after the diagnosis of AD was established. These symptoms must include visual and/or auditory hallucinations, and/or delusions Patient must have been a nursing home resident for ≥ 4 weeks prior to randomization, not bedridden and expected to remain in the facility throughout the study Patient must have actively experienced and verbally communicated psychotic symptoms during the month prior to the Screening visit and weekly during the previous 2 weeks prior to Baseline If patient is on acetylcholinesterase inhibitor (AChEI) therapy and/or memantine, must be on stable doses for 3 months prior to the Baseline visit and during the study Patient is willing and able to provide informed consent. If the subject is unable to provide written consent due to the severity of dementia, consent must be given by a legally authorized representative Exclusion Criteria: Patient has a history of significant psychotic disorders prior to or concomitantly with the diagnosis of Alzheimer's disease including, but not limited to, schizophrenia or bipolar disorder Patient is unable to communicate verbally Patient has current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, renal, hematologic or other medical disorder, including cancer or malignancies, which would affect the patient's ability to participate in the study Patient has had a myocardial infarction in the last six months Patient has moderate to severe congestive heart failure Patient has any surgery planned during the screening, treatment, or follow-up periods that could interfere with participation in the study per the protocol assessments Patients will be evaluated at screening to ensure that all criteria for study participation are met. These evaluations will include specific measures of psychosis severity, delirium, dementia, cardiovascular condition, and pregnancy status. Patients may be excluded from the study based on these assessments (and specifically if it is determined that their baseline health and psychiatric condition do not meet all protocol-specified entry criteria).

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo, two tablets, once daily by mouth | Drug: Placebo<br>* Placebo, two tablets, once daily by mouth<br>|
| Experimental: Pimavanserin 40 mg<br>Pimavanserin tartrate, 40 mg (two 20 mg tablets), once daily by mouth (equivalent to 34 mg free base pimavanserin) | Drug: Pimavanserin tartrate<br>* Pimavanserin tartrate, 40 mg (two 20 mg tablets), once daily by mouth (equivalent to 34 mg free base pimavanserin)<br>* Other names: ACP-103;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antipsychotic Efficacy | Change from Baseline to Day 43 in the Neuropsychiatric Inventory-Nursing Home Version (NPI-NH) psychosis score (Delusions [Domain A]+Hallucinations [Domain B]) in the Full Analysis Set (FAS). The NPI-NH is a questionnaire that quantifies behavioral changes in dementia in nursing home patients and evaluates 12 behavioral domains. For each of the 12 behavioral domains the Frequency (scale:1=occasionally to 4=very frequently) is multiplied by the Severity (scale:1=Mild to 3=Severe) to obtain a domain score (frequency x severity), The NPI-NH Psychosis Subscale consists of the two domains of Delusions and Hallucinations, calculated by adding the Individual domain scores, to yield a possible total score of 0 to 24. Lower scores correspond to less severity. A negative change score from baseline indicates improvement. | Day 43 |