Extension Study of Pimavanserin in Adult Subjects With Neuropsychiatric Symptoms Related to Neurodegenerative Disease

Exclusion Criteria

• •1. Subject is judged by the Investigator or the Medical Monitor to be inappropriate for the study, due to AEs, medical condition, or noncompliance with investigational product or study procedures in the antecedent study, or is judged to be a danger to self or others
• •2. Is in hospice, is receiving end-of-life palliative care, or has become bedridden
• •3. Has any of the following ECG results at the EOT/ET visit of the antecedent study:
• •a. If the subject is not on citalopram, escitalopram, or venlafaxine:
• •i. QTcF \>450 ms, if QRS duration \<120 ms
• •ii. QTcF \>470 ms, if QRS duration ≥120 ms
• •b. If the subject is on citalopram, escitalopram, or venlafaxine:
• •i. QTcF \>425 ms, if QRS duration \<120 ms
• •ii. QTcF \>450 ms, if QRS duration ≥120 ms
• •4. Has a heart rate \<50 beats per minute. If bradycardia is secondary to iatrogenic or treatable causes and these causes are treated, a heart rate assessment can be repeated at the EOT/ET visit of the antecedent study.
• •5. Has clinically significant laboratory abnormalities in the antecedent study that, in the judgment of the Investigator or Medical Monitor, would either:
• •1. jeopardize the safe participation of the subject in the study; OR
• •2. would interfere with the conduct or interpretation of safety or efficacy evaluations in the study
• •6. Is suicidal at Visit 1 (Baseline)
• •7. Has developed a medical condition that in the judgment of the Investigator, would increase the risk associated with taking study medication or significantly interfere with the conduct or interpretation of the study
• •8. Requires treatment with a medication or other substance that is prohibited by the protocol
• •9. Has a significant sensitivity or allergic reaction to pimavanserin or its excipients
• •10. Is an employee of ACADIA, or has a family member who is an employee of ACADIA
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