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

Recruiting in Palo Alto (17 mi)

+107 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: ACADIA Pharmaceuticals Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the long-term safety and tolerability of pimavanserin in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease exposed to open-label pimavanserin for up to 52 weeks.

Research Team

Eligibility Criteria

Inclusion Criteria

The investigator believes that the subject is in contact with them frequently enough to accurately report on the subject's symptoms and whether or not the subject is taking the study drug.

Is fluent in the local language in which study assessments will be administered

Agrees to participate in study assessments, has the capacity to provide informed consent, and provides written consent to participate in the study

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Exclusion Criteria

If the subject is not on citalopram, escitalopram, or venlafaxine:

QTcF >450 ms, if QRS duration <120 ms

QTcF >470 ms, if QRS duration ≥120 ms

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Treatment Details

Interventions

Pimavanserin (Serotonin Inverse Agonist/Antagonist)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Drug - pimavanserinExperimental Treatment1 Intervention

Pimavanserin 34 mg is provided as 2×17 mg tablets as single dose, once daily by mouth. Dose adjustments of pimavanserin down to 20 mg (provided as 2×10 mg tablets as a single dose, once daily by mouth) and up to 34 mg are permitted based on Investigator assessment of clinical response.