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A Safety Study of Pimavanserin in Adult and Elderly Subjects Experiencing Neuropsychiatric Symptoms Related to Neurodegenerative Disease

NCT03575052 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 784

Last updated 2024-12-31

Study results available
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Summary

The purpose of this study is to assess the safety and tolerability of pimavanserin compared to placebo in adult and elderly subjects with neuropsychiatric symptoms related to neurodegenerative disease.

Conditions

  • Neuropsychiatric Symptoms Related to Neurodegenerative Disease

Interventions

DRUG

Pimavanserin

Pimavanserin 34 mg total daily dose, tablets, once daily by mouth (provided as two 17 mg NUPLAZID® tablets)

DRUG

Placebo

Placebo, tablets, once daily by mouth (provided as two placebo tablets)

Sponsors & Collaborators

  • ACADIA Pharmaceuticals Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-21
Primary Completion
2022-05-06
Completion
2022-05-06
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Colombia
  • Czechia
  • Georgia
  • Mexico
  • Poland
  • Romania
  • Russia
  • Serbia
  • South Africa
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03575052 on ClinicalTrials.gov