MedTrace Logo

Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer's Disease (SERENE)

NCT02992132 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 111

Last updated 2019-03-28

Study results available
· View outcomes & findings →

Summary

To evaluate the efficacy of pimavanserin compared with placebo in treatment of agitation and aggression after 12 weeks of treatment

Conditions

  • Agitation and Aggression in Alzheimer's Disease

Interventions

DRUG

Pimavanserin 34 mg

Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth

DRUG

Pimavanserin 20 mg

Pimavanserin 20 mg, tablet, taken as two 10 mg tablets, once daily by mouth

OTHER

Placebo

Placebo, taken as two tablets, once daily by mouth

Sponsors & Collaborators

  • ACADIA Pharmaceuticals Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2018-01-25
Completion
2018-02-16

Countries

  • United States
  • Chile
  • France
  • Spain
  • United Kingdom

Study Locations

More Related Trials

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 NCT02992132 on ClinicalTrials.gov