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Pimavanserin for Agitation and Aggression in Alzheimer's Disease


This Phase II, 12-week study will test the drug pimavanserin (Nuplazid™) as a treatment for agitation and aggression in adults with Alzheimer's disease. 

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years N/A Both No
November 2016
June 2019

  • Diagnosis of probable Alzheimer's disease
  • Agitation as defined by International Psychogeriatric Association guidelines
  • Ability to visit clinic as an outpatient
  • Living at current location for at least 3 weeks and plan to remain there for duration of trial
  • Designated study partner/caregiver who is in contact with participant at least three times a week
  • Women must be non-childbearing or agree to use contraception or be abstinent

  • Agitation/aggression attributable to medications, environmental conditions, substance abuse, or active medical or psychiatric condition
  • Treatment with an antipsychotic medication within 2 weeks of baseline visit or 5 half lives, whichever is longer
  • Participant or study partner/caregiver with medical condition that would impair the ability to perform assessments
  • Heart attack within the last 6 months
  • History or symptoms of long QT syndrome
  • History of significant psychotic disorder, including schizophrenia or bipolar disorder
  • Sensitivity to pimavanserin 
  • Previous participation in clinical study with pimavanserin

Pimavanserin is an FDA-approved drug to treat hallucinations and delusions in people with psychosis from Parkinson's disease. It is an antipsychotic that changes the activity of certain natural substances in the brain. In this trial, participants will be randomly assigned to take the study drug or a placebo as a tablet once per day. Two different doses will be tested to gauge their effect on agitation.

For more information about this trial, contact J. Patrick Kesslak at 858-320-8699 or

Name City State Zip Status Primary Contact

Costa Mesa California 92626

Fresno California 93710

Fullerton California 92835

Los Angeles California 90073

Pasadena California 91105

San Diego California 92103

Danbury Connecticut 06810

Washington District of Columbia 20057

Boca Raton Florida 33486

Deerfield Beach Florida 33064

Miami Florida 33137

Naples Florida 34102

Atlanta Georgia 30322

Bangor Maine 04401

Quincy Massachusetts 02169

Clinton Township Michigan 48035

Flowood Mississippi 39232

Jackson Mississippi 39216

Eatontown New Jersey 07724

Marlton New Jersey 08053

Toms River New Jersey 08755

Albuquerque New Mexico 87131

Charlotte North Carolina 28270

Oklahoma City Oklahoma 73112

Medford Oregon 97504

Jenkintown Pennsylvania 19046

Norristown Pennsylvania 19401

Willow Grove Pennsylvania 19090

Charleston South Carolina 29401

Nashville Tennessee 37212

DeSoto Texas 75115

Salt Lake City Utah 84107

Spokane Washington 99202

ACADIA Pharmaceuticals Inc.

Name Phone Email
James M. Youakim, MD 858-261-2981
J. Patrick Kesslak 858-320-8699


A Double-Blind, Placebo-Controlled Study to Examine the Safety and Efficacy of Pimavanserin for the Treatment of Agitation and Aggression in Alzheimer's Disease