Skip to main content

Pimavanserin for Agitation and Aggression in Alzheimer's Disease

Completed

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
432

  • 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 pkesslak@acadia-pharm.com.

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 jyouakim@acadia-pharm.com
J. Patrick Kesslak 858-320-8699 pkesslak@acadia-pharm.com

NCT02992132

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