A Study of Pimavanserin for the Treatment of Agitation and Aggression in Subjects With Alzheimer's Disease

Completed · Phase 2

Conditions studied: Agitation and Aggression in Alzheimer's Disease

In brief

To evaluate the safety and tolerability of pimavanserin over 52 weeks of treatment in subjects with probable AD who have symptoms of agitation and aggression

Key facts

Study ID

NCT03118947

Run by

ACADIA Pharmaceuticals Inc.

People needed

79

Starts

2017-02-23

Expected to finish

2019-02-25

Last updated by the study team

2020-04-09

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must complete the Week 12 visit in Study ACP-103-032 while continuing to take his/her assigned dose of blinded study drug
• Can understand the nature of the trial and protocol requirements and provide signed informed consent
• from patient, if deemed competent to provide consent
• from an appropriate person (e.g. patient's Legally Authorized Representative (LAR) with the patient's assent) if patient is deemed not competent to provide informed consent.
• Lives at home or in an assisted living or care facility (but has the capacity to visit the clinic as an outpatient)
• Has a designated study partner/caregiver who is in contact with the patient at least 3 times a week on 3 separate days
• Female patients must be of non-childbearing potential or must agree to use an acceptable method of contraception or abstinence, during the study, and 1 month following completion of the study
• The patient and caregiver are willing and able to participate in all schedule evaluations and complete all required tests

You may not qualify if…

• Patient was significantly non-compliant in Study ACP-103-032
• The Investigator becomes aware of an impending and unexpected change in the patient's living situation (e.g., change in caregiver, change in facility, moving from home to facility, moving from one family member or caregiver's home to another) that may cause a major disruption in the patient's behavior
• Patient or study partner/caregiver has a medical condition (e.g., hearing, vision impairments) that would impair the ability to perform the study assessments.
• Patient is bedridden or has any significant medical condition that is unstable and would place the patient at undue risk from study drug or study procedures
• Has clinically significant laboratory abnormalities that would jeopardize the safe participation of the patient in the study
• Has a Global Clinician Assessment of Suicidality (GCAS) score of 3 or 4 based on Investigator's assessment of behavior since the last assessment

Where it is running

• ATP Clinical Research, Inc. — Costa Mesa, California, United States
• Neuro-Pain Medical Center — Fresno, California, United States
• Neurology Center of North Orange County — Fullerton, California, United States
• Pacific Clinical Research Network — San Diego, California, United States
• Clinical Research Unit — Washington D.C., District of Columbia, United States
• Parkinson's Disease and Movement Disorders Center of Boca Raton — Boca Raton, Florida, United States
• Quantum Laboratories Inc. — Deerfield Beach, Florida, United States
• Miami Jewish Health Systems — Miami, Florida, United States
• Collier Neurologic Specialists LLC — Naples, Florida, United States
• Acadia Hospital — Bangor, Maine, United States
• Alzheimer's Disease Center — Quincy, Massachusetts, United States
• Memory Enhancement Center of America, Inc. — Eatontown, New Jersey, United States
• Bio Behavioral Health — Toms River, New Jersey, United States
• ANI Neurology, PLLC dba Alzheimer's Memory Center — Charlotte, North Carolina, United States
• Abington Neurological Associates, Ltd. — Willow Grove, Pennsylvania, United States
• Insite Clinical Research, LLC — DeSoto, Texas, United States
• Pharmaceutical Research Associates, Inc. — Salt Lake City, Utah, United States
• Psicomed Estudios Médicos — Antofagasta, Chile
• Biomedica Research Group — Santiago, Chile
• Especialidades Medicas L y S — Santiago, Chile
• CHU de Toulouse - Cite de la sante - Gerontople — Toulouse, Cedex 9, France
• Centro de Atencion Especializada Oroitu — Algorta, Viscaya, Spain
• Hospital General Universitario de Elche — Elche, Spain
• Hospital Universitari Mutua de Terrassa — Terrassa, Spain
• Hospital Viamed Montecanal — Zaragoza, Spain

Full record on ClinicalTrials.gov

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