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

A 52-Week Open-Label Extension Study of Pimavanserin for the Treatment of Agitation and Aggression in Subjects With Alzheimer's Disease

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

Study Overview

• Status: Completed
• Conditions: Agitation and Aggression in Alzheimer's Disease
• Intervention / Treatment: Drug: Pimavanserin

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Phase 2

Contacts and Locations

Study Locations

• Chile
  • Antofagasta, Chile, 127-0244
    • Psicomed Estudios Médicos
  • Santiago, Chile, 7500710
    • BioMedica Research Group
  • Santiago, Chile, 7560356
    • Especialidades Medicas L Y S
• France
  • Cedex 9
    • Toulouse, Cedex 9, France, 31059
      • CHU de Toulouse - Cite de la sante - Gerontople
• Spain
  • Elche, Spain, 03203
    • Hospital General Universitario de Elche
  • Terrassa, Spain, 08221
    • Hospital Universitari Mutua de Terrassa
  • Zaragoza, Spain, 50012
    • Hospital Viamed Montecanal
  • Viscaya
    • Algorta, Viscaya, Spain, 48993
      • Centro de Atencion Especializada Oroitu
• United Kingdom
  • Bath, United Kingdom, BA1 3NG
    • RICE-The Research Institute for the Care of Older People, The RICE Centre, The Royal United Hospital
  • Isleworth, United Kingdom, TW7 6AF
    • West London Cognitive Disorders Treatment & Research Unit, Lakeside Mental Health Unit, West Middlesex University Hosp. Site
  • Manchester, United Kingdom, M8 5RB
    • Greater Manchester Mental Health NHS Foundation Trust
• United States
  • California
    • Costa Mesa, California, United States, 92626
      • ATP Clinical Research, Inc.
    • Fresno, California, United States, 93710
      • Neuro-Pain Medical Center
    • Fullerton, California, United States, 92835
      • Neurology Center of North Orange County
    • San Diego, California, United States, 92103
      • Pacific Clinical Research Network
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Clinical Research Unit
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Parkinson's Disease and Movement Disorders Center of Boca Raton
    • Deerfield Beach, Florida, United States, 33064
      • Quantum Laboratories Inc.
    • Miami, Florida, United States, 33137
      • Miami Jewish Health Systems
    • Naples, Florida, United States, 34105
      • Collier Neurologic Specialists LLC
  • Maine
    • Bangor, Maine, United States, 04401
      • Acadia Hospital
  • Massachusetts
    • Quincy, Massachusetts, United States, 02169
      • Alzheimer's Disease Center
  • New Jersey
    • Eatontown, New Jersey, United States, 07724
      • Memory Enhancement Center of America, Inc.
    • Toms River, New Jersey, United States, 08755
      • Bio Behavioral Health
  • North Carolina
    • Charlotte, North Carolina, United States, 28270
      • ANI Neurology, PLLC dba Alzheimer's Memory Center
  • Pennsylvania
    • Willow Grove, Pennsylvania, United States, 19090
      • Abington Neurological Associates, Ltd.
  • Texas
    • DeSoto, Texas, United States, 75115
      • InSite Clinical Research, LLC
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Pharmaceutical Research Associates, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Must complete the Week 12 visit in Study ACP-103-032 while continuing to take his/her assigned dose of blinded study drug

2. 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.
3. Lives at home or in an assisted living or care facility (but has the capacity to visit the clinic as an outpatient)
4. Has a designated study partner/caregiver who is in contact with the patient at least 3 times a week on 3 separate days
5. 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
6. The patient and caregiver are willing and able to participate in all schedule evaluations and complete all required tests

Exclusion Criteria:

1. Patient was significantly non-compliant in Study ACP-103-032
2. 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
3. Patient or study partner/caregiver has a medical condition (e.g., hearing, vision impairments) that would impair the ability to perform the study assessments.
4. 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
5. Has clinically significant laboratory abnormalities that would jeopardize the safe participation of the patient in the study
6. Has a Global Clinician Assessment of Suicidality (GCAS) score of 3 or 4 based on Investigator's assessment of behavior since the last assessment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pimavanserin 20 mg OR 34 mg per day	Drug: Pimavanserin; Pimavanserin 20 mg, tablet, taken as two 10 mg tablets, once daily by mouth, OR Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Emergent Adverse Events (TEAEs)	Safety and tolerability of pimavanserin after 52 weeks of treatment in patients with probable Alzheimer's disease who have symptoms of agitation and Aggression, in terms of occurrence of TEAEs	52 weeks

Collaborators and Investigators

• Sponsor: ACADIA Pharmaceuticals Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 23, 2017
• Primary Completion (ACTUAL): February 25, 2019
• Study Completion (ACTUAL): February 25, 2019

Study Registration Dates

• First Submitted: April 12, 2017
• First Submitted That Met QC Criteria: April 17, 2017
• First Posted (ACTUAL): April 18, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 9, 2020
• Last Update Submitted That Met QC Criteria: April 2, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Neurodegenerative Diseases; Dyskinesias; Psychomotor Disorders; Dementia; Tauopathies; Aggression; Psychomotor Agitation; Alzheimer Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Antiparkinson Agents; Anti-Dyskinesia Agents; Pimavanserin
• Other Study ID Numbers: ACP-103-033; 2016-001128-78 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No