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Trial record 2 of 4 for:    Pimavanserin | Alzheimer Disease

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

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ClinicalTrials.gov Identifier: NCT03118947
Recruitment Status : Active, not recruiting
First Posted : April 18, 2017
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
ACADIA Pharmaceuticals Inc.

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Agitation and Aggression in Alzheimer's Disease Drug: Pimavanserin Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 111 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 52-Week Open-Label Extension Study of Pimavanserin for the Treatment of Agitation and Aggression in Subjects With Alzheimer's Disease
Actual Study Start Date : February 23, 2017
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : August 2019


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




Primary Outcome Measures :
  1. Treatment emergent adverse events (TEAEs) [ Time Frame: Approximately 52 weeks ]
    Safety and tolerability of pimavanserin after 52 weeks of treatment in subjects with probable AD who have symptoms of agitation and aggression



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118947


  Hide Study Locations
Locations
United States, California
ATP Clinical Research, Inc.
Costa Mesa, California, United States, 92626
Neuropain Medical Center
Fresno, California, United States, 93710
Neurology Center of North Orange County
Fullerton, California, United States, 92835
SC3 Research Group
Pasadena, California, United States, 91105
Pacific Research Network
San Diego, California, United States, 92103
United States, Connecticut
Associated Neurologists, PC
Danbury, Connecticut, United States, 06810
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Florida
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States, 33486
Quantum Laboratories Inc.
Deerfield Beach, Florida, United States, 33064
Miami Jewish Health Systems
Miami, Florida, United States, 33137
Collier Neurologic Specialists LLC
Naples, Florida, United States, 34102
United States, Georgia
Emory Brain Health Center
Atlanta, Georgia, United States, 30322
United States, Maine
Acadia Hospital
Bangor, Maine, United States, 04401
United States, Massachusetts
Alzheimer's Disease Center
Quincy, Massachusetts, United States, 02169
Alzheimers Disease Center
Winchester, Massachusetts, United States, 01890
United States, Michigan
Michigan Neurology Associates
Clinton Township, Michigan, United States, 48035
United States, Mississippi
Precise Research Centers
Flowood, Mississippi, United States, 39232
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, New Jersey
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, United States, 07724
Pharmaceutical Research Associates, Inc.
Marlton, New Jersey, United States, 08053
Bio Behavioral Health
Toms River, New Jersey, United States, 08755
United States, North Carolina
ANI Neurology, PLLC
Charlotte, North Carolina, United States, 28270
United States, Pennsylvania
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States, 19046
Abington Neurological Associates, Ltd.
Willow Grove, Pennsylvania, United States, 19090
United States, South Carolina
Roper St. Francis Healthcare
Charleston, South Carolina, United States, 29401
United States, Texas
Insite Clinical Research, LLC
DeSoto, Texas, United States, 75115
United States, Utah
PRA Health Sciences
Salt Lake City, Utah, United States, 84107
Chile
Psicomed Estudios Médicos Cía Ltda
Antofagasta, Chile, 127-0244
Biomedica Research Group
Santiago, Chile
Especialidades Medicas L Y S
Santiago, Chile
France
Centre de Recherche Clinique
Toulouse, Cedex 9, France, 31059
Spain
Hospital General Universitario de Elche
Elche, Alicante, Spain, 03203
Centro de Atencion Especializada Oroitu Servicio Neurologia
Algorta, Viscaya, Spain, 48993
Hospital Universitario Reina Sofia
Cordoba, Spain, 14011
Centro de especialidades de Carabanchel-Hospital
Madrid, Spain, 28044
Hospital Mutua de Terrassa
Terrassa, Spain, 08221
Hospital Viamed Montecanal
Zaragoza, Spain, 50012
United Kingdom
RICE-The Research Institute for the Care of Older People, Royal United Hospital
Bath, United Kingdom, BA1 3NG
West London Mental Health Trust
Isleworth, United Kingdom, TW7 6AF
Greater Manchester Mental Health NHS Foundation Trust
Manchester, United Kingdom, M8 5RB
Northamptonshire Healthcare NHS - Foundation Trust - Berrywood Hospital
Northampton, United Kingdom, NN5 6UD
Sponsors and Collaborators
ACADIA Pharmaceuticals Inc.

Responsible Party: ACADIA Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03118947     History of Changes
Other Study ID Numbers: ACP-103-033
2016-001128-78 ( EudraCT Number )
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Psychomotor Disorders
Pimavanserin
Psychomotor Agitation
Aggression
Dementia
Tauopathies
Dyskinesias
Neurologic Manifestations
Neurobehavioral Manifestations
Signs and Symptoms
Behavioral Symptoms
Antiparkinson Agents
Anti-Dyskinesia Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action