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
2 other identifiers
interventional
79
5 countries
28
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2017
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 23, 2017
CompletedFirst Submitted
Initial submission to the registry
April 12, 2017
CompletedFirst Posted
Study publicly available on registry
April 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 25, 2019
CompletedResults Posted
Study results publicly available
March 9, 2020
CompletedApril 9, 2020
April 1, 2020
2 years
April 12, 2017
February 25, 2020
April 2, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Pimavanserin 20 mg OR 34 mg per day
EXPERIMENTALInterventions
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
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
ATP Clinical Research, Inc.
Costa Mesa, California, 92626, United States
Neuro-Pain Medical Center
Fresno, California, 93710, United States
Neurology Center of North Orange County
Fullerton, California, 92835, United States
Pacific Clinical Research Network
San Diego, California, 92103, United States
Clinical Research Unit
Washington D.C., District of Columbia, 20007, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486, United States
Quantum Laboratories Inc.
Deerfield Beach, Florida, 33064, United States
Miami Jewish Health Systems
Miami, Florida, 33137, United States
Collier Neurologic Specialists LLC
Naples, Florida, 34105, United States
Acadia Hospital
Bangor, Maine, 04401, United States
Alzheimer's Disease Center
Quincy, Massachusetts, 02169, United States
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, 07724, United States
Bio Behavioral Health
Toms River, New Jersey, 08755, United States
ANI Neurology, PLLC dba Alzheimer's Memory Center
Charlotte, North Carolina, 28270, United States
Abington Neurological Associates, Ltd.
Willow Grove, Pennsylvania, 19090, United States
Insite Clinical Research, LLC
DeSoto, Texas, 75115, United States
Pharmaceutical Research Associates, Inc.
Salt Lake City, Utah, 84107, United States
Psicomed Estudios Médicos
Antofagasta, 127-0244, Chile
Biomedica Research Group
Santiago, 7500710, Chile
Especialidades Medicas L y S
Santiago, 7560356, Chile
CHU de Toulouse - Cite de la sante - Gerontople
Toulouse, Cedex 9, 31059, France
Centro de Atencion Especializada Oroitu
Algorta, Viscaya, 48993, Spain
Hospital General Universitario de Elche
Elche, 03203, Spain
Hospital Universitari Mutua de Terrassa
Terrassa, 08221, Spain
Hospital Viamed Montecanal
Zaragoza, 50012, Spain
RICE-The Research Institute for the Care of Older People, The RICE Centre, The Royal United Hospital
Bath, BA1 3NG, United Kingdom
West London Cognitive Disorders Treatment & Research Unit, Lakeside Mental Health Unit, West Middlesex University Hosp. Site
Isleworth, TW7 6AF, United Kingdom
Greater Manchester Mental Health NHS Foundation Trust
Manchester, M8 5RB, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. Dir. Medical Information and Medical Communications
- Organization
- ACADIA Pharmaceuticals Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2017
First Posted
April 18, 2017
Study Start
February 23, 2017
Primary Completion
February 25, 2019
Study Completion
February 25, 2019
Last Updated
April 9, 2020
Results First Posted
March 9, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share