Back to resultsA Study of Pimavanserin for the Treatment of Agitation and Aggression in Subjects With Alzheimer's Disease
Primary Purpose
Agitation and Aggression in Alzheimer's Disease
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Pimavanserin
Sponsored by
About this trial
This is an interventional treatment trial for Agitation and Aggression in Alzheimer's Disease
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- ATP Clinical Research, Inc.
- Neuro-Pain Medical Center
- Neurology Center of North Orange County
- Pacific Clinical Research Network
- Clinical Research Unit
- Parkinson's Disease and Movement Disorders Center of Boca Raton
- Quantum Laboratories Inc.
- Miami Jewish Health Systems
- Collier Neurologic Specialists LLC
- Acadia Hospital
- Alzheimer's Disease Center
- Memory Enhancement Center of America, Inc.
- Bio Behavioral Health
- ANI Neurology, PLLC dba Alzheimer's Memory Center
- Abington Neurological Associates, Ltd.
- Insite Clinical Research, LLC
- Pharmaceutical Research Associates, Inc.
- Psicomed Estudios Médicos
- Biomedica Research Group
- Especialidades Medicas L y S
- CHU de Toulouse - Cite de la sante - Gerontople
- Centro de Atencion Especializada Oroitu
- Hospital General Universitario de Elche
- Hospital Universitari Mutua de Terrassa
- Hospital Viamed Montecanal
- RICE-The Research Institute for the Care of Older People, The RICE Centre, The Royal United Hospital
- West London Cognitive Disorders Treatment & Research Unit, Lakeside Mental Health Unit, West Middlesex University Hosp. Site
- Greater Manchester Mental Health NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pimavanserin 20 mg OR 34 mg per day
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03118947
First Posted
April 12, 2017
Last Updated
April 2, 2020
Sponsor
ACADIA Pharmaceuticals Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03118947
Brief Title
A Study of Pimavanserin for the Treatment of Agitation and Aggression in Subjects With Alzheimer's Disease
Official Title
A 52-Week Open-Label Extension Study of Pimavanserin for the Treatment of Agitation and Aggression in Subjects With Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 23, 2017 (Actual)
Primary Completion Date
February 25, 2019 (Actual)
Study Completion Date
February 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ACADIA Pharmaceuticals Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation and Aggression in Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pimavanserin 20 mg OR 34 mg per day
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Pimavanserin
Intervention Description
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 Measure Information:
Title
Treatment Emergent Adverse Events (TEAEs)
Description
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
Time Frame
52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
ATP Clinical Research, Inc.
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Neuro-Pain Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Facility Name
Neurology Center of North Orange County
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Pacific Clinical Research Network
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Clinical Research Unit
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Parkinson's Disease and Movement Disorders Center of Boca Raton
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Quantum Laboratories Inc.
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Miami Jewish Health Systems
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Collier Neurologic Specialists LLC
City
Naples
State/Province
Florida
ZIP/Postal Code
34105
Country
United States
Facility Name
Acadia Hospital
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Alzheimer's Disease Center
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
Facility Name
Memory Enhancement Center of America, Inc.
City
Eatontown
State/Province
New Jersey
ZIP/Postal Code
07724
Country
United States
Facility Name
Bio Behavioral Health
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
ANI Neurology, PLLC dba Alzheimer's Memory Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28270
Country
United States
Facility Name
Abington Neurological Associates, Ltd.
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
Insite Clinical Research, LLC
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Pharmaceutical Research Associates, Inc.
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Psicomed Estudios Médicos
City
Antofagasta
ZIP/Postal Code
127-0244
Country
Chile
Facility Name
Biomedica Research Group
City
Santiago
ZIP/Postal Code
7500710
Country
Chile
Facility Name
Especialidades Medicas L y S
City
Santiago
ZIP/Postal Code
7560356
Country
Chile
Facility Name
CHU de Toulouse - Cite de la sante - Gerontople
City
Toulouse
State/Province
Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
Centro de Atencion Especializada Oroitu
City
Algorta
State/Province
Viscaya
ZIP/Postal Code
48993
Country
Spain
Facility Name
Hospital General Universitario de Elche
City
Elche
ZIP/Postal Code
03203
Country
Spain
Facility Name
Hospital Universitari Mutua de Terrassa
City
Terrassa
ZIP/Postal Code
08221
Country
Spain
Facility Name
Hospital Viamed Montecanal
City
Zaragoza
ZIP/Postal Code
50012
Country
Spain
Facility Name
RICE-The Research Institute for the Care of Older People, The RICE Centre, The Royal United Hospital
City
Bath
ZIP/Postal Code
BA1 3NG
Country
United Kingdom
Facility Name
West London Cognitive Disorders Treatment & Research Unit, Lakeside Mental Health Unit, West Middlesex University Hosp. Site
City
Isleworth
ZIP/Postal Code
TW7 6AF
Country
United Kingdom
Facility Name
Greater Manchester Mental Health NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Pimavanserin for the Treatment of Agitation and Aggression in Subjects With Alzheimer's Disease
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