Clinical trial NCT03118947: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Agitation and Aggression in Alzheimer's Disease
Lead sponsor: ACADIA Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2017-04-18
Enrollment: 79
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Treatment Emergent Adverse Events (TEAEs)
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: ATP Clinical Research, Inc.
state: California
city: Fresno
country: United States
facility: Neuro-Pain Medical Center
state: California
city: Fullerton
country: United States
facility: Neurology Center of North Orange County
state: California
city: San Diego
country: United States
facility: Pacific Clinical Research Network
state: California
city: Washington
country: United States
facility: Clinical Research Unit
state: District of Columbia
city: Boca Raton
country: United States
facility: Parkinson's Disease and Movement Disorders Center of Boca Raton
state: Florida
city: Deerfield Beach
country: United States
facility: Quantum Laboratories Inc.
state: Florida
city: Miami
country: United States
facility: Miami Jewish Health Systems
state: Florida
city: Naples
country: United States
facility: Collier Neurologic Specialists LLC
state: Florida
city: Bangor
country: United States
facility: Acadia Hospital
state: Maine
city: Quincy
country: United States
facility: Alzheimer's Disease Center
state: Massachusetts
city: Eatontown
country: United States
facility: Memory Enhancement Center of America, Inc.
state: New Jersey
city: Toms River
country: United States
facility: Bio Behavioral Health
state: New Jersey
city: Charlotte
country: United States
facility: ANI Neurology, PLLC dba Alzheimer's Memory Center
state: North Carolina
city: Willow Grove
country: United States
facility: Abington Neurological Associates, Ltd.
state: Pennsylvania
city: DeSoto
country: United States
facility: Insite Clinical Research, LLC
state: Texas
city: Salt Lake City
country: United States
facility: Pharmaceutical Research Associates, Inc.
state: Utah
city: Antofagasta
country: Chile
facility: Psicomed Estudios Médicos
city: Santiago
country: Chile
facility: Biomedica Research Group
city: Santiago
country: Chile
facility: Especialidades Medicas L y S
city: Toulouse
country: France
facility: CHU de Toulouse - Cite de la sante - Gerontople
state: Cedex 9
city: Algorta
country: Spain
facility: Centro de Atencion Especializada Oroitu
state: Viscaya
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
city: Terrassa
country: Spain
facility: Hospital Universitari Mutua de Terrassa
city: Zaragoza
country: Spain
facility: Hospital Viamed Montecanal
city: Bath
country: United Kingdom
facility: RICE-The Research Institute for the Care of Older People, The RICE Centre, The Royal United Hospital
city: Isleworth
country: United Kingdom
facility: West London Cognitive Disorders Treatment & Research Unit, Lakeside Mental Health Unit, West Middlesex University Hosp. Site
city: Manchester
country: United Kingdom
facility: Greater Manchester Mental Health NHS Foundation Trust
Study officials:
References: