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

Agitation and Aggression in Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03118947
• Other study ID #: ACP-103-033
• Secondary ID: 2016-001128-78
• Status: Completed
• Phase: Phase 2
• Start date: February 23, 2017
• Est. completion date: February 25, 2019

Study information

• Verified date: April 2020
• Source: ACADIA Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: February 25, 2019
• Est. primary completion date: February 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aggression
• Agitation and Aggression in Alzheimer's Disease
• Alzheimer Disease
• Psychomotor Agitation

Intervention

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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
ACADIA Pharmaceuticals Inc.

Countries where clinical trial is conducted

United States,  Chile,  France,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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