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

Phase 2

Completed

• Conditions: Agitation and Aggression in Alzheimer's Disease
• Interventions: Drug: Pimavanserin

• Registration Number: NCT03118947
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-23
• Study First Submitted: 2017-04-12
• Study First Submitted QC: 2017-04-17
• Study First Posted: 2017-04-18
• Primary Completion: 2019-02-25
• Study Completion: 2019-02-25
• Results First Submitted: 2020-02-25
• Results First Submitted QC: 2020-02-25
• Results First Posted: 2020-03-09
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-02
• Last Update Posted: 2020-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pimavanserin 20 mg OR 34 mg per day	Pimavanserin	-

Primary Outcome Measures

Name	Time	Method
Treatment Emergent Adverse Events (TEAEs)	52 weeks	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

Trial Locations

Locations (28)

Miami Jewish Health Systems; 🇺🇸 Miami, Florida, United States

Acadia Hospital; 🇺🇸 Bangor, Maine, United States

Especialidades Medicas L y S; 🇨🇱 Santiago, Chile

Pharmaceutical Research Associates, Inc.; 🇺🇸 Salt Lake City, Utah, United States

Insite Clinical Research, LLC; 🇺🇸 DeSoto, Texas, United States

Pacific Clinical Research Network; 🇺🇸 San Diego, California, United States

Clinical Research Unit; 🇺🇸 Washington, District of Columbia, United States

ATP Clinical Research, Inc.; 🇺🇸 Costa Mesa, California, United States

Neurology Center of North Orange County; 🇺🇸 Fullerton, California, United States

Neuro-Pain Medical Center; 🇺🇸 Fresno, California, United States

Quantum Laboratories Inc.; 🇺🇸 Deerfield Beach, Florida, United States

Abington Neurological Associates, Ltd.; 🇺🇸 Willow Grove, Pennsylvania, United States

Hospital General Universitario de Elche; 🇪🇸 Elche, Spain

Alzheimer's Disease Center; 🇺🇸 Quincy, Massachusetts, United States

Hospital Universitari Mutua de Terrassa; 🇪🇸 Terrassa, Spain

Centro de Atencion Especializada Oroitu; 🇪🇸 Algorta, Viscaya, Spain

Memory Enhancement Center of America, Inc.; 🇺🇸 Eatontown, New Jersey, United States

ANI Neurology, PLLC dba Alzheimer's Memory Center; 🇺🇸 Charlotte, North Carolina, United States

Psicomed Estudios Médicos; 🇨🇱 Antofagasta, Chile

Biomedica Research Group; 🇨🇱 Santiago, Chile

Hospital Viamed Montecanal; 🇪🇸 Zaragoza, Spain

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

Parkinson's Disease and Movement Disorders Center of Boca Raton; 🇺🇸 Boca Raton, Florida, United States

Collier Neurologic Specialists LLC; 🇺🇸 Naples, Florida, United States

Bio Behavioral Health; 🇺🇸 Toms River, New Jersey, United States

CHU de Toulouse - Cite de la sante - Gerontople; 🇫🇷 Toulouse, Cedex 9, France

Greater Manchester Mental Health NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom