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

NCT ID: NCT03118947

Last Updated: 2020-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-23
• Study Completion Date: 2019-02-25

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

Conditions

Agitation and Aggression in Alzheimer's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pimavanserin 20 mg OR 34 mg per day

Group Type: EXPERIMENTAL

Pimavanserin

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ACADIA Pharmaceuticals Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ATP Clinical Research, Inc.

Costa Mesa, California, United States

Neuro-Pain Medical Center

Fresno, California, United States

Neurology Center of North Orange County

Fullerton, California, United States

Pacific Clinical Research Network

San Diego, California, United States

Clinical Research Unit

Washington D.C., District of Columbia, United States

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, United States

Quantum Laboratories Inc.

Deerfield Beach, Florida, United States

Miami Jewish Health Systems

Miami, Florida, United States

Collier Neurologic Specialists LLC

Naples, Florida, United States

Acadia Hospital

Bangor, Maine, United States

Alzheimer's Disease Center

Quincy, Massachusetts, United States

Memory Enhancement Center of America, Inc.

Eatontown, New Jersey, United States

Bio Behavioral Health

Toms River, New Jersey, United States

ANI Neurology, PLLC dba Alzheimer's Memory Center

Charlotte, North Carolina, United States

Abington Neurological Associates, Ltd.

Willow Grove, Pennsylvania, United States

Insite Clinical Research, LLC

DeSoto, Texas, United States

Pharmaceutical Research Associates, Inc.

Salt Lake City, Utah, United States

Psicomed Estudios Médicos

Antofagasta, , Chile

Biomedica Research Group

Santiago, , Chile

Especialidades Medicas L y S

Santiago, , Chile

CHU de Toulouse - Cite de la sante - Gerontople

Toulouse, Cedex 9, France

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, , 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

Greater Manchester Mental Health NHS Foundation Trust

Manchester, , United Kingdom

Countries

United States; Chile; France; Spain; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016-001128-78

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ACP-103-033

Identifier Type: -

Identifier Source: org_study_id