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



Status:Active, not recruiting
Conditions:Alzheimer Disease, Neurology, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:50 - Any
Updated:10/26/2018
Start Date:February 23, 2017
End Date:August 2019

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

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


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
We found this trial at
18
sites
Quincy, Massachusetts 02169
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Quincy, MA
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736 E Bullard Ave
Fresno, California 93710
559-437-9700
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Fresno, CA
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Antofagasta, 12702
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Antofagasta,
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Bangor, Maine 04401
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Bangor, ME
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Boca Raton, FL
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Charlotte, North Carolina 28211
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Charlotte, NC
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Costa Mesa, California 92626
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Costa Mesa, CA
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Deerfield Beach, Florida 33064
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Deerfield Beach, FL
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DeSoto, Texas 75115
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DeSoto, TX
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Eatontown, New Jersey 07724
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Eatontown, NJ
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Fullerton, California 92835
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Fullerton, CA
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Miami, Florida 33137
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Miami, FL
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Naples, Florida 34102
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Naples, FL
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Salt Lake City, Utah 32751
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Salt Lake City, UT
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San Diego, California 92103
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San Diego, CA
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Toms River, New Jersey 08755
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Toms River, NJ
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Washington, District of Columbia 20007
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Washington,
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Willow Grove, Pennsylvania 19090
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Willow Grove, PA
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