A Study of Pimavanserin for the Treatment of Agitation and Aggression in Subjects With Alzheimer's Disease
Status: | Active, not recruiting |
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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 |
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
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
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