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

Use our guide to learn which trials are right for you!

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
Washington, District of Columbia 20007
2279
mi
from 91732
Washington,
Click here to add this to my saved trials
736 E Bullard Ave
Fresno, California 93710
559-437-9700
214
mi
from 91732
Fresno, CA
Click here to add this to my saved trials
Antofagasta, 12702
?
mi
from 91732
Antofagasta,
Click here to add this to my saved trials
Bangor, Maine 04401
2685
mi
from 91732
Bangor, ME
Click here to add this to my saved trials
2311
mi
from 91732
Boca Raton, FL
Click here to add this to my saved trials
Charlotte, North Carolina 28211
2105
mi
from 91732
Charlotte, NC
Click here to add this to my saved trials
Costa Mesa, California 92626
28
mi
from 91732
Costa Mesa, CA
Click here to add this to my saved trials
Deerfield Beach, Florida 33064
2313
mi
from 91732
Deerfield Beach, FL
Click here to add this to my saved trials
DeSoto, Texas 75115
1223
mi
from 91732
DeSoto, TX
Click here to add this to my saved trials
Eatontown, New Jersey 07724
2431
mi
from 91732
Eatontown, NJ
Click here to add this to my saved trials
Fullerton, California 92835
12
mi
from 91732
Fullerton, CA
Click here to add this to my saved trials
Miami, Florida 33137
2320
mi
from 91732
Miami, FL
Click here to add this to my saved trials
Naples, Florida 34102
2220
mi
from 91732
Naples, FL
Click here to add this to my saved trials
Quincy, Massachusetts 02169
2581
mi
from 91732
Quincy, MA
Click here to add this to my saved trials
Salt Lake City, Utah 32751
570
mi
from 91732
Salt Lake City, UT
Click here to add this to my saved trials
San Diego, California 92103
?
mi
from 91732
San Diego, CA
Click here to add this to my saved trials
Toms River, New Jersey 08755
2426
mi
from 91732
Toms River, NJ
Click here to add this to my saved trials
Willow Grove, Pennsylvania 19090
2377
mi
from 91732
Willow Grove, PA
Click here to add this to my saved trials