A Trial to Evaluate the Safety, Efficacy, and Tolerability of Brexpiprazole in Treating Agitation Associated With Dementia of the Alzheimer's Type



Status:Recruiting
Conditions:Alzheimer Disease, Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:55 - 90
Updated:1/31/2019
Start Date:May 16, 2018
End Date:December 2020

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

A Phase 3, 12-Week, Multicenter, Randomized, Double-blind, Placebo-controlled, 2-Arm, Fixed-dose Trial to Evaluate the Efficacy, Safety, and Tolerability of Brexpiprazole (OPC-34712) in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type

This study compares the efficacy of 2 doses of brexpiprazole with placebo in subjects with
agitation associated with dementia of the Alzheimer's type.

This is a phase 3, 12-week, multicenter, randomized, double-blind, placebo-controlled,
fixed-dose trial designed to assess the efficacy, safety, and tolerability of brexpiprazole
compared with placebo. The trial consists of a 12-week double-blind treatment period with a
30 day follow-up. The trial population will include male and female subjects between 55 and
90 years of age (inclusive) with a diagnosis of probable Alzheimer's disease, who are
residing either in an institutionalized setting or in a non-institutionalized setting where
the subject is not living alone. This trial will analyze data gathered from 225 subjects at
multiple countries. Subjects may also be eligible to enter an active extension trial,
following completion of this trial.

Inclusion Criteria:

- Subjects with a diagnosis of probable Alzheimer's disease.

- Subjects with a diagnosis of agitation

- Subjects with a MMSE score of 5 to 22, inclusive, at screening and baseline visits.

- Subjects with a previous MRI or CT scan of the brain, that was performed after the
onset of symptoms of dementia, with findings consistent with a diagnosis of
Alzheimer's disease.

- Subjects who are residing at their current location for at least 28 days before
screening and are expected to remain at the same location for the duration of the
trial.

- Institutionalized subjects with an identified caregiver who has sufficient contact
(minimum of 2 hours per day for 4 days per week) to describe the subject's symptoms
and has direct observation of the subject's behavior. Non-institutionalized subjects
may not be living alone and must have an identified caregiver who has sufficient
contact (minimum of 2 hours per day for 4 days per week) to describe the subject's
symptoms and has direct observation of the subject's behavior.

- Subjects with onset of symptoms of agitation at least 2 weeks prior to screening
visit.

- Subjects will and able to discontinue all prohibited concomitant medications to meet
protocol required washouts prior to and during the trial period.

Exclusion Criteria:

- Subjects with dementia or other memory impairment not due to Alzheimer's disease.

- Subjects with a history of stroke, well-documented transient ischemic attack, or
pulmonary or cerebral embolism.

- Subjects who had an insufficient response, based on the investigator's judgment, to 2
or more previous antipsychotic medications.

- Subjects who have been diagnosed with an Axis I disorder.

- Subjects who currently have clinically significant neurological, hepatic, renal,
metabolic, hematological, immunological, cardiovascular, pulmonary, gastrointestinal,
or psychiatric disorders.

- Subjects with uncontrolled hypertension or symptomatic hypotension, or orthostatic
hypotension.

- Subjects with diabetes mellitus (insulin-dependent and non-insulin-dependent) may be
eligible for the trial if their condition is stable and well-controlled.
We found this trial at
33
sites
Miami, Florida 33122
Phone: 305-392-0279
?
mi
from
Miami, FL
Click here to add this to my saved trials
Allentown, Pennsylvania 18104
?
mi
from
Allentown, PA
Click here to add this to my saved trials
Ann Arbor, Michigan 48105
Phone: 734-834-8954
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Beaumont, Texas 77701
Phone: 409-331-6040
?
mi
from
Beaumont, TX
Click here to add this to my saved trials
Bradenton, Florida 34209
Phone: 941-792-6564
?
mi
from
Bradenton, FL
Click here to add this to my saved trials
Brooklyn, New York 11229
Phone: 718-444-7774
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
?
mi
from
Burgas,
Click here to add this to my saved trials
Chandler, Arizona 85226
Phone: 480-353-6462
?
mi
from
Chandler, AZ
Click here to add this to my saved trials
Coral Gables, Florida 33134
Phone: 786-587-9425
?
mi
from
Coral Gables, FL
Click here to add this to my saved trials
Coral Gables, Florida 33134
Phone: 305-702-1594
?
mi
from
Coral Gables, FL
Click here to add this to my saved trials
Costa Mesa, California 92626
Phone: 714-277-4472
?
mi
from
Costa Mesa, CA
Click here to add this to my saved trials
Costa Mesa, California 92627
Phone: 949-660-8211
?
mi
from
Costa Mesa, CA
Click here to add this to my saved trials
Flowood, Mississippi 39232
Phone: 601-420-5811
?
mi
from
Flowood, MS
Click here to add this to my saved trials
Fullerton, California 92835
Phone: 714-879-7200
?
mi
from
Fullerton, CA
Click here to add this to my saved trials
1055 East 4th Avenue
Hialeah, Florida 33013
Phone: 305-889-6670
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Hialeah, Florida 33016
Phone: 305-805-0921
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Hialeah, Florida 33018
Phone: 305-819-2909
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
Houston, Texas 77062
Phone: 281-282-0808
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77084
Phone: 281-944-3610
?
mi
from
Houston, TX
Click here to add this to my saved trials
Kissimmee, Florida 34759
Phone: 407-932-1977
?
mi
from
Kissimmee, FL
Click here to add this to my saved trials
Lakewood, California 90805
Phone: 714-717-6039
?
mi
from
Lakewood, CA
Click here to add this to my saved trials
Los Angeles, California 90036
Phone: 310-289-8242
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Miami, Florida 33155
Phone: 305-643-8400
?
mi
from
Miami, FL
Click here to add this to my saved trials
Palmetto Bay, Florida
Phone: 786-310-7477
?
mi
from
Palmetto Bay, FL
Click here to add this to my saved trials
Pasadena, California 91105
Phone: 626-250-2070
?
mi
from
Pasadena, CA
Click here to add this to my saved trials
Pensacola, Florida 32514
Phone: 850-474-2081
?
mi
from
Pensacola, FL
Click here to add this to my saved trials
Raleigh, North Carolina 27609
Phone: 919-872-5900
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Saint Louis, Missouri 63118
Phone: 314-230-4326
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Suwanee, Georgia 30024
Phone: 770-814-9455
?
mi
from
Suwanee, GA
Click here to add this to my saved trials
Toms River, New Jersey 08755
Phone: 732-244-2299
?
mi
from
Toms River, NJ
Click here to add this to my saved trials
Tucson, Arizona 85704
Phone: 520-742-1833
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
2229 North Commerce Parkway
Weston, Florida 33326
Phone: 786-773-2737
?
mi
from
Weston, FL
Click here to add this to my saved trials
Winchester, Massachusetts 01890
Phone: 617-639-5006
?
mi
from
Winchester, MA
Click here to add this to my saved trials