Brexpiprazole in the Treatment of Subjects with Agitation Associated with Dementia of the Alzheimer’s Type
- Conditions
- Agitation Associated with Dementia of the Alzheimer’s TypeMedDRA version: 17.1Level: PTClassification code 10012271Term: Dementia Alzheimer's typeSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2013-000503-17-SI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 330
The subject population will include male and female subjects between 55 and 90 years of age (inclusive), who are residing in
a dementia unit, nursing home, assisted living facility, or any
other residential care facility providing long-term care, with a
diagnosis of probable Alzheimer’s disease according to the
NINCDS-ADRDA criteria.
Subjects must have a previous magnetic resonance imaging (MRI) or computed tomography (CT).
Subjects must have been residing at their current facility for at least 1 month before screening and be expected to remain at the
same facility for the duration of the trial.
A caregiver who is usually assigned to care for the subject on a regular basis, has sufficient contact to describe the subject’s symptoms, and has direct observation of the subject’s behavior must be identified during the screening period for participation in the interview for the Cohen Mansfield Agitation Inventory (CMAI), Neuropsychiatric Inventory-Nursing Home (NPI-NH), and other applicable trial assessments.
Subjects must have a previous MRI or CT scan, which was performed after the onset of symptoms of dementia, consistent with a diagnosis of Alzheimer’s disease.
Additionally, at both the screening and baseline visits, subjects
must have a Mini-Mental State Examination (MMSE) score of
5 to 22, inclusive, and a score of = 4 on the agitation/aggression
item of the NPI-NH.
The onset of the subject’s symptoms of agitation must be at least 2 weeks prior to the screening visit.
Subjects must require pharmacotherapy for the treatment of
agitation per the investigator’s judgment, after an evaluation for
reversible factors (eg, pain, infection) and trial of nonpharmacological interventions.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 17
Subjects with dementia or other memory impairment
not due to Alzheimer’s disease, such as mixed or
vascular dementia, dementia with Lewy bodies,
Parkinson’s disease dementia, frontotemporal
dementia, substance-induced dementia, or any other
specific non-Alzheimer’s-type dementia; subjects aged
55 years or older with a diagnosis of Down syndrome
Subjects with a previous magnetic resonance imaging
(MRI) or computed tomography (CT) scan performed
after the onset of symptoms of dementia with findings
consistent with a clinically significant central nervous
system disease other than Alzheimer’s disease, such as
vascular changes (eg, cortical stroke, multiple infarcts),
space-occupying lesion (eg, tumor), or other major
structural brain disease.
Subjects with a history of stroke, transient ischemic
attack, or embolism.
Subjects with a history of clinically relevant traumatic
brain injury with neurological sequelae.
Subjects with a history of a deep venous thrombosis
within the 5 years prior to the screening visit.
Subjects with delirium, unless resolved with no
symptoms for at least 30 days prior to the screening
visit.
Subjects with evidence of serious risk of suicide based
on the Sheehan Suicidality Tracking Scale (Sheehan-
STS) or who, in the opinion of the investigator, present
a serious risk of suicide.
Subjects considered in poor general health based on the
investigator’s judgment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the efficacy of flexible dosing of brexpiprazole (dose range of 0.5 to 2 mg/day) with placebo in subjects with agitation associated with dementia of the Alzheimer’s type, as assessed by the Cohen Mansfield Agitation Inventory (CMAI) after 12 weeks of treatment;Secondary Objective: To evaluate the safety and tolerability of flexible dosing of brexpiprazole (dose range of 0.5 to 2 mg/day) compared with placebo in subjects with agitation associated with dementia of the Alzheimer’s type after 12 weeks of treatment.;Primary end point(s): The primary efficacy variable is the change from baseline to<br>Week 12/ET in the CMAI total score;Timepoint(s) of evaluation of this end point: 12 weeks
- Secondary Outcome Measures
Name Time Method