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Trial record 2 of 2 for:    Otsuka 331-14-213

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

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ClinicalTrials.gov Identifier: NCT03548584
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : June 7, 2018
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

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

Condition or disease Intervention/treatment Phase
Agitaton Associated With Alzheimer's Dementia Alzheimer Dementia Drug: Brexpiprazole Other: Placebo Phase 3

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 16, 2018
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: Low Dose Brexpiprazole Arm
Tablet
Drug: Brexpiprazole
Tablet
Other Name: OPC-34712

Experimental: High Dose Brexpiprazole Arm
Tablet
Drug: Brexpiprazole
Tablet
Other Name: OPC-34712

Placebo Comparator: Placebo
Tablet
Other: Placebo
Tablet




Primary Outcome Measures :
  1. Cohen-Mansfield Agitation Inventory (CMAI) total score [ Time Frame: From baseline to week 12 visit ]
    Change from baseline to Week 12; assesses frequency of agitated behaviors in elderly persons. The scale consists of 29 agitated behaviors that are further categorized into distinct agitation syndromes, also known as CMAI factors of agitation. Each of the agitated behaviors are scored 1 (never) to 7 (several times an hours), with the total scale score ranging from 29 to 203. The higher the value, the more frequent an agitated behavior has occurred.


Secondary Outcome Measures :
  1. Clinical Global Impression Severity of Illness (CGI-S) score [ Time Frame: From baseline to week 12 visit ]
    Change from baseline to week 12, as related to agitation. CGI-S will be used to rate the severity of agitation. Score ranges from 0 (not assessed) to 7 (among the most extremely ill subjects). The higher the value, the more severe the agitation.



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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548584


Contacts
Contact: Rozina Jadoon +1 (919) 418-6218 rozina.jadoon@syneoshealth.com

Locations
United States, California
ATP Clinical Research Inc. Recruiting
Costa Mesa, California, United States, 92626
Neurology Center of North Orange County Recruiting
Fullerton, California, United States, 92835
United States, Florida
Arocha Research Center Recruiting
Coral Gables, Florida, United States, 33134
Research in Miami Inc. Recruiting
Hialeah, Florida, United States, 33013
Galiz Research Recruiting
Hialeah, Florida, United States, 33016
MaxBlue Institute Recruiting
Hialeah, Florida, United States, 33018
Premier Clinical Research Recruiting
Miami, Florida, United States, 33122
United States, North Carolina
Richard H. Weisler, MD PA Associates Recruiting
Raleigh, North Carolina, United States, 27609
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
H. Lundbeck A/S

Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT03548584     History of Changes
Other Study ID Numbers: 331-14-213
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Agitation

Additional relevant MeSH terms:
Dementia
Alzheimer Disease
Psychomotor Agitation
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Brexpiprazole
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents