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Trial record 6 of 84 for:    agitation and alzheimer's

Efficacy, Safety, and Tolerability of AVP-786 (Deuterated [d6]-Dextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Avanir Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02442778
First received: May 11, 2015
Last updated: July 19, 2016
Last verified: July 2016
  Purpose
Patients with agitation secondary to dementia of the Alzheimer's type. The diagnosis of probable Alzheimer's disease (AD) will be based on the '2011 Diagnostic Guidelines for Alzheimer's Disease' issued by the National Institute on Aging (NIA)-Alzheimer's Association (AA) workgroups.

Condition Intervention Phase
Agitation in Patients With Dementia of the Alzheimer's Type
Drug: AVP-786
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 (Deuterated [d6]-Dextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type.

Resource links provided by NLM:


Further study details as provided by Avanir Pharmaceuticals:

Primary Outcome Measures:
  • Cohen-Mansfield Agitation Inventory (CMAI) Composite Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGIC) Agitation (Global Clinical Status of Agitation on mADCS-CGIC Scale) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Neuropsychiatric Inventory (NPI): Individual Domain and Total NPI Score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • NPI: Agitation/Aggression Caregiver Distress [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Patient Global Impression of Change (PGIC) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Dementia Quality of Life (DEMQOL) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Zarit Burden Scale [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Resource Utilization in Dementia (RUD) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Mini-Mental State Examination (MMSE) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • CMAI (Agitation and Aggression on CMAI Scale) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 325
Study Start Date: September 2015
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo capsules administered twice a day over a 12-week period
Drug: Placebo
Active Comparator: AVP-786 (dose 1)
AVP-786 dose 1 capsules administered twice a day over a 12-week period.
Drug: AVP-786

Detailed Description:

Eligible participants for this study must have a diagnosis of probable AD and must have clinically meaningful agitation secondary to AD.

This is a multicenter, randomized, placebo-controlled study, consisting of 12 weeks of treatment.

Approximately 325 participants will be enrolled at approximately 50 centers in North America.

Study medication will be administered orally twice-daily from Day 1 through Day 85. Screening must occur within 4 weeks prior to randomization. Following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of probable Alzheimer's Disease (AD)
  • The participant has clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to randomization
  • The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation
  • Either out patients or residents of an assisted-living facility or a skilled nursing home
  • Clinical Global Impression of Severity (CGIS) score assessing Agitation is >=4 (moderately ill) at screening and baseline
  • Mini-Mental State Examination (MMSE) score is between 6 and 26 (inclusive) at screening and baseline
  • Caregiver who is able and willing to comply with all required study procedures. In order to qualify as a reliable informant (i.e., caregiver) capable of assessing changes in participant's condition during the study, the individual must spend a minimum of 2 hours per day for 4 days per week with the participant.

Exclusion Criteria:

  • Participant has dementia predominantly of non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)
  • Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy, poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)
  • Participant with myasthenia gravis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02442778

Contacts
Contact: Uyen Nguyen unguyen@avanir.com
Contact: Paul Shin pshin@avanir.com

  Show 50 Study Locations
Sponsors and Collaborators
Avanir Pharmaceuticals
  More Information

Responsible Party: Avanir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02442778     History of Changes
Other Study ID Numbers: 15-AVP-786-302 
Study First Received: May 11, 2015
Last Updated: July 19, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psychomotor Agitation
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Tauopathies
Neurodegenerative Diseases
Quinidine
Quinidine gluconate
Dextromethorphan
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 30, 2016