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Trial record 2 of 2 for:    15-AVP-786-302

Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

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ClinicalTrials.gov Identifier: NCT02442778
Recruitment Status : Recruiting
First Posted : May 13, 2015
Last Update Posted : May 24, 2018
Sponsor:
Information provided by (Responsible Party):
Avanir Pharmaceuticals

Brief Summary:
Participants 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 or disease Intervention/treatment Phase
Agitation in Patients With Dementia of the Alzheimer's Type Drug: AVP-786 Drug: Placebo Phase 3

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 470 participants will be enrolled at approximately 75 centers in North America.

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 470 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
Study Start Date : September 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo capsules administered twice a day over a 12-week period
Drug: Placebo
Experimental: AVP-786 (dose 1)
AVP-786 dose 1; capsules administered twice a day over a 12-week period
Drug: AVP-786
Experimental: AVP-786 (dose 2)
AVP-786 dose 2; capsules administered twice a day over a 12-week period
Drug: AVP-786



Primary Outcome Measures :
  1. Change from Baseline to Week 12 in the Cohen-Mansfield Agitation Inventory (CMAI) Composite Score [ Time Frame: Baseline; Week 12; Follow-up Visit (30 days post last dose of study medication for participants who terminate early) ]

Secondary Outcome Measures :
  1. Change from Baseline to Week 12 in the Modified Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (mADCS-CGIC)-Agitation (Global Clinical Status of Agitation on mADCS-CGIC Scale) Score [ Time Frame: Baseline; Week 12; Follow-up Visit (30 days post last dose of study medication for participants who terminate early) ]
  2. Change from Baseline to Week 12 in the Neuropsychiatric Inventory (NPI) Agitation/Aggression Domain Score [ Time Frame: Baseline; Week 12 ]
  3. Change from Baseline to Week 12 in the NPI Caregiver Distress Score [ Time Frame: Baseline; Week 12 ]
  4. Change from Baseline to Week 12 in the NPI Aberrant Motor Behavior Domain Score [ Time Frame: Baseline; Week 12 ]
  5. Change from Baseline to Week 12 in the Zarit Burden Interview (ZBI) Score [ Time Frame: Baseline; Week 12 ]
  6. Change from Baseline to Week 12 in the NPI Irritability/Lability Domain Score [ Time Frame: Baseline; Week 12 ]
  7. Change from Baseline to Week 12 in the NPI Total Score [ Time Frame: Baseline; Week 12 ]
  8. Change from Baseline to Week 12 in the Clinical Global Impression of Severity of Illness (CGIS)-Agitation Domain Score [ Time Frame: Baseline; Week 12 ]
  9. Change from Baseline to Week 12 in the Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change (ADCS-CGIC) Overall Rating [ Time Frame: Baseline; Week 12 ]
  10. Change from Baseline to Week 12 in the Patient Global Impression of Change (PGIC) Score [ Time Frame: Baseline; Week 12 ]
    PGIC (rated by caregiver)

  11. Change from Baseline to Week 12 in the Dementia Quality of Life (DEMQOL) Score [ Time Frame: Baseline; Week 12 ]
  12. Change from Baseline in the Cornell Scale for Depression in Dementia (CSDD) Score [ Time Frame: Baseline; Week 12 ]
  13. Change from Baseline to Week 12 in the General Medical Health Rating (GMHR) Score [ Time Frame: Baseline; Week 12 ]
  14. Change from Baseline to Week 12 in the Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score [ Time Frame: Baseline; Week 12 ]
  15. Change from Baseline in the Resource Utilization in Dementia (RUD) Score [ Time Frame: Baseline; Week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria
  • 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 of Illness (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

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): NCT02442778


Contacts
Contact: Uyen Nguyen unguyen@avanir.com
Contact: Nadine Knowles nknowles@avanir.com

  Show 74 Study Locations
Sponsors and Collaborators
Avanir Pharmaceuticals

Responsible Party: Avanir Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02442778     History of Changes
Other Study ID Numbers: 15-AVP-786-302
First Posted: May 13, 2015    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018

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

Additional relevant MeSH terms:
Dementia
Psychomotor Agitation
Alzheimer Disease
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
Dextromethorphan
Antitussive Agents
Respiratory System Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs