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

Sponsor ID
17-AVP-786-305
Clinicaltrials.gov ID
NCT03393520
EudraCT ID
2017-001339-38
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
17-AVP-786-305
Trial Details
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Age
50 - 90 Years
Therapeutic Area
  • Dementia/Alzheimer
    • Sex
    Female & Male
    Trial Dates
    Oct 2017 - Nov 2023
    Healthy Volunteers
    No
    • Diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working groups criteria
    • Participants with clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to baseline that interferes with their daily routine and for which a prescription medication has been indicated, in the opinion of the investigator
    • The diagnosis of agitation must meet the provisional consensus definition of agitation in participants with cognitive disorders developed by the International Psychogeriatric Association (IPA) Agitation Definition Work Group.
    • A Clinical Global Impression of Severity of Illness scale for Agitation (CGIS-Agitation) score of ≥ 4 (moderately ill) at screening and baseline
    • Participants must have a reliable caregiver who is able and willing to comply with study procedures, including not administering any prohibited medications during the course of the study.
    • 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.
    • Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)
    • Participants with symptoms of agitation that are not secondary to AD (e.g., secondary to pain, other psychiatric disorder, or delirium)
    • 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)
    • Participants with myasthenia gravis

    Study Summary

    This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.

    Additional Study Details

    Phase
    Phase 3
    Study Drug
    Drug: Placebo
    Type
    Interventional
    Masking
    Quadruple
    Estimated Enrollment
    601
    Additional Study Details

    Inclusion and Exclusion 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
    • * Participants with clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to baseline that interferes with their daily routine and for which a prescription medication has been indicated, in the opinion of the investigator

    Exclusion Criteria

    • * Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)
    • * Participants with symptoms of agitation that are not secondary to AD (e.g., secondary to pain, other psychiatric disorder, or delirium)
    Inclusion and Exclusion 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
    • Participants with clinically significant, moderate/severe agitation at the time of screening and for at least 2 weeks prior to baseline that interferes with their daily routine and for which a prescription medication has been indicated, in the opinion of the investigator
    • The diagnosis of agitation must meet the provisional consensus definition of agitation in participants with cognitive disorders developed by the International Psychogeriatric Association (IPA) Agitation Definition Work Group.
    • A Clinical Global Impression of Severity of Illness scale for Agitation (CGIS-Agitation) score of ≥ 4 (moderately ill) at screening and baseline
    • Participants must have a reliable caregiver who is able and willing to comply with study procedures, including not administering any prohibited medications during the course of the study.
    • 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:
    • Participants with dementia predominantly of the non-Alzheimer's type (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia)
    • Participants with symptoms of agitation that are not secondary to AD (e.g., secondary to pain, other psychiatric disorder, or delirium)
    • 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)
    • Participants with myasthenia gravis

    Locations

    Location
    Status
    Location
    MD First Research #767
    Chandler, Arizona, United States, 85286
    Status
    N/A
    Location
    Liv Generations of Agritopia / CCT #573
    Gilbert, Arizona, United States, 85296
    Status
    N/A
    Location
    Liv Generations of Ahwatukee / CCT #784
    Phoenix, Arizona, United States, 85048
    Status
    N/A
    Location
    Perseverance Research Center
    Scottsdale, Arizona, United States, 85254
    Status
    N/A
    Location
    Medical Advancement Center of Arizona #820
    Tempe, Arizona, United States, 85283
    Status
    N/A
    Location
    Clinical Trials Inc.
    Little Rock, Arkansas, United States, 72205
    Status
    N/A
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