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

Sponsor ID
20-AVP-786-307
Clinicaltrials.gov ID
NCT04464564
EudraCT ID
2020-000799-39
EUCTIS ID
2023-504991-31-00
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Terminated/Withdrawn
Sponsor ID
20-AVP-786-307
Trial Details
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Age
50 - 90 Years
Therapeutic Area
  • Dementia/Alzheimer
    • Sex
    Female & Male
    Trial Dates
    Sep 2020 - Jun 2024
    Healthy Volunteers
    No
    • Participants with a diagnosis of probable Alzheimer's disease according to the 2011 Neuropsychiatric Inventory Agitation/Aggression (NPI-AA) working groups criteria
    • Participants with clinically significant, moderate-to-severe agitation for at least 2 weeks prior to Screening that interferes with daily routine per the Investigator's judgment
    • Participants who require pharmacotherapy for the treatment of agitation per the Investigator's judgment after an evaluation of reversible factors and a course of nonpharmacological interventions
    • Diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation.
    • Participants meeting an additional predetermined blinded eligibility criterion, which will remain blinded to the clinical study site Investigators and staff
    • Participants with a reliable caregiver who is able and willing to comply with all study procedures, including adherence to administering study drug and not administering any prohibited medications during the course of the study, and who spends 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 Alzheimer's dementia (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 \[except skin basal-cell carcinoma\], 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 was conducted to evaluate the efficacy, safety, and tolerability of AVP-786 (deudextromethorphan hydrobromide \[d6-DM\]/quinidine sulfate \[Q\]) 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: AVP-786
    Type
    Interventional
    Masking
    Quadruple
    Estimated Enrollment
    241
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • * Participants with a diagnosis of probable Alzheimer's disease according to the 2011 Neuropsychiatric Inventory Agitation/Aggression (NPI-AA) working groups criteria
    • * Participants with clinically significant, moderate-to-severe agitation for at least 2 weeks prior to Screening that interferes with daily routine per the Investigator's judgment

    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 Alzheimer's dementia (e.g., secondary to pain, other psychiatric disorder, or delirium)
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • Participants with a diagnosis of probable Alzheimer's disease according to the 2011 Neuropsychiatric Inventory Agitation/Aggression (NPI-AA) working groups criteria
    • Participants with clinically significant, moderate-to-severe agitation for at least 2 weeks prior to Screening that interferes with daily routine per the Investigator's judgment
    • Participants who require pharmacotherapy for the treatment of agitation per the Investigator's judgment after an evaluation of reversible factors and a course of nonpharmacological interventions
    • Diagnosis of agitation must meet the International Psychogeriatric Association (IPA) provisional definition of agitation.
    • Participants meeting an additional predetermined blinded eligibility criterion, which will remain blinded to the clinical study site Investigators and staff
    • Participants with a reliable caregiver who is able and willing to comply with all study procedures, including adherence to administering study drug and not administering any prohibited medications during the course of the study, and who spends 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 Alzheimer's dementia (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 \[except skin basal-cell carcinoma\], 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 Documents

    Study Protocol
    Available Languages: English
    DOWNLOAD DOCUMENT(S)
    Statistical Analysis Plan
    Available Languages: English
    DOWNLOAD DOCUMENT(S)
    Plain Language Summary
    Available Languages: English
    DOWNLOAD DOCUMENT(S)

    Locations

    Location
    Status
    Location
    Clinical Research Site #840-020
    Phoenix, Arizona, United States, 85004
    Status
    N/A
    Location
    Clinical Research Site #840-047
    Anaheim, California, United States, 92805
    Status
    N/A
    Location
    Clinical Research Site #840-090
    Costa Mesa, California, United States, 92626
    Status
    N/A
    Location
    Clinical Research Site #840-059
    Lafayette, California, United States, 94549
    Status
    N/A
    Location
    Clinical Research Site #840-048
    Lomita, California, United States, 90717
    Status
    N/A
    Location
    Clinical Research Site #840-095
    Long Beach, California, United States, 90807
    Status
    N/A
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