Long Term, Extension Study of the Safety and Efficacy of AVP‑786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

Sponsor ID
15-AVP-786-303
Clinicaltrials.gov ID
NCT02446132
EudraCT ID
2017-002455-29
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Terminated/Withdrawn
Sponsor ID
15-AVP-786-303
Trial Details
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Age
50 - 90 Years
Therapeutic Area
  • Dementia/Alzheimer
    • Sex
    Female & Male
    Trial Dates
    Nov 2015 - Sep 2024
    Healthy Volunteers
    No
    • Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or 17-AVP-786-305. (Note: A delay in enrollment may include delays associated with COVID-19 restrictions.)
    • Participants with a diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working group criteria
    • Either out-patients or residents of an assisted-living facility or a skilled nursing home
    • Participants who delay enrollment must have clinically significant, moderate/severe agitation at least 2 weeks prior to baseline
    • Participants who delay enrollment must have a diagnosis of agitation that must meet the International Psychogeriatric Association (IPA) provisional definition of agitation
    • Participants who delay enrollment must have a Clinical Global Impression of Severity of Illness (CGIS) score assessing Agitation of ≥ 4 (moderately ill) at screening and baseline
    • Participants who delay enrollment must have a Mini-Mental State Examination (MMSE) score between 6 and 26 (inclusive) at screening and baseline
    • 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 determined to have a high imminent risk of falls during the study based on a clinical evaluation by the investigator
    • Participants who are currently using or were on NUEDEXTA® in the 2 weeks preceding baseline

    Study Summary

    This was an extension study of the Phase 3 Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305.

    Additional Study Details

    Phase
    Phase 3
    Study Drug
    Drug: AVP-786
    Type
    Interventional
    Masking
    None (Open Label)
    Estimated Enrollment
    1197
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • * Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or 17-AVP-786-305. (Note: A delay in enrollment may include delays associated with COVID-19 restrictions.)
    • * Participants with a diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working group criteria

    Exclusion Criteria

    • * 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 determined to have a high imminent risk of falls during the study based on a clinical evaluation by the investigator
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or 17-AVP-786-305. (Note: A delay in enrollment may include delays associated with COVID-19 restrictions.)
    • Participants with a diagnosis of probable Alzheimer's Disease (AD) according to the 2011 National Institute on Aging-Alzheimer's Association (NIA-AA) working group criteria
    • Either out-patients or residents of an assisted-living facility or a skilled nursing home
    • Participants who delay enrollment must have clinically significant, moderate/severe agitation at least 2 weeks prior to baseline
    • Participants who delay enrollment must have a diagnosis of agitation that must meet the International Psychogeriatric Association (IPA) provisional definition of agitation
    • Participants who delay enrollment must have a Clinical Global Impression of Severity of Illness (CGIS) score assessing Agitation of ≥ 4 (moderately ill) at screening and baseline
    • Participants who delay enrollment must have a Mini-Mental State Examination (MMSE) score between 6 and 26 (inclusive) at screening and baseline
    Exclusion Criteria:
    • 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 determined to have a high imminent risk of falls during the study based on a clinical evaluation by the investigator
    • Participants who are currently using or were on NUEDEXTA® in the 2 weeks preceding baseline

    Study Documents

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

    Locations

    Location
    Status
    Location
    MD First Research, LLC Site #767
    Chandler, Arizona, United States, 85286
    Status
    N/A
    Location
    NoesisPharma, LLC
    Phoenix, Arizona, United States, 85032
    Status
    N/A
    Location
    Perseverance Research Center, LLC
    Scottsdale, Arizona, United States, 85254
    Status
    N/A
    Location
    Health Initiatives Research
    Fayetteville, Arkansas, United States, 72703
    Status
    N/A
    Location
    Advanced Research Center, Inc. Site #835
    Anaheim, California, United States, 92805
    Status
    N/A
    Location
    ATP Clinical Research, Inc. Site #763
    Costa Mesa, California, United States, 92626
    Status
    N/A
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