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

  • STATUS
    Recruiting
  • End date
    Oct 4, 2023
  • participants needed
    1200
  • sponsor
    Avanir Pharmaceuticals
Updated on 4 September 2021
Investigator
Fred Ledon
Primary Contact
Boston Center for Memory (4.7 mi away) Contact
+296 other location

Summary

This is an extension study of the Phase 3 Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305, which also allows participants from the Phase 2 Study 12-AVR-131 to be included.

Description

Participant has successfully completed Studies 15-AVP-786-301, 15-AVP-786-302, 12-AVR-131, or 17-AVP-786-305.

Participants will be enrolled in the study for approximately 56 weeks (participants who have a follow-up visit 3 months after the last dose of treatment will be enrolled for approximately 64 weeks).

Approximately 1200 participants will be enrolled at approximately 250 centers globally.

All participants enrolled will receive AVP-786; the treatment dose assigned will be masked to the participant, investigator, study staff, and the sponsor.

Details
Condition Agitation in Patients With Dementia of the Alzheimer's Type
Treatment AVP-786
Clinical Study IdentifierNCT02446132
SponsorAvanir Pharmaceuticals
Last Modified on4 September 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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