Participants with agitation secondary to dementia of the Alzheimer's type

  • STATUS
    Recruiting
  • sponsor
    Avanir
Updated on 29 July 2021
dementia
mini-mental state examination
mental state examination
agitation

Summary

Participants with agitation secondary to dementia of the Alzheimer's type. Eligible participants for this study must have a diagnosis of probable AD and must have clinically meaningful agitation secondary to AD.

Description


Details
Condition Alzheimer's Disease, Memory Loss, Memory Problems
Clinical Study IdentifierTX278580
SponsorAvanir
Last Modified on29 July 2021

Eligibility

Yes No Not Sure

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
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
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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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