A Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of AVP-786 (deuterated [d6]-dextromethorphan hydrobromide [d6-DM]/quinidine sulfate [Q]) for the treatment of agitation in patients with dementia of the Alzheimer’s type.

Investigator: Elizabeth Crocco

Institutional Protocol #: 20150712

National Clinical Trials Identifier: NCT02442765

Funding Agency/Sponsor: Avanir Pharmaceuticals/ Inc.

Division: Psychiatry

Therapeutic Area: Other

Phase: Phase III

Enrolling Sites: University of Miami Medical Group

Enrolling Since: 7/29/2016


Purpose/Abstract:


Patients with agitation secondary to dementia of the Alzheimer's type. The diagnosis of
probable Alzheimer's disease (AD) will be based on the '2011 Diagnostic Guidelines for
Alzheimer's Disease' issued by the National Institute on Aging (NIA)-Alzheimer's Association
(AA) workgroups.




Eligibility Criteria:


Inclusion Criteria:

- Diagnosis of probable Alzheimer's Disease (AD)

- 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

- Clinical Global Impression of Change (CGIS) score assessing Agitation is >= 4
(moderately ill) at screening and baseline

- 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


Gender: All

Minimum Age: 50 Years

Maximum Age: 90 Years

Accepts healthy volunteers: No

Please note that this is written for scientific review, and if there are any questions or clarifications needed, please contact

Belinda Robertson, Clinical Research Coordinator
(305) 243 2891
b.ryan1@miami.edu

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