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Home » Clinical Trials » Alzheimer's Disease

Clinical Trial Details

Overview

Research Study Summary

A clinical trial to evaluate treatments using AVP-923 (dextromethorphan/quinidine) and Placebo for patients with Agitation or Alzheimer's Disease

Research Study Title

A Phase 2, Randomized, Double-dummy, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety and Tolerability of AVP-923 (Dextromethorphan/Quinidine) for the Treatment of Symptoms of Agitation in Patients With Alzheimer's Disease.

Purpose

The objectives of the study are to evaluate the safety, tolerability and efficacy of AVP-923 compared to placebo, for the treatment of symptoms of agitation in patients with Alzheimer's Disease (AD).

To Learn more
Phase

2

Gender

Both Male and Female

Age

50 to 90 Years

Overall Status

Recruiting

Lead Sponsor

Avanir Pharmaceuticals

Duration

24 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 50 Years to 90 Years

Key Inclusion Criteria:

Diagnosis of probable Alzheimer's disease (AD).

The patient has clinically significant symptoms of agitation secondary to AD, that interfere with daily routine and for which a prescription medication is deemed indicated, in the opinion of the investigator.

Either out-patients or residents of an assisted-living facility or a skilled nursing home.

CGI-S score is ≥ 4 (moderately ill) at screening and baseline.

Mini Mental State Examination (MMSE) score at screening between 8 and 26(inclusive).

Caregiver who is able and willing to comply with all required study procedures, ensuring that the patient attends all study visits and takes the study medication as instructed. Caregiver must spend time with the patient a minimum of 4 times per week on 4 separate days.

Key Exclusion Criteria:

Patient has other type of dementia (e.g., vascular dementia, frontotemporal dementia, Parkinson's disease, substance-induced dementia).

Patients 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, certain cardiac conduction abnormalities including QTc prolongation, or unstable valvular heart disease).

Patients with myasthenia gravis.

Site Locations (39)

Country State City Zip Facility and Contact
United States Arizona Phoenix 85006 Research Site
United States Arizona Sun City 85351 Research Site
United States California Fullerton 92835 Research Site
United States California Los Angeles 90073 Research Site
United States California San Diego 92103 Research Site
United States California San Francisco 94109 Research Site
United States California Sherman Oaks 91403 Research Site
United States California Temecula 92591 Research Site
United States Florida Boynton Beach 33426 Research Site
United States Florida Deerfield Beach 33064 Research Site
United States Florida Hialeah 33012 Research Site
United States Florida Miami 33137 Research Site
United States Florida Miami 33122 Research Site
United States Florida Ocala 34471 Research Site
United States Florida Orlando 32806 Research Site
United States Florida Sunrise 33351 Research Site
United States Florida Tampa 33609 Research Site
United States Florida West Palm Beach 33407 Research Site
United States Florida West Palm Beach 33409 Research Site
United States Florida Weston 33331 Research Site
United States Illinois Elk Grove Village 60007 Research Site
United States Nevada Las Vegas 89106 Research Site
United States New Jersey Toms River 08757 Research Site
United States New York Orangeburg 10962 Research Site
United States New York Rochester 14620 Research Site
United States New York White Plains 10605 Research Site
United States Ohio Centerville 45459 Research Site
United States Ohio Cincinnati 45227 Research Site
United States Ohio Cleveland 44195 Research Site
United States Ohio Columbus 43221 Research Site
United States Ohio Lakewood 44107 Research Site
United States Pennsylvania Allentown 18104 Research Site
United States Pennsylvania Reading 19604 Research Site
United States South Carolina Charleston 29401 Research Site
United States Texas Houston 77030 Research Site
United States Texas San Antonio 78238 Research Site
United States Utah Salt Lake City 84106 Research Site
United States Vermont Bennington 05201 Research Site
United States Washington Spokane 99204 Research Site

Contact

Paul Shin
949.268.5930

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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NCT ID: NCT01584440

Date Last Changed: April 15, 2014

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