An Evaluation of Three Doses of NS 2330 in Patients With Mild to Moderate Dementia of the Alzheimer's Type
- Conditions
- Alzheimer Disease
- Registration Number
- NCT00153010
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Objectives: The objective of this study will be to determine the safety, tolerability, drug blood levels, and efficacy of each of three doses of NS 2330 (Tesofensine) given once daily compared with placebo in patients with mild to moderate Dementia of the Alzheimer's Type.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 430
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Changes in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) week 0, 4, 9, 14 and 20
- Secondary Outcome Measures
Name Time Method ADAS-Cog total score including Extension weeks 0, 4, and 14 types and frequencies of adverse events 20 weeks proportion of patients discontinued from the trial because of adverse events 20 weeks changes from baseline in vital signs 20 weeks changes from baseline in laboratory measurements 20 weeks Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change weeks 0 and 14 Alzheimer's Disease Cooperative Study-Activities of Daily Living weeks 0, 4, and 14 Neuropsychiatric Inventory weeks 0, 4, and 14 Mini-Mental State Examination weeks 0 and 14 ADAS-Cog Extension weeks 0, 4, 9, 14 and 20 changes from baseline in ECG readings 20 weeks comparison of study groups for drug plasma concentrations weeks 0, 4, 9, 14 and 20 population PK parameters Weeks 0, 4, 9, 14 and 20
Trial Locations
- Locations (76)
Margolin Brain Institute
🇺🇸Fresno, California, United States
Southwest Institute for Clinical Research
🇺🇸Rancho Mirage, California, United States
North Michigan Neurology
🇺🇸Traverse City, Michigan, United States
Torrance Clinical Research
🇺🇸Torrance, California, United States
Neurologic Consulting/PA
🇺🇸Fort Lauderdale, Florida, United States
St. Louis University
🇺🇸St. Louis, Missouri, United States
Neurological Associates of Albany
🇺🇸Albany, New York, United States
Upstate Clinical Research
🇺🇸Albany, New York, United States
Independent Psychiatric Consultants
🇺🇸Waukesha, Wisconsin, United States
Baylor College of Medicine VA Medical Center
🇺🇸Houston, Texas, United States
University of Texas Medical Science Institute
🇺🇸Houston, Texas, United States
Optimum Health Services
🇺🇸Oceanside, California, United States
Palm Beach Neurology/Premier Research Institute
🇺🇸W. Palm Beach, Florida, United States
LaGrange Hospital
🇺🇸LaGrange, Illinois, United States
Health Quest Clinical Trials
🇺🇸San Diego, California, United States
Baumel-Eisner Neuromedical Institute
🇺🇸Miami, Florida, United States
Miami Jewish Home and Hospital for the Aged
🇺🇸Miami, Florida, United States
University of Nevada School of Medicine
🇺🇸Las Vegas, Nevada, United States
Xenoscience
🇺🇸Phoenix, Arizona, United States
Institute on Aging Research Center
🇺🇸San Francisco, California, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Psychiatric Consultants
🇺🇸Nashville, Tennessee, United States
Integra Clinical Research
🇺🇸San Antonio, Texas, United States
California Clinical Trials Medical Group
🇺🇸Culver City, California, United States
Care@ Granada Hills Community Hospital
🇺🇸Granada Hills, California, United States
Neurology Associates PA
🇺🇸Wilmington, Delaware, United States
Clinical Physiology Associates Study Center
🇺🇸Fort Meyers, Florida, United States
Magnolia Research Group
🇺🇸Ocala, Florida, United States
Segal Institute for Clinical Research
🇺🇸N. Miami, Florida, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
University of Iowa College of Medicine
🇺🇸Iowa City, Iowa, United States
Agewell, Ltd.
🇺🇸Indianapolis, Indiana, United States
Attn: M. Lannom, RN, MS
🇺🇸Sharon, Massachusetts, United States
Future Care Studies
🇺🇸Springfield, Massachusetts, United States
Saginaw Cooperative Hosp. Inc./ Internal medicine
🇺🇸Saginaw, Michigan, United States
Atlantic Coast Research
🇺🇸Tom's River, New Jersey, United States
Dent Neurologic Institute
🇺🇸Amherst, New York, United States
Social Psychiatry Research Institute
🇺🇸New York, New York, United States
Eastside Comprehensive Medical Services
🇺🇸New York, New York, United States
The Jewish Home and Hospital
🇺🇸New York, New York, United States
North Coast Clinical Trials, Inc.
🇺🇸Beachwood, Ohio, United States
Neurology Center of Ohio
🇺🇸Toledo, Ohio, United States
Triangle Medical Research
🇺🇸Lexington Road, North Carolina, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
Butler Hospital Dept. of Neurology
🇺🇸Providence, Rhode Island, United States
PRO Research
🇺🇸Eugene, Oregon, United States
Pearl Clinical Research, Inc.
🇺🇸Norristown, Pennsylvania, United States
The Clinical Trial Center, LLC
🇺🇸Jenkintown, Pennsylvania, United States
Crosswords Counseling and Consulting Associates
🇺🇸Moon Township, Pennsylvania, United States
Rhode Island Mood and Memory Research Institute
🇺🇸E. Providence, Rhode Island, United States
Caprock Clinical Trials Center
🇺🇸Lubbock, Texas, United States
Grayline Clinical Drug Trials
🇺🇸Wichita Falls, Texas, United States
Pasqua Hospital
🇨🇦Regina, Saskatchewan, Canada
UVA Dept. of Neurology
🇺🇸Charlottesville, Virginia, United States
The Memory Clinic/Southwestern Vermont Medical Center
🇺🇸Bennington, Vermont, United States
Clinical Research Consultant Group
🇨🇦Beaconsfield, Quebec, Canada
Infectious Disease
🇨🇦Moncton, New Brunswick, Canada
University of Missouri
🇺🇸Columbia, Missouri, United States
Sunrise Clinical Research
🇺🇸Hollywood, Florida, United States
Memory Disorder Clinic
🇺🇸Pompano Beach, Florida, United States
Berma Research Group
🇺🇸Hialeah, Florida, United States
Peryam and Kroll Healthcare Research
🇺🇸Chicago, Illinois, United States
Oregon Center for Clinical Investigators, Inc.
🇺🇸Eugene, Oregon, United States
Associated Neurologists PC - Danbury
🇺🇸Danbury, Connecticut, United States
Boehringer Ingelheim Investigational Site
🇨🇦Greenfield Park, Quebec, Canada
Center for Geriatric & Adult Psychiatry
🇺🇸Hamden, Connecticut, United States
Pivotal Research Center
🇺🇸Peoria, Arizona, United States
Medical Univ. of South Carolina, Alzheimer's Research
🇺🇸N Charleston., South Carolina, United States
USF Suncoast Gerontology Center
🇺🇸Tampa, Florida, United States
Linden Research Consultants
🇺🇸Oklahoma City, Oklahoma, United States
Pahl Brain Associates
🇺🇸Oklahoma City, Oklahoma, United States
Attn: Valerie MacDonald
🇺🇸Portland, Oregon, United States
Albuquerque Neuroscience
🇺🇸Albuquerque, New Mexico, United States
Louisiana State University Medical Center
🇺🇸New Orleans, Louisiana, United States
Associates in Neurology-Research
🇺🇸Lexington, Kentucky, United States
Hartford Research Group
🇺🇸Florence, Kentucky, United States