An Evaluation of Three Doses of NS 2330 in Patients With Mild to Moderate Dementia of the Alzheimer's Type

NCT00153010 | Completed Phase 2

• 1 other identifier: 1198.52
• Study Type: interventional
• Target: 430
• Locations: 2 countries
• Sites: 87

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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• Changes in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)

  week 0, 4, 9, 14 and 20

Secondary Outcomes (13)

• 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

Interventions

NS 2330 (Tesofensine) DRUG

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients may be included in this study if they meet all of the following criteria:
• Male, and female without child bearing potential between 40 and 85 years of age, inclusive. Women who have been postmenopausal for less than 2 years must have a negative pregnancy test at screening.
• Diagnosis of probable mild to moderate Dementia of the Alzheimer's Type as defined by National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS ADRDA) guidelines.9
• Mini-Mental State Examination (MMSE) score of 10-24 and Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) score greater than 12 at screening.
• Modified Hachinski Scale10 score no greater than 4.

You may not qualify if:

• Exhibits reliability and physiologic capability sufficient to comply with all protocol procedures. Patient must be familiar with and fluent in English (i.e., sufficient to complete all study assessments from the language perspective).
• Patients and/or a legal representative and their caregivers must have given informed consent. The legal representative and caregiver may be the same person.
• Patient must have a reliable caregiver that is in frequent or daily contact with the patient, who will accompany the patient to the office and who will monitor the administration of prescribed medications. The caregiver will be able to communicate in English and be willing to comply with protocol requirements.
• Patients must be excluded from this study if they meet any of the following criteria:
• Secondary disorders inducing dementia such as neurosyphilis, craniocerebral trauma (CT/MRI), hyperthyroidism, or folic acid deficiency.
• History of malignancy within 3 years, except for basal cell carcinoma.
• History or diagnosis of symptomatic and/or unstable/uncontrolled:
• Cardiovascular illnesses such as chronic congestive heart failure (with or without edema), arrhythmias, labile hypertension, ischemic heart disease, myocardial infarction (with residual angina), orthopnea, conduction defects (ECG), or other heart disease classified NYHA III or IV.
• Liver disease such as cirrhosis, hepatitis B, hepatitis C, or primary or metastatic neoplasm.
• Gastrointestinal disorder such as GI bleeding, malabsorption syndromes, post-gastrectomy, or active peptic ulcer disease.
• Renal disease (primary or secondary) such as chronic renal failure (CLCR \< 30 mL/min).
• Endocrine disease such as diabetes mellitus or hypothyroidism.
• Neurological disease (other than Dementia of the Alzheimer's Type such as Huntington's disease, Parkinson's disease, encephalitis, epilepsy, stroke, or multiple sclerosis) and psychiatric disorders such as schizophrenia, major depression, or mental retardation.
• Significant pulmonary disease predisposing to hypoxia.
• Immunological disorder such as clinically significant allergies, Lupus erythematosis, or scleroderma.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (87)

Pivotal Research Center

Mesa, Arizona, United States

Location

Pivotal Research Center

Peoria, Arizona, United States

Location

Xenoscience

Phoenix, Arizona, United States

Location

Boehringer Ingelheim Investigational Site

Berkeley, California, United States

Location

California Clinical Trials Medical Group

Culver City, California, United States

Location

Margolin Brain Institute

Fresno, California, United States

Location

Care@ Granada Hills Community Hospital

Granada Hills, California, United States

Location

Optimum Health Services

La Mesa, California, United States

Location

Optimum Health Services

Oceanside, California, United States

Location

Southwest Institute for Clinical Research

Rancho Mirage, California, United States

Location

Health Quest Clinical Trials

San Diego, California, United States

Location

Institute on Aging Research Center

San Francisco, California, United States

Location

Torrance Clinical Research

Torrance, California, United States

Location

Associated Neurologists PC - Danbury

Danbury, Connecticut, United States

Location

Center for Geriatric & Adult Psychiatry

Hamden, Connecticut, United States

Location

Neurology Associates PA

Wilmington, Delaware, United States

Location

Baumel-Eisner Neuromedical Institute

Boca Raton, Florida, United States

Location

Baumel-Eisner Neuromedical Institute

Fort Lauderdale, Florida, United States

Location

Neurologic Consulting/PA

Fort Lauderdale, Florida, United States

Location

Clinical Physiology Associates Study Center

Fort Meyers, Florida, United States

Location

Berma Research Group

Hialeah, Florida, United States

Location

Sunrise Clinical Research

Hollywood, Florida, United States

Location

Baumel-Eisner Neuromedical Institute

Miami, Florida, United States

Location

Miami Jewish Home and Hospital for the Aged

Miami, Florida, United States

Location

Segal Institute for Clinical Research

North Miami, Florida, United States

Location

Magnolia Research Group

Ocala, Florida, United States

Location

Memory Disorder Clinic

Pompano Beach, Florida, United States

Location

Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Location

USF Suncoast Gerontology Center

Tampa, Florida, United States

Location

Palm Beach Neurology/Premier Research Institute

West Palm Beach, Florida, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Location

Peryam and Kroll Healthcare Research

Chicago, Illinois, United States

Location

LaGrange Hospital

LaGrange, Illinois, United States

Location

Agewell, Ltd.

Indianapolis, Indiana, United States

Location

University of Iowa College of Medicine

Iowa City, Iowa, United States

Location

Hartford Research Group

Florence, Kentucky, United States

Location

Associates in Neurology-Research

Lexington, Kentucky, United States

Location

Louisiana State University Medical Center

New Orleans, Louisiana, United States

Location

Attn: M. Lannom, RN, MS

Sharon, Massachusetts, United States

Location

Future Care Studies

Springfield, Massachusetts, United States

Location

Saginaw Cooperative Hosp. Inc./ Internal medicine

Saginaw, Michigan, United States

Location

North Michigan Neurology

Traverse City, Michigan, United States

Location

University of Missouri

Columbia, Missouri, United States

Location

St. Louis University

St Louis, Missouri, United States

Location

University of Nevada School of Medicine

Las Vegas, Nevada, United States

Location

Atlantic Coast Research

Toms River, New Jersey, United States

Location

Albuquerque Neuroscience

Albuquerque, New Mexico, United States

Location

Neurological Associates of Albany

Albany, New York, United States

Location

Upstate Clinical Research

Albany, New York, United States

Location

Dent Neurologic Institute

Amherst, New York, United States

Location

Eastside Comprehensive Medical Services

New York, New York, United States

Location

Social Psychiatry Research Institute

New York, New York, United States

Location

The Jewish Home and Hospital

New York, New York, United States

Location

Duke University Medical Center

Durham, North Carolina, United States

Location

Triangle Medical Research

Lexington Road, North Carolina, United States

Location

Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Location

North Coast Clinical Trials, Inc.

Beachwood, Ohio, United States

Location

Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, United States

Location

Neurology Center of Ohio

Toledo, Ohio, United States

Location

Linden Research Consultants

Oklahoma City, Oklahoma, United States

Location

Pahl Brain Associates

Oklahoma City, Oklahoma, United States

Location

Oregon Center for Clinical Investigators, Inc.

Eugene, Oregon, United States

Location

PRO Research

Eugene, Oregon, United States

Location

Attn: Valerie MacDonald

Portland, Oregon, United States

Location

The Clinical Trial Center, LLC

Jenkintown, Pennsylvania, United States

Location

Crosswords Counseling and Consulting Associates

Moon Township, Pennsylvania, United States

Location

Pearl Clinical Research, Inc.

Norristown, Pennsylvania, United States

Location

Rhode Island Mood and Memory Research Institute

East Providence, Rhode Island, United States

Location

Butler Hospital Dept. of Neurology

Providence, Rhode Island, United States

Location

Medical Univ. of South Carolina, Alzheimer's Research

North Charleston, South Carolina, United States

Location

Psychiatric Consultants

Nashville, Tennessee, United States

Location

Baylor College of Medicine VA Medical Center

Houston, Texas, United States

Location

University of Texas Medical Science Institute

Houston, Texas, United States

Location

Caprock Clinical Trials Center

Lubbock, Texas, United States

Location

Integra Clinical Research

San Antonio, Texas, United States

Location

Grayline Clinical Drug Trials

Wichita Falls, Texas, United States

Location

The Memory Clinic/Southwestern Vermont Medical Center

Bennington, Vermont, United States

Location

UVA Dept. of Neurology

Charlottesville, Virginia, United States

Location

Independent Psychiatric Consultants

Waukesha, Wisconsin, United States

Location

Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Location

Boehringer Ingelheim Investigational Site

Winnipeg, Manitoba, Canada

Location

Infectious Disease

Moncton, New Brunswick, Canada

Location

Boehringer Ingelheim Investigational Site

London, Ontario, Canada

Location

Clinical Research Consultant Group

Beaconsfield, Quebec, Canada

Location

Boehringer Ingelheim Investigational Site

Greenfield Park, Quebec, Canada

Location

Pasqua Hospital

Regina, Saskatchewan, Canada

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Tesofensine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Boehringer Ingelheim Study Coordinator

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 12, 2005
• Study Start: February 1, 2003
• Primary Completion: March 1, 2005
• Last Updated: October 29, 2013

Record last verified: 2013-10

Locations

CA (7); US (80)