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

October 28, 2013 updated by: Boehringer Ingelheim

A Phase II Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled, Multicenter, Safety and Efficacy Evaluation of Three Doses of NS 2330 in Patients With Mild to Moderate Dementia of the Alzheimer's Type

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

430

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Boehringer Ingelheim Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • Boehringer Ingelheim Investigational Site
    • New Brunswick
      • Moncton, New Brunswick, Canada
        • Infectious Disease
    • Ontario
      • London, Ontario, Canada
        • Boehringer Ingelheim Investigational Site
    • Quebec
      • Beaconsfield, Quebec, Canada
        • Clinical Research Consultant Group
      • Greenfield Park, Quebec, Canada
        • Boehringer Ingelheim Investigational Site
    • Saskatchewan
      • Regina, Saskatchewan, Canada
        • Pasqua Hospital
  • United States
    • Arizona
      • Mesa, Arizona, United States
        • Pivotal Research Center
      • Peoria, Arizona, United States
        • Pivotal Research Center
      • Phoenix, Arizona, United States
        • Xenoscience
    • California
      • Berkeley, California, United States
        • Boehringer Ingelheim Investigational Site
      • Culver City, California, United States
        • California Clinical Trials Medical Group
      • Fresno, California, United States
        • Margolin Brain Institute
      • Granada Hills, California, United States
        • Care@ Granada Hills Community Hospital
      • LaMesa, California, United States
        • Optimum Health Services
      • Oceanside, California, United States
        • Optimum Health Services
      • Rancho Mirage, California, United States
        • Southwest Institute for Clinical Research
      • San Diego, California, United States
        • Health Quest Clinical Trials
      • San Francisco, California, United States
        • Institute on Aging Research Center
      • Torrance, California, United States
        • Torrance Clinical Research
    • Connecticut
      • Danbury, Connecticut, United States
        • Associated Neurologists PC - Danbury
      • Hamden, Connecticut, United States
        • Center for Geriatric & Adult Psychiatry
    • Delaware
      • Wilmington, Delaware, United States
        • Neurology Associates PA
    • Florida
      • Boca Raton, Florida, United States
        • Baumel-Eisner Neuromedical Institute
      • Fort Lauderdale, Florida, United States
        • Baumel-Eisner Neuromedical Institute
      • Fort Lauderdale, Florida, United States
        • Neurologic Consulting/PA
      • Fort Meyers, Florida, United States
        • Clinical Physiology Associates Study Center
      • Hialeah, Florida, United States
        • Berma Research Group
      • Hollywood, Florida, United States
        • Sunrise Clinical Research
      • Miami, Florida, United States
        • Baumel-Eisner Neuromedical Institute
      • Miami, Florida, United States
        • Miami Jewish Home and Hospital for the Aged
      • N. Miami, Florida, United States
        • Segal Institute for Clinical Research
      • Ocala, Florida, United States
        • Magnolia Research Group
      • Pompano Beach, Florida, United States
        • Memory Disorder Clinic
      • Tampa, Florida, United States
        • Boehringer Ingelheim Investigational Site
      • Tampa, Florida, United States
        • USF Suncoast Gerontology Center
      • W. Palm Beach, Florida, United States
        • Palm Beach Neurology/Premier Research Institute
    • Georgia
      • Atlanta, Georgia, United States
        • Atlanta Center for Medical Research
    • Illinois
      • Chicago, Illinois, United States
        • Peryam and Kroll Healthcare Research
      • LaGrange, Illinois, United States
        • LaGrange Hospital
    • Indiana
      • Indianapolis, Indiana, United States
        • Agewell, Ltd.
    • Iowa
      • Iowa City, Iowa, United States
        • University of Iowa College of Medicine
    • Kentucky
      • Florence, Kentucky, United States
        • Hartford Research Group
      • Lexington, Kentucky, United States
        • Associates in Neurology-Research
    • Louisiana
      • New Orleans, Louisiana, United States
        • Louisiana State University Medical Center
    • Massachusetts
      • Sharon, Massachusetts, United States
        • Attn: M. Lannom, RN, MS
      • Springfield, Massachusetts, United States
        • Future Care Studies
    • Michigan
      • Saginaw, Michigan, United States
        • Saginaw Cooperative Hosp. Inc./ Internal medicine
      • Traverse City, Michigan, United States
        • North Michigan Neurology
    • Missouri
      • Columbia, Missouri, United States
        • University of Missouri
      • St. Louis, Missouri, United States
        • St. Louis University
    • Nevada
      • Las Vegas, Nevada, United States
        • University of Nevada School of Medicine
    • New Jersey
      • Tom's River, New Jersey, United States
        • Atlantic Coast Research
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Albuquerque Neuroscience
    • New York
      • Albany, New York, United States
        • Neurological Associates of Albany
      • Albany, New York, United States
        • Upstate Clinical Research
      • Amherst, New York, United States
        • Dent Neurologic Institute
      • New York, New York, United States
        • Eastside Comprehensive Medical Services
      • New York, New York, United States
        • Social Psychiatry Research Institute
      • New York, New York, United States
        • The Jewish Home and Hospital
    • North Carolina
      • Durham, North Carolina, United States
        • Duke University Medical Center
      • Lexington Road, North Carolina, United States
        • Triangle Medical Research
      • Winston-Salem, North Carolina, United States
        • Boehringer Ingelheim Investigational Site
    • Ohio
      • Beachwood, Ohio, United States
        • North Coast Clinical Trials, Inc.
      • Cincinnati, Ohio, United States
        • Boehringer Ingelheim Investigational Site
      • Dayton, Ohio, United States
        • Midwest Clinical Research Center
      • Toledo, Ohio, United States
        • Neurology Center Of Ohio
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Linden Research Consultants
      • Oklahoma City, Oklahoma, United States
        • Pahl Brain Associates
    • Oregon
      • Eugene, Oregon, United States
        • Oregon Center for Clinical Investigators, Inc.
      • Eugene, Oregon, United States
        • PRO Research
      • Portland, Oregon, United States
        • Attn: Valerie MacDonald
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States
        • The Clinical Trial Center, LLC
      • Moon Township, Pennsylvania, United States
        • Crosswords Counseling and Consulting Associates
      • Norristown, Pennsylvania, United States
        • Pearl Clinical Research, Inc.
    • Rhode Island
      • E. Providence, Rhode Island, United States
        • Rhode Island mood and memory research institute
      • Providence, Rhode Island, United States
        • Butler Hospital Dept. of Neurology
    • South Carolina
      • N Charleston., South Carolina, United States
        • Medical Univ. of South Carolina, Alzheimer's Research
    • Tennessee
      • Nashville, Tennessee, United States
        • Psychiatric Consultants
    • Texas
      • Houston, Texas, United States
        • Baylor College of Medicine VA Medical Center
      • Houston, Texas, United States
        • University of Texas Medical Science Institute
      • Lubbock, Texas, United States
        • Caprock Clinical Trials Center
      • San Antonio, Texas, United States
        • Integra Clinical Research
      • Wichita Falls, Texas, United States
        • Grayline Clinical Drug Trials
    • Vermont
      • Bennington, Vermont, United States
        • The Memory Clinic/Southwestern Vermont Medical Center
    • Virginia
      • Charlottesville, Virginia, United States
        • UVA Dept. of Neurology
    • Wisconsin
      • Waukesha, Wisconsin, United States
        • Independent Psychiatric Consultants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

INCLUSION CRITERIA

Patients may be included in this study if they meet all of the following criteria:

  1. 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.
  2. 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
  3. 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.
  4. Modified Hachinski Scale10 score no greater than 4.
  5. Central nervous system imaging (CT or MRI scan of brain) compatible with Dementia of the Alzheimer's Type within the past year (also see exclusion criteria).
  6. 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).
  7. Patients and/or a legal representative and their caregivers must have given informed consent. The legal representative and caregiver may be the same person.
  8. 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.

EXCLUSION CRITERIA

Patients must be excluded from this study if they meet any of the following criteria:

  1. Secondary disorders inducing dementia such as neurosyphilis, craniocerebral trauma (CT/MRI), hyperthyroidism, or folic acid deficiency.
  2. History of malignancy within 3 years, except for basal cell carcinoma.

  3. 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.
    • Hematological disease (regardless of cause) such as refractory anemia or refractory myelosuppression.
    • Organ system diseases which, in the opinion of the investigator, would impact on the primary and secondary endpoints of the trial such as dehydration (hematocrit >48%) or hypothyroidism.
  4. Significant history of drug dependence or abuse (including alcohol, as defined in DSM IV or in the opinion of the investigator) within two years, or a positive urine drug screen for cocaine, heroin, or marijuana.
  5. HIV positive.
  6. Presence of Hepatitis C antibody.
  7. Planned elective surgery requiring general anesthesia or hospitalization for more than 1 day during the study period.
  8. Previous participation in any NS 2330 study.
  9. Use of any investigational drug or procedure within 30 days before randomization.

  10. Use of any drug within 14 days prior to randomization unless:

    • the dose of the drug and the condition being treated have been stable for at least 30 days and are expected to remain stable during the study
    • neither the drug nor the condition being treated is expected to interfere with the study endpoints.
  11. Treatment with donepezil, galantamine, rivastigmine, or tacrine, is prohibited within 6 weeks before randomization.
  12. Treatment with drugs that inhibit CYP 450 3A4 (see Appendix II for a list of relevant drugs.) If they are needed under emergency conditions, the patient should discontinue the trial.
  13. Treatment with antipsychotics/neuroleptics is prohibited for 8 weeks prior to randomisation (see listing Appendix II).
  14. Treatment with monoamine oxidase inhibitors is prohibited for 8 weeks prior to randomization.
  15. Treatment with selective serotonin reuptake inhibitors is prohibited for 6 weeks prior to randomization.
  16. Tricyclic antidepressants and antihistamines are prohibited for 4 weeks prior to randomization.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
Time Frame: week 0, 4, 9, 14 and 20
week 0, 4, 9, 14 and 20

Secondary Outcome Measures

Outcome Measure
Time Frame
Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change
Time Frame: weeks 0 and 14
weeks 0 and 14
Alzheimer's Disease Cooperative Study-Activities of Daily Living
Time Frame: weeks 0, 4, and 14
weeks 0, 4, and 14
Neuropsychiatric Inventory
Time Frame: weeks 0, 4, and 14
weeks 0, 4, and 14
Mini-Mental State Examination
Time Frame: weeks 0 and 14
weeks 0 and 14
ADAS-Cog Extension
Time Frame: weeks 0, 4, 9, 14 and 20
weeks 0, 4, 9, 14 and 20
ADAS-Cog total score including Extension
Time Frame: weeks 0, 4, and 14
weeks 0, 4, and 14
types and frequencies of adverse events
Time Frame: 20 weeks
20 weeks
proportion of patients discontinued from the trial because of adverse events
Time Frame: 20 weeks
20 weeks
changes from baseline in vital signs
Time Frame: 20 weeks
20 weeks
changes from baseline in laboratory measurements
Time Frame: 20 weeks
20 weeks
changes from baseline in ECG readings
Time Frame: 20 weeks
20 weeks
comparison of study groups for drug plasma concentrations
Time Frame: weeks 0, 4, 9, 14 and 20
weeks 0, 4, 9, 14 and 20
population PK parameters
Time Frame: Weeks 0, 4, 9, 14 and 20
Weeks 0, 4, 9, 14 and 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

March 1, 2005

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

October 29, 2013

Last Update Submitted That Met QC Criteria

October 28, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1198.52

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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