An Evaluation of Three Doses of NS 2330 in Patients With Mild to Moderate Dementia of the Alzheimer's Type
NCT ID: NCT00153010
Last Updated: 2013-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
430 participants
INTERVENTIONAL
2003-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
NS 2330 (Tesofensine)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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.
Exclusion Criteria
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.
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.
40 Years
85 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boehringer Ingelheim
INDUSTRY
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Boehringer Ingelheim Study Coordinator
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pivotal Research Center
Mesa, Arizona, United States
Pivotal Research Center
Peoria, Arizona, United States
Xenoscience
Phoenix, Arizona, United States
Boehringer Ingelheim Investigational Site
Berkeley, California, United States
California Clinical Trials Medical Group
Culver City, California, United States
Margolin Brain Institute
Fresno, California, United States
Care@ Granada Hills Community Hospital
Granada Hills, California, United States
Optimum Health Services
La Mesa, California, United States
Optimum Health Services
Oceanside, California, United States
Southwest Institute for Clinical Research
Rancho Mirage, California, United States
Health Quest Clinical Trials
San Diego, California, United States
Institute on Aging Research Center
San Francisco, California, United States
Torrance Clinical Research
Torrance, California, United States
Associated Neurologists PC - Danbury
Danbury, Connecticut, United States
Center for Geriatric & Adult Psychiatry
Hamden, Connecticut, United States
Neurology Associates PA
Wilmington, Delaware, United States
Baumel-Eisner Neuromedical Institute
Boca Raton, Florida, United States
Baumel-Eisner Neuromedical Institute
Fort Lauderdale, Florida, United States
Neurologic Consulting/PA
Fort Lauderdale, Florida, United States
Clinical Physiology Associates Study Center
Fort Meyers, Florida, United States
Berma Research Group
Hialeah, Florida, United States
Sunrise Clinical Research
Hollywood, Florida, United States
Baumel-Eisner Neuromedical Institute
Miami, Florida, United States
Miami Jewish Home and Hospital for the Aged
Miami, Florida, United States
Segal Institute for Clinical Research
North Miami, Florida, United States
Magnolia Research Group
Ocala, Florida, United States
Memory Disorder Clinic
Pompano Beach, Florida, United States
Boehringer Ingelheim Investigational Site
Tampa, Florida, United States
USF Suncoast Gerontology Center
Tampa, Florida, United States
Palm Beach Neurology/Premier Research Institute
West Palm Beach, Florida, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Peryam and Kroll Healthcare Research
Chicago, Illinois, United States
LaGrange Hospital
LaGrange, Illinois, United States
Agewell, Ltd.
Indianapolis, Indiana, United States
University of Iowa College of Medicine
Iowa City, Iowa, United States
Hartford Research Group
Florence, Kentucky, United States
Associates in Neurology-Research
Lexington, Kentucky, United States
Louisiana State University Medical Center
New Orleans, Louisiana, 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
North Michigan Neurology
Traverse City, Michigan, United States
University of Missouri
Columbia, Missouri, United States
St. Louis University
St Louis, Missouri, United States
University of Nevada School of Medicine
Las Vegas, Nevada, United States
Atlantic Coast Research
Toms River, New Jersey, United States
Albuquerque Neuroscience
Albuquerque, New Mexico, United States
Neurological Associates of Albany
Albany, New York, United States
Upstate Clinical Research
Albany, New York, United States
Dent Neurologic Institute
Amherst, 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
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Triangle Medical Research
Lexington Road, North Carolina, United States
Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina, United States
North Coast Clinical Trials, Inc.
Beachwood, Ohio, United States
Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
Neurology Center of Ohio
Toledo, Ohio, United States
Linden Research Consultants
Oklahoma City, Oklahoma, United States
Pahl Brain Associates
Oklahoma City, Oklahoma, United States
Oregon Center for Clinical Investigators, Inc.
Eugene, Oregon, United States
PRO Research
Eugene, Oregon, United States
Attn: Valerie MacDonald
Portland, Oregon, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States
Crosswords Counseling and Consulting Associates
Moon Township, Pennsylvania, United States
Pearl Clinical Research, Inc.
Norristown, Pennsylvania, United States
Rhode Island Mood and Memory Research Institute
East Providence, Rhode Island, United States
Butler Hospital Dept. of Neurology
Providence, Rhode Island, United States
Medical Univ. of South Carolina, Alzheimer's Research
North Charleston, South Carolina, United States
Psychiatric Consultants
Nashville, Tennessee, United States
Baylor College of Medicine VA Medical Center
Houston, Texas, United States
University of Texas Medical Science Institute
Houston, Texas, United States
Caprock Clinical Trials Center
Lubbock, Texas, United States
Integra Clinical Research
San Antonio, Texas, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States
The Memory Clinic/Southwestern Vermont Medical Center
Bennington, Vermont, United States
UVA Dept. of Neurology
Charlottesville, Virginia, United States
Independent Psychiatric Consultants
Waukesha, Wisconsin, United States
Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
Boehringer Ingelheim Investigational Site
Winnipeg, Manitoba, Canada
Infectious Disease
Moncton, New Brunswick, Canada
Boehringer Ingelheim Investigational Site
London, Ontario, Canada
Clinical Research Consultant Group
Beaconsfield, Quebec, Canada
Boehringer Ingelheim Investigational Site
Greenfield Park, Quebec, Canada
Pasqua Hospital
Regina, Saskatchewan, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1198.52
Identifier Type: -
Identifier Source: org_study_id
NCT00055406
Identifier Type: -
Identifier Source: nct_alias