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Alzheimer DiseasePhase 2NCT00153010

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

A Phase 2 study testing NS 2330 (Tesofensine) in people with Alzheimer Disease, run by Boehringer Ingelheim at 87 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 85 years
Conditions the study is for
Alzheimer Disease
What is being tested?
NS 2330 (Tesofensine)
How many people
430 participants
Where
87 sitesin 2 countries
Study dates
Feb 2003to Mar 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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).
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.
Show all 29Show fewer
  • 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.
  • 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.
  • HIV positive.
  • Presence of Hepatitis C antibody.
  • Planned elective surgery requiring general anesthesia or hospitalization for more than 1 day during the study period.
  • Previous participation in any NS 2330 study.
  • Use of any investigational drug or procedure within 30 days before randomization.
  • 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.
  • Treatment with donepezil, galantamine, rivastigmine, or tacrine, is prohibited within 6 weeks before randomization.
  • 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.
  • Treatment with antipsychotics/neuroleptics is prohibited for 8 weeks prior to randomisation (see listing Appendix II).
  • Treatment with monoamine oxidase inhibitors is prohibited for 8 weeks prior to randomization.
  • Treatment with selective serotonin reuptake inhibitors is prohibited for 6 weeks prior to randomization.
  • Tricyclic antidepressants and antihistamines are prohibited for 4 weeks prior to randomization.

Trial locations and contacts

87 sites in 2 countries.

87 sites in 2 countries

United States80 sites

  • Neurological Associates of Albany

    Albany, New York

  • Upstate Clinical Research

    Albany, New York

  • Albuquerque Neuroscience

    Albuquerque, New Mexico

  • Dent Neurologic Institute

    Amherst, New York

  • Atlanta Center for Medical Research

    Atlanta, Georgia

  • North Coast Clinical Trials, Inc.

    Beachwood, Ohio

  • The Memory Clinic/Southwestern Vermont Medical Center

    Bennington, Vermont

  • Boehringer Ingelheim Investigational Site

    Berkeley, California

  • Baumel-Eisner Neuromedical Institute

    Boca Raton, Florida

  • UVA Dept. of Neurology

    Charlottesville, Virginia

  • Peryam and Kroll Healthcare Research

    Chicago, Illinois

  • Boehringer Ingelheim Investigational Site

    Cincinnati, Ohio

  • University of Missouri

    Columbia, Missouri

  • California Clinical Trials Medical Group

    Culver City, California

  • Associated Neurologists PC - Danbury

    Danbury, Connecticut

  • Midwest Clinical Research Center

    Dayton, Ohio

  • Duke University Medical Center

    Durham, North Carolina

  • Rhode Island Mood and Memory Research Institute

    East Providence, Rhode Island

  • Oregon Center for Clinical Investigators, Inc.

    Eugene, Oregon

  • PRO Research

    Eugene, Oregon

  • Hartford Research Group

    Florence, Kentucky

  • Baumel-Eisner Neuromedical Institute

    Fort Lauderdale, Florida

  • Neurologic Consulting/PA

    Fort Lauderdale, Florida

  • Clinical Physiology Associates Study Center

    Fort Meyers, Florida

  • Margolin Brain Institute

    Fresno, California

  • Care@ Granada Hills Community Hospital

    Granada Hills, California

  • Center for Geriatric & Adult Psychiatry

    Hamden, Connecticut

  • Berma Research Group

    Hialeah, Florida

  • Sunrise Clinical Research

    Hollywood, Florida

  • Baylor College of Medicine VA Medical Center

    Houston, Texas

  • University of Texas Medical Science Institute

    Houston, Texas

  • Agewell, Ltd.

    Indianapolis, Indiana

  • University of Iowa College of Medicine

    Iowa City, Iowa

  • The Clinical Trial Center, LLC

    Jenkintown, Pennsylvania

  • Optimum Health Services

    La Mesa, California

  • LaGrange Hospital

    LaGrange, Illinois

  • University of Nevada School of Medicine

    Las Vegas, Nevada

  • Associates in Neurology-Research

    Lexington, Kentucky

  • Triangle Medical Research

    Lexington Road, North Carolina

  • Caprock Clinical Trials Center

    Lubbock, Texas

  • Pivotal Research Center

    Mesa, Arizona

  • Baumel-Eisner Neuromedical Institute

    Miami, Florida

  • Miami Jewish Home and Hospital for the Aged

    Miami, Florida

  • Crosswords Counseling and Consulting Associates

    Moon Township, Pennsylvania

  • Psychiatric Consultants

    Nashville, Tennessee

  • Louisiana State University Medical Center

    New Orleans, Louisiana

  • Eastside Comprehensive Medical Services

    New York, New York

  • Social Psychiatry Research Institute

    New York, New York

  • The Jewish Home and Hospital

    New York, New York

  • Pearl Clinical Research, Inc.

    Norristown, Pennsylvania

  • Medical Univ. of South Carolina, Alzheimer's Research

    North Charleston, South Carolina

  • Segal Institute for Clinical Research

    North Miami, Florida

  • Magnolia Research Group

    Ocala, Florida

  • Optimum Health Services

    Oceanside, California

  • Linden Research Consultants

    Oklahoma City, Oklahoma

  • Pahl Brain Associates

    Oklahoma City, Oklahoma

  • Pivotal Research Center

    Peoria, Arizona

  • Xenoscience

    Phoenix, Arizona

  • Memory Disorder Clinic

    Pompano Beach, Florida

  • Attn: Valerie MacDonald

    Portland, Oregon

  • Butler Hospital Dept. of Neurology

    Providence, Rhode Island

  • Southwest Institute for Clinical Research

    Rancho Mirage, California

  • Saginaw Cooperative Hosp. Inc./ Internal medicine

    Saginaw, Michigan

  • Integra Clinical Research

    San Antonio, Texas

  • Health Quest Clinical Trials

    San Diego, California

  • Institute on Aging Research Center

    San Francisco, California

  • Attn: M. Lannom, RN, MS

    Sharon, Massachusetts

  • Future Care Studies

    Springfield, Massachusetts

  • St. Louis University

    St Louis, Missouri

  • Boehringer Ingelheim Investigational Site

    Tampa, Florida

  • USF Suncoast Gerontology Center

    Tampa, Florida

  • Neurology Center of Ohio

    Toledo, Ohio

  • Atlantic Coast Research

    Toms River, New Jersey

  • Torrance Clinical Research

    Torrance, California

  • North Michigan Neurology

    Traverse City, Michigan

  • Independent Psychiatric Consultants

    Waukesha, Wisconsin

  • Palm Beach Neurology/Premier Research Institute

    West Palm Beach, Florida

  • Grayline Clinical Drug Trials

    Wichita Falls, Texas

  • Neurology Associates PA

    Wilmington, Delaware

  • Boehringer Ingelheim Investigational Site

    Winston-Salem, North Carolina

Other trials in United States

Canada7 sites

  • Clinical Research Consultant Group

    Beaconsfield, Quebec

  • Boehringer Ingelheim Investigational Site

    Greenfield Park, Quebec

  • Boehringer Ingelheim Investigational Site

    London, Ontario

  • Infectious Disease

    Moncton, New Brunswick

  • Pasqua Hospital

    Regina, Saskatchewan

  • Boehringer Ingelheim Investigational Site

    Vancouver, British Columbia

  • Boehringer Ingelheim Investigational Site

    Winnipeg, Manitoba

Other trials in Canada

About this study

Official title: 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.

Being tested
NS 2330 (Tesofensine)
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NS 2330 (Tesofensine)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: week 0, 4, 9, 14 and 20

Secondary outcomes (13)

  1. Alzheimer's Disease Cooperative Study-Clinical Global Impression of Change

    Measured: weeks 0 and 14

  2. Alzheimer's Disease Cooperative Study-Activities of Daily Living

    Measured: weeks 0, 4, and 14

  3. Neuropsychiatric Inventory

    Measured: weeks 0, 4, and 14

  4. Mini-Mental State Examination

    Measured: weeks 0 and 14

  5. ADAS-Cog Extension

    Measured: weeks 0, 4, 9, 14 and 20

  6. ADAS-Cog total score including Extension

    Measured: weeks 0, 4, and 14

  7. types and frequencies of adverse events

    Measured: 20 weeks

  8. proportion of patients discontinued from the trial because of adverse events

    Measured: 20 weeks

  9. changes from baseline in vital signs

    Measured: 20 weeks

  10. changes from baseline in laboratory measurements

    Measured: 20 weeks

  11. changes from baseline in ECG readings

    Measured: 20 weeks

  12. comparison of study groups for drug plasma concentrations

    Measured: weeks 0, 4, 9, 14 and 20

  13. population PK parameters

    Measured: Weeks 0, 4, 9, 14 and 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2005 (estimated)
  2. Study startFeb 2003
  3. Primary completionMar 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
430 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00153010
Sponsor's protocol ID
1198.52
Status last verified
Oct 2013
First submitted
9 Sep 2005
Last updated
29 Oct 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NS 2330 (Tesofensine) in people with Alzheimer Disease, run by Boehringer Ingelheim at 87 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 87 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) (time frame: week 0, 4, 9, 14 and 20). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00153010.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2013.

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