Namenda to Prevent Post-Operative Delirium

This study has been terminated.
Forest Laboratories
Information provided by:
University of Rochester Identifier:
First received: March 14, 2006
Last updated: June 2, 2015
Last verified: December 2009

Post Operative Delirium is a common and serious risk of surgery. Delirium, when it occurs is associated with an increased risk of mortality, increase length of stay, and more adverse outcomes in general, including increased risk of higher level of care required at discharge.

Namenda, which is currently approved for moderate or severe Alzheimer's disease has a unique mechanism of action than other drugs for this condition. It may have the ability to protect the brain from more severe consequences of hypoxia, or hypoglycemia. Hence it is being looked at in this study to see if it can reduce the incidence and/or severity of delirium post-operatively.

Condition Intervention Phase
Post-Operative States
Drug: Namenda
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Namenda as Prevention for Post-Operative Delirium

Resource links provided by NLM:

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Incidence and severity of delirium measured by Delirium Rating Scale-Revised-98, MMSE. Confusion Assessment Method, Clock Drawing Tests (CLOX), DSM-IV-TR criteria for Delirium.

Secondary Outcome Measures:
  • Length and cost of stay, disposition, level of care required post hosptialization, hospitalization satisfaction, number of consultants involved, total costs of care.

Estimated Enrollment: 30
Study Start Date: March 2006
Estimated Study Completion Date: September 2006
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Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Medically stable
  • 50 years of age or older
  • having elective joint replacement surgery or other orthopedic procedures that are major surgery and require general anesthesia.

Exclusion Criteria:

  • Alcohol or sedative hypnotic abuse or dependence
  • Pregnancy
  • Dementia or MR/DD patients if they do not have sufficient capacity to understand the consent
  • renal impairment or a creatinine of 1.4 or higher
  • currently taking cholinesterase inhibitors.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00303433

United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Forest Laboratories
Principal Investigator: Michael R Privitera, MD University of Rochester
  More Information

Foreman MD. Prevention and Treatment Strategies for Delirium. Primary Psychiatry 11(11): 52-58, 2004.
Potkin et al Abstract LBS.003 American Academy of Neurology 56th annual meeting April 24-May 1 2004, San Francisco California.
Diagnostic and Statistical Manual of Mental Disorders, Forth Edition, Text Revision. Washington D.C., American Psychiatric Association, 2000.
Cohen J. Statistical Power Analysis for the Behavioral Sciences, 2nd ed. Lawrence Erlbaum Associates, New Jersey. Identifier: NCT00303433     History of Changes
Obsolete Identifiers: NCT00303095
Other Study ID Numbers: RSRB-00012460, NAM-MD-35
Study First Received: March 14, 2006
Last Updated: June 2, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Rochester:
Post-Operative tates

Additional relevant MeSH terms:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on November 25, 2015