Efficacy And Safety Of CX516 In Elderly Participants With Mild Cognitive Impairment.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00040443
Recruitment Status : Completed
First Posted : June 28, 2002
Last Update Posted : June 24, 2005
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Brief Summary:
Glutamate is fundamentally involved in learning and memory. Memory loss associated with mild cognitive impairment may be due to loss of glutamate receptors in the aging brain. There is evidence CX516 enhances brain activity by specifically targeting remaining glutamate receptors in the affected portions of the brain. This study will test the safety and efficacy of CX516 in the symptomatic treatment of participants with mild cognitive impairment.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Drug: CX516 (Ampalex®) Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Efficacy And Safety Of CX516 (900 Mg t.i.d.) In Elderly Participants With Mild Cognitive Impairment. A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group 4-Week Study.
Study Start Date : April 2002
Study Completion Date : March 2003

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria

  • Clinical diagnosis of mild cognitive impairment
  • Good general health with no additional diseases that would interfere with the study.

Exclusion criteria

  • Any significant neurologic disease (other than suspected incipient Alzheimer's disease), such as Parkinson's disease, stroke, TIA's, multi-infarct dementia, Huntington's disease, head trauma, chronic CNS infection.
  • History of major depression or another major psychiatric disorder within the past 6 months.
  • History of schizophrenia, mania or recurrent psychotic episodes.
  • History of alcohol or DSM IV-diagnosed substance abuse or dependence disorder within the past year.
  • History of blackout, epilepsy or seizures, or an abnormal EEG as judged by the Investigator and considering the age of the participant.
  • Any clinically significant hepatic, renal, cardiovascular, pulmonary, gastrointestinal or hematological illness or unstable medical condition which could interfere with drug safety, or absorption, distribution, metabolism and excretion, or lead to difficulty complying with the protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00040443

United States, Arizona
Pivotal Research Centers
Peoria, Arizona, United States, 85381
United States, California
University of California Irvine
Irvine, California, United States, 92697
University of California at Los Angeles
Los Angeles, California, United States, 90095
University of California, San Diego
San Diego, California, United States, 92093
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
United States, Florida
Sun Coast Gerontology Center, University of South Florida
Tampa, Florida, United States, 33617
United States, Iowa
Mercy Mayo Clinic
Des Moines, Iowa, United States, 50314
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
RespireRx Identifier: NCT00040443     History of Changes
Other Study ID Numbers: CORX-CX516-012.1
First Posted: June 28, 2002    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: February 2005

Keywords provided by RespireRx:
Mild Cognitive Impairment
Memory Loss
Alzheimer's Disease
Brain Aging

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders