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

Last updated: October 9, 2017
Sponsor: RespireRx
Overall Status: Completed

Phase

2

Condition

Dementia

Alzheimer's Disease

Mild Cognitive Impairment

Treatment

N/A

Clinical Study ID

NCT00040443
CORX-CX516-012.1
  • Ages 55-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 175
Study Start date:
April 01, 2002
Estimated Completion Date:
June 30, 2004

Connect with a study center

  • Pivotal Research Centers

    Peoria, Arizona 85381
    United States

    Site Not Available

  • University of California Irvine

    Irvine, California 92697
    United States

    Site Not Available

  • University of California at Los Angeles

    Los Angeles, California 90095
    United States

    Site Not Available

  • University of California, San Diego

    San Diego, California 92093
    United States

    Site Not Available

  • Yale University School of Medicine

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Sun Coast Gerontology Center, University of South Florida

    Tampa, Florida 33617
    United States

    Site Not Available

  • Mercy Mayo Clinic

    Des Moines, Iowa 50314
    United States

    Site Not Available

  • University of Pittsburgh

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

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