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

This study has been completed.
Sponsor:
Information provided by:
Cortex Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00040443
First received: June 26, 2002
Last updated: June 23, 2005
Last verified: February 2005
  Purpose

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 Intervention Phase
Mild Cognitive Impairment
Drug: CX516 (Ampalex®)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by Cortex Pharmaceuticals:

Estimated Enrollment: 160
Study Start Date: April 2002
Estimated Study Completion Date: March 2003
  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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 ClinicalTrials.gov identifier: NCT00040443

Locations
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
Cortex Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00040443     History of Changes
Other Study ID Numbers: CORX-CX516-012.1
Study First Received: June 26, 2002
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by Cortex Pharmaceuticals:
Mild Cognitive Impairment
Memory Loss
Alzheimer's Disease
Brain Aging
Ampalex®
CX516

Additional relevant MeSH terms:
Mild Cognitive Impairment
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 22, 2014