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

Completed · Phase 2 · Has a placebo group

Conditions studied: Mild Cognitive Impairment

In brief

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.

Key facts

Study ID

NCT00040443

Run by

RespireRx

People needed

175

Starts

2002-04-01

Expected to finish

2004-06-01

Last updated by the study team

2018-07-23

Who can join

Age: 55 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Pivotal Research Centers — Peoria, Arizona, United States
• University of California Irvine — Irvine, California, United States
• University of California at Los Angeles — Los Angeles, California, United States
• University of California, San Diego — San Diego, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Sun Coast Gerontology Center, University of South Florida — Tampa, Florida, United States
• Mercy Mayo Clinic — Des Moines, Iowa, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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