Efficacy And Safety Of CX516 In Elderly Participants With Mild Cognitive Impairment.
This study has been completed.
Sponsor:
Cortex Pharmaceuticals
Information provided by:
Cortex Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00040443
First received: June 26, 2002
Last updated: June 23, 2005
Last verified: February 2005
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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:
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
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:
|
Cognition Disorders Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 21, 2013