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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.
 
ClinicalTrials.gov Identifier: NCT00040443
Recruitment Status : Completed
First Posted : June 28, 2002
Results First Posted : July 23, 2018
Last Update Posted : July 23, 2018
Sponsor:
Information provided by (Responsible Party):
RespireRx

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 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
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
Actual Primary Completion Date : August 2003
Actual Study Completion Date : June 2004

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CX516
CX516 - 900 mg
Drug: CX516
Placebo Comparator: Placebo
Placebo
Drug: Placebo



Primary Outcome Measures :
  1. 15-Item Word List Delayed Recall [ Time Frame: 28 Days ]

    The 15-Item Word List delayed recall score is used as a clinical measure of episodic memory, and was the primary outcome variable for this study. Episodic memory of the type addressed by delayed recall of lists and stories (i.e., in the WMS-R logical memory tests and 15-item World List recall tests) is among the earliest deficits during aging and MCI compared to other aspects of cognition (attention, reaction time, language, etc). It was decided to use the 15-item Word List delayed recall test as the primary outcome measure due to its sensitivity in the assessment of MCI.

    The possible score range for the 15-item Word List Delayed Recall test is 0 to 15. A clinical improvement of MCI or dementia would be characterized by an increase in the score due to an increase in the number of words recalled.




Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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 ClinicalTrials.gov identifier (NCT number): NCT00040443


Locations
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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

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Responsible Party: RespireRx
ClinicalTrials.gov Identifier: NCT00040443    
Other Study ID Numbers: CORX-CX516-012.1
First Posted: June 28, 2002    Key Record Dates
Results First Posted: July 23, 2018
Last Update Posted: July 23, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by RespireRx:
Mild Cognitive Impairment
Memory Loss
Alzheimer's Disease
Brain Aging
Ampalex®
CX516
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders