Expired Study
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Tampa, Florida 33617


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.


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.


Study is Available At:


Original ID:

CORX-CX516-012.1


NCT ID:

NCT00040443


Secondary ID:


Study Acronym:


Brief Title:

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


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.


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


Minimum Age:

55 Years


Maximum Age:

85 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

RespireRx


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

175


Enrollment Type:

Actual


Study Dates

Start Date:April 2002
Completion Date:June 2004
Completion Type:Actual
Primary Completion Date:August 2003
Primary Completion Type:Actual
Verification Date:October 2017
Last Changed Date:October 9, 2017
First Received Date:June 26, 2002
First Results Date:July 27, 2016

Study Outcomes

Outcome Type:Primary Outcome
Measure:15-Item Word List Delayed Recall
Time Frame:28 Days
Safety Issues:False
Description: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 memo

Study Interventions

Intervention Type:Drug
Name:CX516
Arm Name:CX516
Intervention Type:Drug
Name:Placebo
Arm Name:Placebo

Study Arms

Study Arm Type:Experimental
Arm Name:CX516
Description:CX516 - 900 mg
Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Placebo

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:RespireRx

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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