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

Mild Cognitive Impairment Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00040443
• Other study ID #: CORX-CX516-012.1
• Status: Completed
• Phase: Phase 2
• Start date: April 2002
• Est. completion date: June 2004

Study information

• Verified date: October 2017
• Source: RespireRx
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: June 2004
• Est. primary completion date: August 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Drug:
• CX516

• Placebo

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
RespireRx

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	15-Item Word List Delayed Recall	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.	28 Days