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

Phase 2

Completed

• Conditions: Mild Cognitive Impairment
• Interventions: Drug: Placebo; Drug: CX516

• Registration Number: NCT00040443
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Study First Submitted: 2002-06-26
• Study First Submitted QC: 2002-06-27
• Study First Posted: 2002-06-28
• Primary Completion: 2003-08
• Study Completion: 2004-06
• Results First Submitted: 2016-07-27
• Status Verified: 2017-10
• Results First Submitted QC: 2017-10-09
• Last Update Submitted: 2017-10-09
• Results First Posted: 2018-07-23
• Last Update Posted: 2018-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
CX516	CX516	CX516 - 900 mg

Primary Outcome Measures

Name	Time	Method
15-Item Word List Delayed Recall	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.

Trial Locations

Locations (8)

University of California Irvine; 🇺🇸 Irvine, California, United States

University of California at Los Angeles; 🇺🇸 Los Angeles, California, United States

Mercy Mayo Clinic; 🇺🇸 Des Moines, Iowa, United States

University of California, San Diego; 🇺🇸 San Diego, California, United States

Sun Coast Gerontology Center, University of South Florida; 🇺🇸 Tampa, Florida, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Pivotal Research Centers; 🇺🇸 Peoria, Arizona, United States

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States