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

• 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: RespireRx
• Information provided by (Responsible Party): RespireRx

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

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

RespireRx

More Information

• Responsible Party: RespireRx
• ClinicalTrials.gov Identifier: NCT00040443
• Other Study ID Numbers: CORX-CX516-012.1
• First Posted: June 28, 2002
• 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:

Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders