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.

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

Sponsors

Lead sponsor: RespireRx

Source 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.

Overall Status Completed
Start Date April 2002
Completion Date June 2004
Primary Completion Date August 2003
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
15-Item Word List Delayed Recall 28 Days
Enrollment 175
Condition
Intervention

Intervention type: Drug

Intervention name: CX516

Arm group label: CX516

Intervention type: Drug

Intervention name: Placebo

Arm group label: Placebo

Eligibility

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.

Gender: All

Minimum age: 55 Years

Maximum age: 85 Years

Healthy volunteers: No

Location
facility
Pivotal Research Centers | Peoria, Arizona, 85381, United States
University of California Irvine | Irvine, California, 92697, United States
University of California at Los Angeles | Los Angeles, California, 90095, United States
University of California, San Diego | San Diego, California, 92093, United States
Yale University School of Medicine | New Haven, Connecticut, 06510, United States
Sun Coast Gerontology Center, University of South Florida | Tampa, Florida, 33617, United States
Mercy Mayo Clinic | Des Moines, Iowa, 50314, United States
University of Pittsburgh | Pittsburgh, Pennsylvania, 15213, United States
Location Countries

United States

Verification Date

October 2017

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: CX516

Arm group type: Experimental

Description: CX516 - 900 mg

Arm group label: Placebo

Arm group type: Placebo Comparator

Description: Placebo

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov