Completed

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.

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What is being tested

CX516

+ Placebo

Drug
Who is being recruted

Alzheimer Disease+13

+ Mental Disorders

+ Brain Diseases

From 55 to 85 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: April 2002
See protocol details

Summary

Principal SponsorRespireRx
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2002

Actual date on which the first participant was enrolled.

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.

Official TitleEfficacy 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.
NCT00040443
Principal SponsorRespireRx
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

175 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 55 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Alzheimer DiseaseMental DisordersBrain DiseasesCentral Nervous System DiseasesCognition DisordersDementiaMemory DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodegenerative DiseasesNeurobehavioral ManifestationsNeurocognitive DisordersTauopathiesCognitive Dysfunction

Criteria

2 inclusion criteria required to participate
Clinical diagnosis of mild cognitive impairment
Good general health with no additional diseases that would interfere with the study.
6 exclusion criteria prevent from participating
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.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
CX516 - 900 mg

Group II

Placebo
Placebo

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 8 locations

Suspended

Pivotal Research Centers

Peoria, United StatesOpen Pivotal Research Centers in Google Maps
Suspended

University of California Irvine

Irvine, United States
Suspended

University of California at Los Angeles

Los Angeles, United States
Suspended

University of California, San Diego

San Diego, United States
Completed8 Study Centers
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. | PatLynk