At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 175 enrolled

Drug / intervention

CX516 +1 moredrug

Likely dose

CX516 900 mg three times dailyAI-extracted

Key inclusion· 2

✓Clinical diagnosis of mild cognitive impairment
✓Good general health with no additional diseases that would interfere with the study

Key exclusion· 6

✕Any significant neurologic disease other than suspected incipient Alzheimer's disease (e.g., Parkinson's disease, stroke, TIA, 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

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00040443

NCT00040443Phase 2Completed

Compare CT.gov

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.

RespireRx·interventional·Posted Jun 28, 2002·Updated Jul 23, 2018

In Brief

A Phase 2 clinical trial evaluating CX516 and Placebo for Mild Cognitive Impairment. Completed, enrolled 175 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsMild Cognitive Impairment

CountriesUnited States

Collaborators--

Timeline

Phase 2CompletedFinished

20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartApr 2002

First PostedJun 2002

Primary CompletionAug 2003

Study CompletionJun 2004

TodayJul 2026

First PostedJun 28, 2002

Enrollment StartApr 1, 2002

Primary CompletionAug 1, 2003

Study CompletionJun 1, 2004

TodayJul 2, 2026

Enrollment to primary: 1.3 yearsPosted 24.0 years ago

Interventions

CX516drug

Placebodrug