Phase 2
N=175
Efficacy And Safety Of CX516 In Elderly Participants With Mild Cognitive Impairment.
Mild Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT00040443 ↗Enrolled (actual)
175
Serious AEs
2.3%
Results posted
Jul 2018
Primary outcome: Primary: 15-Item Word List Delayed Recall — -0.3; -0.5 units on a scale - change from baseline — p=<.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CX516 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- RespireRx
- Primary completion
- Aug 2003
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 15-Item Word List Delayed Recall |
-0.3; -0.5 | <.05 sig |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00040443). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.