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

RespireRx

Status and phase

Completed

Phase 2

Conditions

Mild Cognitive Impairment

Treatments

Drug: Placebo

Drug: CX516

Study type

Interventional

Funder types

Industry

Identifiers

NCT00040443

CORX-CX516-012.1

Details and patient eligibility

About

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.

Enrollment

175 patients

Sex

All

Ages

55 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.