Clinical trial NCT00040443: Efficacy And Safety Of CX516 In Elderly Participants With Mild Cognitive Impairment.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment
Memory Loss
Alzheimer's Disease
Brain Aging
Ampalex®
CX516
Lead sponsor: RespireRx
Sponsor class: INDUSTRY
First posted: 2002-06-28
Enrollment: 175
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 15-Item Word List Delayed Recall
timeFrame: 28 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Pivotal Research Centers
state: Arizona
city: Irvine
country: United States
facility: University of California Irvine
state: California
city: Los Angeles
country: United States
facility: University of California at Los Angeles
state: California
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Tampa
country: United States
facility: Sun Coast Gerontology Center, University of South Florida
state: Florida
city: Des Moines
country: United States
facility: Mercy Mayo Clinic
state: Iowa
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
References: