Treatment of Alzheimer's Disease With CX516 (Ampalex)

Status Completed

Clinical Trial Summary

Glutamate is an amino acid released by brain cells that acts to excite other cells. Glutamate attaches to special sites on cells called AMPA (alpha-amino-2,3-dihydro-5 methyl 3-oxo-4-isoxazolepropanoic acid) receptors. The brain cells responsible for releasing glutamate are damaged in Alzheimer's disease and other conditions affecting thinking and reasoning.

Researchers would like to see if giving patients a drug that attaches to AMPA receptors improves the symptoms of Alzheimer's disease.

CX516 (Ampalex) is a test drug that affects the AMPA receptors. This study will investigate the effectiveness and safety of CX516 on patients with Alzheimer's disease.

Patients will be given capsules of CX516 or placebo (sugar pill that neither harms nor helps) for up to 16 weeks in different amounts. The effectiveness of the drug will be measured by neurological tests. Safety will be monitored by frequent check-ups and lab examinations.

Clinical Trial Description

Stimulation of neuronal excitatory amino acid receptors is an important step in the formation of memory. It is unknown whether stimulation of these receptors in patients with Alzheimer's disease and dementing disorders will improve cognitive function. To determine whether positive modulation of AMPA receptors, active in animal models of dementia, can improve cognitive function in demented patients, CX516, at a dose of 900mg TID, will be administered orally for 12 weeks in patients with dementia. In this randomized, controlled proof-of-principle study, drug-induced alterations in intellectual function will be measured by standardized neuropsychological tests. Safety will be monitored by frequent clinical assessments and laboratory tests. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00001662
Study type	Interventional
Source	National Institutes of Health Clinical Center (CC)
Contact
Status	Completed
Phase	Phase 2
Start date	December 1996
Completion date	November 2005

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