Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001662
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Treatment of Alzheimers Disease With CX516 Ampalex
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Tolerability and Primary Efficacy of CX516 in Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2005-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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-23-dihydro-5 methyl 3-oxo-4-isoxazolepropanoic acid receptors The brain cells responsible for releasing glutamate are damaged in Alzheimers 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 Alzheimers 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 Alzheimers 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
Researchers would like to see if giving patients a drug that attaches to AMPA receptors improves the symptoms of Alzheimers 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 Alzheimers 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
Detailed 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 Alzheimers 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 97-N-0049 | None | None | None |