Ignite Creation Date:
2024-05-05 @ 1:26 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004845
Status:
COMPLETED
Last Update Posted:
2009-12-11
First Post:
2000-02-28
Brief Title:
A Multicenter Trial of Rofecoxib and Naproxen in Alzheimers Disease NSAID Study
Sponsor:
National Institute on Aging NIA
Organization:
National Institute on Aging NIA
Study Overview
Official Title:
A Multicenter Trial of Rofecoxib and Naproxen in Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2009-06
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:
The primary specific aim of this clinical trial is to determine whether treatment with rofecoxib or naproxen for one year will slow the rate of decline of cognitive function in patients with Alzheimers disease AD as measured by ADAScog
Detailed Description:
Evidence that inflammatory mechanisms contribute to neuronal injury in Alzheimers disease along with a number of epidemiological studies suggests that non-steroidal anti-inflammatory drugs NSAIDs may slow the rate of cognitive deterioration We have selected two such drugs for a therapeutic trial rofecoxib and naproxen The trial employs a double-blind parallel design with three primary treatment groups rofecoxib naproxen and placebo A total of 320 patients will be enrolled in the trial and randomized to the three groups Stable use of cholinesterase inhibitors estrogen low dose aspirin and vitamin E will be allowed Patients with inflammatory diseases that might respond to the study medications will be excluded
The primary outcome measure will be the one year change in the cognitive subscale of the Alzheimers Disease Assessment Scale ADAScog The attainment of significant endpoints will be examined as a secondary outcome measure Other secondary measures include the CDR sum-of-boxes Neuropsychiatric Inventory the Quality of Life-AD and the ADCS pharmacoeconomic scale The influence of HLA-DR Human Leukocyte Antigen genotype on clinical progression and response to treatment will also be examined
The primary outcome measure will be the one year change in the cognitive subscale of the Alzheimers Disease Assessment Scale ADAScog The attainment of significant endpoints will be examined as a secondary outcome measure Other secondary measures include the CDR sum-of-boxes Neuropsychiatric Inventory the Quality of Life-AD and the ADCS pharmacoeconomic scale The influence of HLA-DR Human Leukocyte Antigen genotype on clinical progression and response to treatment will also be examined
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