Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009230
Status:
COMPLETED
Last Update Posted:
2020-03-02
First Post:
2001-01-23
Brief Title:
Anti-Inflammatory Treatment for Age-Associated Memory Impairment A Double-Blind Placebo-Controlled Trial
Sponsor:
University of California Los Angeles
Organization:
University of California Los Angeles
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2020-02
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:
This project is designed to study whether anti-inflammatory drugs such as celecoxib may delay age-related mental decline We are also looking at genetic risk and brain structure as potential predictors of mental decline We believe people with age-associated memory impairment who take celecoxib will show less evidence of mental decline than those receiving placebo an inactive pill after 18 months We expect that brain structure at the start of the study memory performance as indicated by tests and age will be additional predictors of mental decline We also predict that cognitive decline ie decline in thinking and memory and treatment response will vary according to genetic factors that may correlate with the age at which dementia begins We believe other variables such as prior educational achievement memory capability at the outset of the study and gender may influence mental decline and treatment response We will study people with age-associated memory impairment mild memory complaints decreased performance in selected memory tests between 40 and 90 years of age The subjects will be randomly ie by a process similar to flipping a coin assigned to treatment groups The subjects will receive either an inactive substance placebo or celecoxib 400 mgday The subjects will receive a magnetic resonance imaging MRI scan FDG PET scan routine laboratory blood tests electrocardiogram and cognitive tests They will be followed for approximately 18 months and asked to return at specific intervals for follow-up testing Measures of brain structure will be derived from baseline MRI scans and metabolic activity from PET scans and blood will be drawn and tested to determine which forms genotypes of certain genetically determined cellular components the patient has
Detailed Description:
Several observational epidemiological studies indicate that anti-inflammatory treatments attenuate or prevent the symptoms of one of the most common mental disorders of late life Alzheimers disease AD Neuropathological studies also support inflammatory or immune mechanisms in AD including findings of reactive microglia within or near AD lesions Such evidence however is circumstantial and controlled randomized drug trials are needed to determine efficacy
This project is designed to determine if the commonly used nonsteroidal anti-inflammatory drug NSAID celecoxib is efficacious in delaying progression of cognitive symptoms in people with age-related cognitive losses who are at risk for developing AD A total of 135 subjects with age-associated memory impairment AAMI who are at risk for further cognitive decline age 40 to 90 years will be randomized double-blind design to one of two treatment groups celecoxib 400 mgd or placebo and followed for 18 months All randomized subjects will receive magnetic resonance imaging MRI scans FDG PET scans and selective genotyping apolipoprotein E APOE and genetic risk for AD onset eg APOE-4 Subjects receiving celecoxib are expected to show less evidence of cognitive decline than those receiving placebo The proposed project builds upon our groups prior work on early detection of AD using brain imaging genetic risk and neuropsychological assessments This project also is a logical follow-up to recent observational studies of a promising early intervention and will represent one of the first controlled anti-inflammatory treatment trials for persons at high risk for age-related cognitive decline and the eventual development of AD
Subjects will be followed closely to ensure that medication is safely used without side effects eg gastrointestinal renal etc
This project is designed to determine if the commonly used nonsteroidal anti-inflammatory drug NSAID celecoxib is efficacious in delaying progression of cognitive symptoms in people with age-related cognitive losses who are at risk for developing AD A total of 135 subjects with age-associated memory impairment AAMI who are at risk for further cognitive decline age 40 to 90 years will be randomized double-blind design to one of two treatment groups celecoxib 400 mgd or placebo and followed for 18 months All randomized subjects will receive magnetic resonance imaging MRI scans FDG PET scans and selective genotyping apolipoprotein E APOE and genetic risk for AD onset eg APOE-4 Subjects receiving celecoxib are expected to show less evidence of cognitive decline than those receiving placebo The proposed project builds upon our groups prior work on early detection of AD using brain imaging genetic risk and neuropsychological assessments This project also is a logical follow-up to recent observational studies of a promising early intervention and will represent one of the first controlled anti-inflammatory treatment trials for persons at high risk for age-related cognitive decline and the eventual development of AD
Subjects will be followed closely to ensure that medication is safely used without side effects eg gastrointestinal renal etc
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 |
|---|---|---|---|
| R01MH058156 | NIH | None | httpsreporternihgovquickSearchR01MH058156 |