- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00009230
Anti-Inflammatory Treatment for Age-Associated Memory Impairment: A Double-Blind Placebo-Controlled Trial
Study Overview
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, Alzheimer's 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 mg/d) 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 (e.g., APOE-4). Subjects receiving celecoxib are expected to show less evidence of cognitive decline than those receiving placebo. The proposed project builds upon our group's 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 (e.g., gastrointestinal, renal, etc.).
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90024
- UCLA Neuropsychiatric Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age-associated memory impairment (AAMI)
Exclusion Criteria:
- Use of cholinesterase inhibitors
- Any current major psychiatric disorder such as depression or mania
- Subjects who may be sensitive to potential side effects of celecoxib, including those with any evidence of renal disease or gastrointestinal disease or predisposition or risk for bleeding, particularly gastrointestinal
- Subjects with histories of congestive heart failure, hypertension, peptic ulcer disease, any bleeding disorder, or other medical conditions that might increase medical risks from NSAID sensitivity
- Current diagnosis or history of alcoholism or drug dependence
- Evidence of depression
- Subjects with a contraindication for MRI scan
- Sulfur allergy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: Double
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Gary W. Small, MD, University of California, Los Angeles
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Memory Disorders
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Celecoxib
Other Study ID Numbers
- IA0015
- R01MH058156 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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