- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00065169
Delaying Alzheimer Disease Symptoms With Anti-Inflammatory Drugs
Anti-Inflammation in AD: PET Imaging Supplement
Study Overview
Detailed Description
AD is one of the most common mental disorders of late life. Preliminary studies indicate that anti-inflammatory drugs may attenuate or prevent AD symptoms, but efficacy trials are needed.
Participants in this study will be randomly assigned to receive either celecoxib or placebo for 18 months. Participants will undergo positron emission tomography (PET) and magnetic resonance imaging (MRI) scans of the brain. Routine laboratory blood tests, cognitive tests, and an electrocardiogram (ECG) will be performed. Participants will also be screened for Parkinson disease. Follow-up testing will be conducted at specific intervals following the study.
Study Type
Enrollment
Phase
- Not Applicable
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:
- NIMH diagnostic criteria for Age Associated Memory Impairment (AAMI)
- Mini-Mental State Examination (MMSE) score between 26 and 30 (unless < 8 years of educational achievement)
- No significant cerebrovascular disease
- Estrogen replacement therapy and thyroid replacement therapy (if the participant is euthyroid) are permitted if the therapies are stable for > 1 month
- Memory and verbal fluency cut-off scores that increase the probability of incipient dementia (Buschke-Fuld: 34; verbal fluency: 46 for letters, 7 for categories; Benton Visual Retention: 5)
- Adequate visual and auditory acuity to allow neuropsychological testing
- Normal screening laboratory tests and electrocardiogram (ECG)
Exclusion Criteria:
- Possible or probable Alzheimer Disease (AD) or other dementia
- Neurologic or other physical illness that could produce cognitive deterioration
- History of transient ischemic attacks (TIAs), carotid bruits, or lacunes on an MRI scan
- History of myocardial infarction within the previous year or unstable cardiac disease
- Uncontrolled hypertension (systolic BP > 170 or diastolic BP > 100)
- History of significant liver disease, pulmonary disease, diabetes, or cancer
- DSM-IV criteria for major psychiatric disorders within the previous 2 years
- Past or present history of alcoholism or drug dependence
- Untreated depression as determined by a Hamilton Depression Rating Scale (HAM-D) score of 12 or more
- Drugs that may significantly affect psychometric test results
- Centrally active beta-blockers, narcotics, clonidine, anti-Parkinsonian medications, antipsychotics, benzodiazepines, systemic corticosteroids, medications with significant cholinergic or anticholinergic effects, anti-convulsants, warfarin, vitamins other than the standard multivitamin supplement, ginkgo biloba, and any nutraceuticals. Occasional chloral hydrate use will be allowed, but discouraged, for insomnia.
- Investigational drugs within the previous month or longer, depending on drug half-life
- Contraindication for MRI scan (e.g., metal in body, claustrophobia)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
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
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Dementia
- Tauopathies
- Alzheimer Disease
- 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
- R01MH058156 (U.S. NIH Grant/Contract)
- DSIR AT-GP
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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