Delaying Alzheimer Disease Symptoms With Anti-Inflammatory Drugs
This study has been completed.
Sponsor:
University of California, Los Angeles
Collaborator:
Information provided by (Responsible Party):
Gary Small, MD, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00065169
First received: July 17, 2003
Last updated: February 26, 2013
Last verified: February 2013
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Purpose
The purpose of this study is to determine whether the anti-inflammatory drug celecoxib can delay the onset of Alzheimer Disease (AD) in people with Age Associated Memory Impairment (AAMI). This study will also evaluate genetic risk and brain structure as potential predictors of mental decline.
| Condition | Intervention |
|---|---|
|
Alzheimer Disease Dementia |
Drug: Celecoxib |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | Anti-Inflammation in AD: PET Imaging Supplement |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
Drug Information available for:
Celecoxib
U.S. FDA Resources
Further study details as provided by University of California, Los Angeles:
| Estimated Enrollment: | 138 |
| Study Start Date: | November 2000 |
| Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 40 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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)
Contacts and Locations More Information
No publications provided
| Responsible Party: | Gary Small, MD, UCLA Professor of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles |
| ClinicalTrials.gov Identifier: | NCT00065169 History of Changes |
| Other Study ID Numbers: | R01 MH58156, R01MH058156, DSIR AT-GP |
| Study First Received: | July 17, 2003 |
| Last Updated: | February 26, 2013 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Celecoxib Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions |
Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 16, 2013