Delaying Alzheimer Disease Symptoms With Anti-Inflammatory Drugs

This study has been completed.
Sponsor:
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
  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:


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)
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00065169

Locations
United States, California
UCLA Neuropsychiatric Institute
Los Angeles, California, United States, 90024
Sponsors and Collaborators
University of California, Los Angeles
  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 July 24, 2014