Delaying Alzheimer Disease Symptoms With Anti-Inflammatory Drugs

February 28, 2020 updated by: Gary Small, MD, University of California, Los Angeles

Anti-Inflammation in AD: PET Imaging Supplement

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.

Study Overview

Status

Completed

Intervention / Treatment

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

Interventional

Enrollment

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Los Angeles, California, United States, 90024
        • UCLA Neuropsychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2000

Primary Completion (ACTUAL)

November 1, 2005

Study Completion (ACTUAL)

November 1, 2005

Study Registration Dates

First Submitted

July 17, 2003

First Submitted That Met QC Criteria

July 17, 2003

First Posted (ESTIMATE)

July 18, 2003

Study Record Updates

Last Update Posted (ACTUAL)

March 2, 2020

Last Update Submitted That Met QC Criteria

February 28, 2020

Last Verified

February 1, 2020

More Information

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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