Clincosm LogoSign in Get a demo

Delaying Alzheimer Disease Symptoms With Anti-Inflammatory Drugs

Sponsor
University of California, Los Angeles (Other)
Overall Status
Completed
CT.gov ID
NCT00065169
Collaborator
National Institute of Mental Health (NIMH) (NIH)
138
Enrollment
1
Location
60
Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Prevention
Official Title:
Anti-Inflammation in AD: PET Imaging Supplement
Study Start Date :
Nov 1, 2000
Actual Primary Completion Date :
Nov 1, 2005
Actual Study Completion Date :
Nov 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 90 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 UCLA Neuropsychiatric Institute Los Angeles California United States 90024

    Sponsors and Collaborators

    • University of California, Los Angeles
    • National Institute of Mental Health (NIMH)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gary Small, MD, UCLA Professor of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles
    ClinicalTrials.gov Identifier:
    NCT00065169
    Other Study ID Numbers:
    • R01MH058156
    • R01MH058156
    • DSIR AT-GP
    First Posted:
    Jul 18, 2003
    Last Update Posted:
    Mar 2, 2020
    Last Verified:
    Feb 1, 2020
    Additional relevant MeSH terms:
    Alzheimer Disease
    Celecoxib

    Study Results

    No Results Posted as of Mar 2, 2020