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Delaying Alzheimer Disease Symptoms With Anti-Inflammatory Drugs

Primary Purpose

Alzheimer Disease, Dementia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Celecoxib
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alzheimer Disease

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • UCLA Neuropsychiatric Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 17, 2003
Last Updated
February 28, 2020
Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00065169
Brief Title
Delaying Alzheimer Disease Symptoms With Anti-Inflammatory Drugs
Official Title
Anti-Inflammation in AD: PET Imaging Supplement
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
November 2000 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Dementia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
138 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Celecoxib

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Facility Information:
Facility Name
UCLA Neuropsychiatric Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States

12. IPD Sharing Statement

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Delaying Alzheimer Disease Symptoms With Anti-Inflammatory Drugs

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