Delaying Alzheimer Disease Symptoms With Anti-Inflammatory Drugs

NCT00065169 | Completed

• 2 other identifiers: R01MH058156DSIR AT-GP
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Dementia

Interventions

Celecoxib DRUG

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

UCLA Neuropsychiatric Institute

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: UCLA Professor of Psychiatry and Biobehavioral Sciences

Study Record Dates

• First Submitted: July 17, 2003
• First Posted: July 18, 2003
• Study Start: November 1, 2000
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: March 2, 2020

Record last verified: 2020-02

Locations

US (1)