Delaying Alzheimer Disease Symptoms With Anti-Inflammatory Drugs

University of California, Los Angeles (UCLA)

Status

Completed

Conditions

Alzheimer Disease

Dementia

Treatments

Drug: Celecoxib

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00065169

R01MH058156 (U.S. NIH Grant/Contract)

DSIR AT-GP

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

40 to 90 years old

Volunteers

Accepts 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)