Delaying Alzheimer Disease Symptoms With Anti-Inflammatory Drugs

Alzheimer Disease Clinical Trial

Official title:

Anti-Inflammation in AD: PET Imaging Supplement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00065169
• Other study ID #: R01MH058156
• Secondary ID: R01MH058156DSIR
• Status: Completed
• Phase: N/A
• Start date: November 2000
• Est. completion date: November 2005

Study information

• Verified date: February 2020
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

Drug:
• Celecoxib

Locations

Country	Name	City	State
United States	UCLA Neuropsychiatric Institute	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States,