Anti-Inflammatory Treatment for Age-Associated Memory Impairment: A Double-Blind Placebo-Controlled Trial

NCT00009230 | Completed Phase 3

• 2 other identifiers: IA0015R01MH058156
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This project is designed to study whether anti-inflammatory drugs, such as celecoxib, may delay age-related mental decline. We are also looking at genetic risk and brain structure as potential predictors of mental decline. We believe people with age-associated memory impairment who take celecoxib will show less evidence of mental decline than those receiving placebo (an inactive pill) after 18 months. We expect that brain structure at the start of the study, memory performance as indicated by tests, and age will be additional predictors of mental decline. We also predict that cognitive decline (i.e., decline in thinking and memory) and treatment response will vary according to genetic factors that may correlate with the age at which dementia begins. We believe other variables such as prior educational achievement, memory capability at the outset of the study, and gender may influence mental decline and treatment response. We will study people with age-associated memory impairment (mild memory complaints, decreased performance in selected memory tests), between 40 and 90 years of age. The subjects will be randomly (i.e., by a process similar to flipping a coin) assigned to treatment groups. The subjects will receive either an inactive substance (placebo) or celecoxib (400 mg/day). The subjects will receive a magnetic resonance imaging (MRI) scan, FDG PET scan, routine laboratory blood tests, electrocardiogram and cognitive tests. They will be followed for approximately 18 months and asked to return at specific intervals for follow-up testing. Measures of brain structure will be derived from baseline MRI scans and metabolic activity from PET scans, and blood will be drawn and tested to determine which forms (genotypes) of certain genetically determined cellular components the patient has.

Conditions

Memory Disorders

Keywords

Age associated memory impairment; Mild cognitive impairment

Interventions

Celecoxib DRUG

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age-associated memory impairment (AAMI)

You may not qualify if:

• Use of cholinesterase inhibitors
• Any current major psychiatric disorder such as depression or mania
• Subjects who may be sensitive to potential side effects of celecoxib, including those with any evidence of renal disease or gastrointestinal disease or predisposition or risk for bleeding, particularly gastrointestinal
• Subjects with histories of congestive heart failure, hypertension, peptic ulcer disease, any bleeding disorder, or other medical conditions that might increase medical risks from NSAID sensitivity
• Current diagnosis or history of alcoholism or drug dependence
• Evidence of depression
• Subjects with a contraindication for MRI scan
• Sulfur allergy

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

Memory Disorders; Cognitive Dysfunction

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; 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 Officials

• Gary W. Small, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Biobehavioral Sciences

Study Record Dates

• First Submitted: January 23, 2001
• First Posted: January 24, 2001
• Study Start: June 1, 2000
• Primary Completion: June 1, 2005
• Study Completion: August 1, 2005
• Last Updated: March 2, 2020

Record last verified: 2020-02

Locations

US (1)