Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT)

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to test the ability of the non-steroidal anti-inflammatory medications naproxen and celecoxib to delay or prevent the onset of AD and age-related cognitive decline.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Seattle Institute for Biomedical and Clinical Research
• Collaborators: Johns Hopkins University; National Institute on Aging (NIA); University of Washington; VA Puget Sound Health Care System
• Treatments: Anti-Inflammatory Agents; Celecoxib; Naproxen

Criteria

Inclusion Criteria:

• Aged 70 years or older.

• Family history of parent, brother, or sister who has, or had, serious age-related memory loss, senility, dementia, or Alzheimer's disease.

• Study partner available to provide information on the cognitive status of the participant and to assist with monitoring of trial medications, if needed.

• Sufficient fluency in written and spoken English to participate in study visits and neuropsychological testing.

• Willingness to limit use of the following for the duration of the study: vitamin E (at doses greater than 400 IU per day), non-aspirin NSAIDs, histamine H2 receptor antagonists (Tagamet, for example), corticosteroids, anti-inflammatory or analgesic doses of aspirin (greater than 81 mg per day), Ginkgo biloba extracts

• Ability and intention to participate in regular study visits, in the opinion of the study physician.

• Provision of informed consent.

Exclusion Criteria:

• History of peptic ulcer disease with bleeding or obstruction.

• Clinically significant liver or kidney disease.

• History of hypersensitivity to aspirin, ibuprofen, celecoxib, naproxen, or other NSAIDs.

• Use of anti-coagulant medication.

• Cognitive impairment or dementia.

• Current alcohol abuse or dependence