Follow-up to last week's lay article on cognitive function and anti-inflammatories

After last week's lay article and discussion on cognitive function and the use of anti-inflammatories I wanted to follow-up with more specifics on the research study and the complete reference for the paper if you wanted to read further.

Study Design:
2528 participants randomized in 1:1:1.5 fashion to either 200mg of celecoxib twice daily, 220mg naproxen sodium twice daily or placebo (n= 726, 719, 1083) respectively.

Participant eligibility:
Participants were recruited from 6 sites around the country (Boston,MA, Rochester, NY, Balitmore, MD, Seattle, WA, Tampa, FL, Suncity, AZ) through mailers to medicare beneficiaries in targeted age and zip code ranges. Paticipants were then sub-divided into age groups (70-74, 75-79 and >80 years)and also had to have a first degree relative with Alzheimer's disease type dementia, score satisfactorily on cognitive battery test, and did not regularly take NSAIDs (with the exception of 81mg aspirin).


Data collection:
Participants completed a series of cognitive tests prior to randomization, including modified mini-mental state examination, the Hopkins learning verbal test revised and the informant rated dementia severity rating scale. After randomization the following tests were also administered the Digit Span Test, a generative verbal fluency of naming as many supermarket items as possible in 1 minute, narratives
from the Rivermead Behavioral Memory Test, the Brief Visuospatial Memory Test–Revised, self-rating of memory functions, and the Geriatric Depression Scale. The cognitive battery was then administered annually there after.

Study results:
The study was designed to last for 7 years, however was stopped after 4 years due to the fear of increased risk of cardiovascular events in participants taking celecoxib after observations from another trial reported increases in cardiovascular events for participants on celecoxib. In these 4 years study investigators saw no difference in cognitive function between the 3 study groups.

Reference:
ADAPT Research Group, Cognitive function over time in the Alzheimer's disease anti-inflammatory prevention trial (ADAPT), Arch Neurol, 2008;65(7):896-905.