Pilot tolerability studies of hydroxychloroquine and colchicine in Alzheimer disease

Anti-inflammatory drugs may be useful in the treatment of Alzheimer disease (AD). In preparation for therapeutic trials, we conducted pilot feasibilit y studies of hydroxychloroquine alone and in combination with colchicine in subjects with AD. A total of 20 subjects with probable AD were treated wit h hydroxychloroquine 200 mg twice daily for 11 weeks, or hydroxychloroquine 200 mg twice daily plus colchicine 0.6 mg twice daily for 12 weeks; subjec ts were monitored for adverse medical, cognitive, or behavioral effects. Ne ither regimen caused adverse effects on cognitive or behavioral assessment scores. There were no significant side effects in subjects receiving hydrox ychloroquine alone; 2 subjects receiving the two drugs together experienced diarrhea. We conclude that these regimens of anti-inflammatory therapy are well tolerated in subjects with AD, indicating the feasibility of large-sc ale therapeutic trials of these agents.