title: Pilot tolerability studies of hydroxychloroquine and colchicine in Alzheimer disease.
abstract: Anti-inflammatory drugs may be useful in the treatment of Alzheimer disease (AD). In preparation for therapeutic trials, we conducted pilot feasibility studies of hydroxychloroquine alone and in combination with colchicine in subjects with AD. A total of 20 subjects with probable AD were treated with hydroxychloroquine 200 mg twice daily for 11 weeks, or hydroxychloroquine 200 mg twice daily plus colchicine 0.6 mg twice daily for 12 weeks; subjects were monitored for adverse medical, cognitive, or behavioral effects. Neither regimen caused adverse effects on cognitive or behavioral assessment scores. There were no significant side effects in subjects receiving hydroxychloroquine 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-scale therapeutic trials of these agents.
authors.affiliation: Department of Psychiatry, Mount Sinai School of Medicine, New York, New York, USA.
authors.forename: P S
authors.initials: PS
authors.lastname: Aisen
authors.forename: D B
authors.initials: DB
authors.lastname: Marin
authors.forename: A M
authors.initials: AM
authors.lastname: Brickman
authors.forename: J
authors.initials: J
authors.lastname: Santoro
authors.forename: M
authors.initials: M
authors.lastname: Fusco
mesh_terms: D000368:Aged; D000544:Alzheimer Disease / Q000175:diagnosis / Q000188:drug therapy*; D003078:Colchicine / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D006886:Hydroxychloroquine / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects
chemical_list: D006886:Hydroxychloroquine; D003078:Colchicine