Evidence that inflammatory mechanisms contribute to neuronal injury in Alzheimer's disease suggests that anti-inflammatory medications may slow the rate of cognitive deterioration. We have selected two anti- inflammatory drugs for a therapeutic trial: hydroxychloroquine, an antimalarial agent with anti-inflammatory and immunomodulating effects useful in the treatment of rheumatic disease, and colchicine, an anti- inflammatory drug with anti-amyloidogenic activity. The trial employs a double-blind parallel design with three groups: hydroxychloroquine (200mg twice daily), colchicine (0.6mg twice daily) and placebo. A total of three hundred subjects will be randomized to the three groups. The duration of treatment will be one year, with monitoring for an additional three months. The primary outcome measure will be the one year change in the cognitive subscale of the Alzheimer's Disease Assessment Scale. Secondary outcome measures include the Clinical Dementia Rating Scale sum of boxes (CDR-SOB), the attainment of significant endpoints (death, institutionalization, 1 point worsening on the global CDR, 15 point decline on the ADCS activities of daily living (ADL) inventory), the CERAD Behavioral Rating Scale, and the ADCS global, quality of life and pharmacoeconomic scales.

National Institute of Health (NIH)
National Institute on Aging (NIA)
Research Project--Cooperative Agreements (U01)
Project #
Application #
Study Section
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
University of California San Diego
La Jolla
United States
Zip Code
Rockenstein, Edward; Ostroff, Gary; Dikengil, Fusun et al. (2018) Combined Active Humoral and Cellular Immunization Approaches for the Treatment of Synucleinopathies. J Neurosci 38:1000-1014
Edmonds, Emily C; Ard, M Colin; Edland, Steven D et al. (2018) Unmasking the benefits of donepezil via psychometrically precise identification of mild cognitive impairment: A secondary analysis of the ADCS vitamin E and donepezil in MCI study. Alzheimers Dement (N Y) 4:11-18
Chen, Yun-Fei; Ni, Xiao; Fleisher, Adam S et al. (2018) A simulation study comparing slope model with mixed-model repeated measure to assess cognitive data in clinical trials of Alzheimer's disease. Alzheimers Dement (N Y) 4:46-53
Jacobs, Diane M; Ard, M Colin; Salmon, David P et al. (2017) Potential implications of practice effects in Alzheimer's disease prevention trials. Alzheimers Dement (N Y) 3:531-535
Moussa, Charbel; Hebron, Michaeline; Huang, Xu et al. (2017) Resveratrol regulates neuro-inflammation and induces adaptive immunity in Alzheimer's disease. J Neuroinflammation 14:1
Sims, Rebecca (see original citation for additional authors) (2017) Rare coding variants in PLCG2, ABI3, and TREM2 implicate microglial-mediated innate immunity in Alzheimer's disease. Nat Genet 49:1373-1384
El-Agnaf, Omar; Overk, Cassia; Rockenstein, Edward et al. (2017) Differential effects of immunotherapy with antibodies targeting ?-synuclein oligomers and fibrils in a transgenic model of synucleinopathy. Neurobiol Dis 104:85-96
Jun, Gyungah R; Chung, Jaeyoon; Mez, Jesse et al. (2017) Transethnic genome-wide scan identifies novel Alzheimer's disease loci. Alzheimers Dement 13:727-738
Tarrant, Sarah D; Bardach, Shoshana H; Bates, Kendra et al. (2017) The Effectiveness of Small-group Community-based Information Sessions on Clinical Trial Recruitment for Secondary Prevention of Alzheimer's Disease. Alzheimer Dis Assoc Disord 31:141-145
Kennedy, Richard E; Cutter, Gary R; Wang, Guoqiao et al. (2017) Challenging Assumptions About African American Participation in Alzheimer Disease Trials. Am J Geriatr Psychiatry 25:1150-1159

Showing the most recent 10 out of 294 publications