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Saito S, Kojima S, Oishi N, et al. A multicenter, randomized, placebo-controlled trial for cilostazol in patients with mild cognitive impairment: The COMCID study protocol. Alzheimers Dement (N Y). 2016;2(4):250-257doi: 10.1016/j.trci.2016.10.001.
Saito, S., Kojima, S., Oishi, N., Kakuta, R., Maki, T., Yasuno, F., Nagatsuka, K., Yamamoto, H., Fukuyama, H., Fukushima, M., & Ihara, M. (2016). A multicenter, randomized, placebo-controlled trial for cilostazol in patients with mild cognitive impairment: The COMCID study protocol. Alzheimer's & dementia (New York, N. Y.), 2(4), 250-257. https://doi.org/10.1016/j.trci.2016.10.001
Saito, Satoshi, et al. "A multicenter, randomized, placebo-controlled trial for cilostazol in patients with mild cognitive impairment: The COMCID study protocol." Alzheimer's & dementia (New York, N. Y.) vol. 2,4 (2016): 250-257. doi: https://doi.org/10.1016/j.trci.2016.10.001
Saito S, Kojima S, Oishi N, Kakuta R, Maki T, Yasuno F, Nagatsuka K, Yamamoto H, Fukuyama H, Fukushima M, Ihara M. A multicenter, randomized, placebo-controlled trial for cilostazol in patients with mild cognitive impairment: The COMCID study protocol. Alzheimers Dement (N Y). 2016 Oct 27;2(4):250-257. doi: 10.1016/j.trci.2016.10.001. eCollection 2016 Nov. PMID: 29067312; PMCID: PMC5651350.
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Alzheimers Dement (N Y). 2016 Oct 27;2(4):250-257. doi: 10.1016/j.trci.2016.10.001. eCollection 2016 Nov.

A multicenter, randomized, placebo-controlled trial for cilostazol in patients with mild cognitive impairment: The COMCID study protocol.

Alzheimer's & dementia (New York, N. Y.)

Satoshi Saito, Shinsuke Kojima, Naoya Oishi, Ryosuke Kakuta, Takakuni Maki, Fumihiko Yasuno, Kazuyuki Nagatsuka, Haruko Yamamoto, Hidenao Fukuyama, Masanori Fukushima, Masafumi Ihara

Affiliations

  1. Department of Regenerative Medicine and Tissue Engineering, National Cerebral and Cardiovascular Center, Suita, Japan.
  2. Department of Neurology, Kyoto University Graduate School of Medicine, Kyoto, Japan.
  3. Department of MediScience, Translational Research Informatics Center, Foundation for Biomedical Research and Innovation, Kobe, Japan.
  4. Human Brain Research Center, Kyoto University Graduate School of Medicine, Kyoto, Japan.
  5. Center for the Promotion of Interdisciplinary Education and Research, Kyoto University, Kyoto, Japan.
  6. Department of Stroke and Cerebrovascular Diseases, National Cerebral and Cardiovascular Center, Suita, Japan.
  7. Department of Psychiatry, Nara Medical University, Kashihara, Japan.
  8. Center for Advancing Clinical and Translational Sciences, National Cerebral and Cardiovascular Center, Suita, Japan.

PMID: 29067312 PMCID: PMC5651350 DOI: 10.1016/j.trci.2016.10.001

Abstract

INTRODUCTION: There are currently no effective treatments preventing conversion from mild cognitive impairment (MCI) to Alzheimer's disease. Cilostazol is a selective type-3 phosphodiesterase inhibitor that ameliorates accumulation of amyloid-β and has prevented cognitive decline in rodent models. Furthermore, cilostazol is known to suppress platelet aggregation, protect vascular endothelia, dilate vessels, and increase cerebral blood flow. Beneficial effects have also been shown in observational cohort studies, demonstrating the need for a prospective clinical trial.

METHODS: The Cilostazol for prevention of COnversion from MCI to Dementia (COMCID) study is a double-blind, randomized phase II study of patients with MCI. Participants will receive cilostazol or placebo for 96 weeks. The primary objective is to evaluate whether cilostazol slows down cognitive decline measured by the Mini-Mental State Examination. Secondary objectives are assessing time to conversion from MCI to dementia and assessing incremental changes in several psychological assessment scales.

DISCUSSION: The COMCID trial will identify the therapeutic potential of cilostazol. This trial, which is based on a drug repositioning strategy, may aid the development of a neurovascular treatment for neurocognitive disorders.

Keywords: Alzheimer's disease; Cilostazol; Clearance; Clinical trial; Drug repositioning

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