Feb. 12, 2023 |
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Aug. 28, 2023 |
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jRCT2031220635 |
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of BIIB080 in Subjects with Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease Dementia |
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Phase 2 Study of BIIB080 in Participants with MCI Due to AD or Mild AD Dementia |
Toda Yasuo |
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Biogen Japan Ltd. |
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Nihonbashi 1-chome Mitsui Building 14F, 1-4-1, Nihonbashi, Chuo-ku, Tokyo, 103-0027 |
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+81-120-560-086 |
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japan-medinfo@biogen.com |
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Biogen Japan Medical Information |
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Biogen Japan Ltd. |
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Nihonbashi 1-chome Mitsui Building 14F, 1-4-1, Nihonbashi, Chuo-ku, Tokyo, 103-0027 |
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+81-120-560-086 |
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japan-medinfo@biogen.com |
Recruiting |
May. 31, 2023 |
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April. 25, 2023 | ||
735 | ||
Interventional |
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randomized controlled trial |
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double blind |
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placebo control |
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parallel assignment |
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treatment purpose |
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1. Must meet all the clinical staging criteria for MCI due to AD (Stage 3) or mild AD dementia (Stage 4) according to the NIA-AA and must have the following at Screening Visit 1: |
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1. Known allergy to BIIB080 or a history of hypersensitivity to any of the inactive ingredients in the drug product . |
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50age old over | ||
80age old under | ||
Both |
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Alzheimer's Disease Dementia |
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Research Name: BIIB080 (previously known as ISIS |
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Dose-response in change from Baseline to Week 76 on the CDR-SB |
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- Change from Baseline to Week 76 on the CDR-SB |
Biogen Japan Ltd. |
Nippon Medical School Musashikosugi Hospital IRB | |
1-383 Kosugi-machi, Nakahara-ku, Kawasaki-shi, Kanagawa | |
+81-44-733-5181 |
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tiken@nms.ac.jp | |
Approval | |
Yes |
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In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on http://clinicalresearch.biogen.com/ |
NCT05399888 | |
Clinical Trial Gov |
USA/Canada/Denmark/Finland/Sweden/Poland/Germany/Czech Republic/Netherlands/Belgium/Switzerland/France/UK/Spain/ Italy/Australia |