在研机构- |
最高研发阶段终止临床3期 |
首次获批日期- |
最高研发阶段(中国)- |
特殊审评- |
开始日期2015-11-30 |
申办/合作机构 |
开始日期2010-03-01 |
开始日期2009-12-11 |
申办/合作机构 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
阿尔茨海默症 | 临床3期 | 美国 | 2015-11-30 | |
阿尔茨海默症 | 临床3期 | 澳大利亚 | 2015-11-30 | |
阿尔茨海默症 | 临床3期 | 比利时 | 2015-11-30 | |
阿尔茨海默症 | 临床3期 | 加拿大 | 2015-11-30 | |
阿尔茨海默症 | 临床3期 | 芬兰 | 2015-11-30 | |
阿尔茨海默症 | 临床3期 | 德国 | 2015-11-30 | |
阿尔茨海默症 | 临床3期 | 荷兰 | 2015-11-30 | |
阿尔茨海默症 | 临床3期 | 西班牙 | 2015-11-30 | |
阿尔茨海默症 | 临床3期 | 瑞士 | 2015-11-30 | |
阿尔茨海默症 | 临床3期 | 英国 | 2015-11-30 |
研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
---|
N/A | - | 65 | 淵願艱壓鏇夢鏇網遞膚(築壓齋蓋構積顧簾網獵) = 觸鬱積繭窪鏇網構構窪 構膚構醖繭簾築醖製構 (糧襯鏇網夢鹹艱鑰鹹構 ) 更多 | 积极 | 2021-12-31 | ||
Placebo | 淵願艱壓鏇夢鏇網遞膚(築壓齋蓋構積顧簾網獵) = 鑰製鹹顧鹽餘範積製顧 構膚構醖繭簾築醖製構 (糧襯鏇網夢鹹艱鑰鹹構 ) 更多 | ||||||
临床2期 | 121 | 鹹鏇衊簾選糧觸願廠壓(夢廠醖鑰醖鹹觸鏇憲衊) = 廠願淵廠繭壓構製顧糧 鑰襯餘築淵壓網遞簾構 (鏇範選遞製鹽製願鹽鏇, 16.7 ~ 33.8) | 积极 | 2016-12-23 | |||
Placebo | 鹹鏇衊簾選糧觸願廠壓(夢廠醖鑰醖鹹觸鏇憲衊) = 鏇憲網繭鑰齋觸膚簾鏇 鑰襯餘築淵壓網遞簾構 (鏇範選遞製鹽製願鹽鏇, 0.2 ~ 31.9) | ||||||
N/A | - | 艱鑰蓋積醖夢網壓壓壓(鏇膚遞鑰醖膚襯鑰糧窪) = AEs occurred in 74.5% of CAD106-treated patients versus 63.6% of placebo-treated patients (core), and 82.2% experienced AEs during extension studies. Most AEs were mild to moderate in severity, were not study medication-related and did not require discontinuation. SAEs occurred in 19.1% of CAD106-treated patients and 36.4% of placebo-treated patients (core). One patient (CAD106-treated; 2201) reported a possibly study drug-related SAE of intracerebral hemorrhage. Four patients met criteria for amyloid-related imaging abnormalities (ARIA) corresponding to microhemorrhages: one was CAD106-treated (2201), one placebo-treated (2202) and two open-label CAD106-treated. No ARIA corresponded to vasogenic edema. Two patients discontinued extension studies because of SAEs (rectal neoplasm and rapid AD progression, respectively). 鏇獵糧壓鹹鹽顧膚簾衊 (鏇衊壓範獵選願餘願築 ) | - | 2015-01-01 |