A Randomised Double-blind Placebo-controlled Clinical Trial Investigating the Effect and Safety of Oral Semaglutide in Subjects With Early Alzheimer´s Disease (EVOKE Plus)
A Randomised Double-blind Placebo-controlled Clinical Trial Investigating the Effect and Safety of Oral Semaglutide in Subjects With Early Alzheimer´s Disease (EVOKE Plus)
This study is done to find out whether the medicine, semaglutide, has a positive effect on early Alzheimer's disease.
Participants will either get semaglutide or placebo (a "dummy" medicine which does not contain any study medicine) - which treatment participants get is decided by an equal chance.
The study will last for up to 173 weeks (about 3 years and 4 months). Participants will have 17 clinic visits and 1 phone call with the study doctor. The study includes various tests and scans. At 10 of the clinic visits participants will have blood samples taken.
Participants must have a study partner, who is willing to take part in the study.
Women cannot take part if pregnant, breastfeeding or plan to become pregnant during the study period.
A cerebrospinal fluid (CSF) sub-study will be performed as a part of the study. The sub-study will be performed on a selection of sites based on their experience with CSF sampling and willingness to participate in this sub-study. The endpoints related to this sub-study are exploratory only.
Inclusion Criteria:
Exclusion Criteria:
Ciudad de Buenos Aires, Buenos Aires C1405CWB, Argentina
CABA, 1427, Argentina
CABA, 1428, Argentina
Belo Horizonte, Minas Gerais 30130-100, Brazil
Porto Alegre, Rio Grande do Sul 90430-001, Brazil
Ottowa, Ontario K1Z 1G3, Canada
Beijing, Beijing Municipality 100020, China
Beijing, Beijing Municipality 100050, China
Beijing, Beijing Municipality 100070, China
Beijing, Beijing Municipality 100088, China
Chongqing, Chongqing Municipality 400016, China
Guangzhou, Guangdong 510260, China
Guangzhou, Guangdong 510370, China
Shanghai, Shanghai Municipality 200123, China
Shanghai, Shanghai Municipality 200233, China
Shanghai, Shanghai Municipality 200233, China
Hangzhou, Zhejiang 310003, China
Cologne, 50937, Germany
Chaidari, Athens, GR-12462, Greece
Tel Hashomer, Ramat Gan, 5262000, Israel
Roma, 00168, Italy
Anan, Tokushima, 774-0014, Japan
Bunkyo-ku, Tokyo, 113-0034, Japan
Bunkyo-ku,Tokyo, 113-8519, Japan
Bunkyo-ku,Tokyo, 113-8519, Japan
Fujioka-Shi, Gunma, 375-0017, Japan
Hamamatsu-shi, Shizuoka, 434-8511, Japan
Hamamatsu-shi, Shizuoka, 434-8511, Japan
Himeji-shi, Hyogo, 670-8560, Japan
Hiroshima-shi, Hiroshima, 732-0066, Japan
Hiroshima-shi, Hiroshima, 732-0822, Japan
Hiroshima-shi, Hiroshima, 732-0822, Japan
Kawasaki-shi, Kanagawa, 213-8507, Japan
Kobe-shi, Hyogo, 650-0017, Japan
Kobe-shi, Hyogo, 650-0017, Japan
Niigata-shi, Niigata, 950-0983, Japan
Niigata-shi, Niigata, 950-0983, Japan
Okayama-shi, Okayama, 703-8265, Japan
Shizuoka-shi, Shizuoka, 424-8636, Japan
Takamatsu-shi, Kagawa, 760-8557, Japan
Takamatsu-shi, Kagawa, 760-8557, Japan
Tokushima-shi, Tokushima, 770-0852, Japan
Yokohama-shi, Kanagawa, 223-0059, Japan
Senhora Da Hora, Matosinhos, Matosinhos 4464-513, Portugal
George, Eastern Cape 6529, South Africa
Altindag/Ankara, 06230, Turkey (Türkiye)
Altindag/Ankara, 06230, Turkey (Türkiye)
Balcova / Izmir, 35330, Turkey (Türkiye)
Kyiv, 04114, Ukraine