A Randomised Double-blind Placebo-controlled Clinical Trial Investigating the Effect and Safety of Oral Semaglutide in Subjects With Early Alzheimer´s Disease (EVOKE)
A Randomised Double-blind Placebo-controlled Clinical Trial Investigating the Effect and Safety of Oral Semaglutide in Subjects With Early Alzheimer´s Disease (EVOKE)
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
Cologne, 50937, Germany
Mannheim, 68159, 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
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
Lørenskog, 1474, Norway
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