A clinical study on the effect of semaglutide on the immune system and other biological processes in people with Alzheimer's disease
Zusammenfassung der Studie
This is a study aimed at evaluating the effects of semaglutide on the immune system and other biological processes in people with Alzheimer's disease. The treatment of patients with the drug semaglutide or placebo (an inactive dummy drug) is decided by chance. This study is "double-blind", meaning that neither the participants nor the study staff know the distribution between the groups.
(BASEC)
Untersuchte Intervention
The total duration of the study is 1 and a half years for each patient and includes 12 visits to the study center.
The study begins with a selection period to ensure that patients meet the inclusion criteria. There will then be a treatment period of 64 weeks divided into two phases: during the first 12 weeks, patients will receive either semaglutide (the tested drug) or placebo (an inactive dummy drug), which is decided at random (patients will have exactly the same chance of receiving semaglutide as placebo). In the following 52 weeks, all individuals participating in the study will receive semaglutide. The study drug must be injected into the patient by their study partner once a week under the skin using an injection pen.
The study will conclude with a 5-week observation period after the last dose of the study drug.
During the selection period, it is planned to use a brain scan (MRI) to examine the structure of the brain. During visits to the study center, there will be various examinations (e.g., height, weight, electrocardiogram, cognitive tests, questionnaires) and blood samples taken. Additionally, during two visits, there will also be a collection of cerebrospinal fluid samples.
(BASEC)
Untersuchte Krankheit(en)
Alzheimer's disease
(BASEC)
- Male or female, aged 55 to 75 years - Mild cognitive impairment (MCI) or mild Alzheimer's type dementia - Clinical dementia rating (Clinical Dementia Rating – CDR) with a score of 0.5 or 1 at the selection visit (visit 1). - Established amyloid positivity with either a positron emission tomography (PET) or a historical cerebrospinal fluid (CSF) sample, or a blood sample for the amyloid biomarker at selection. - Treated with acetylcholinesterase inhibitors (approved for the treatment of Alzheimer's disease) and on a stable dose for > 90 days before the selection visit (visit 1). All study participants must have a companion (study partner). (BASEC)
Ausschlusskriterien
- Magnetic resonance imaging (MRI) of the brain indicating a clinically significant structural disease of the central nervous system (CNS). - MRI of the brain suggesting significant small vessel pathology. - History or evidence of autoimmune diseases such as inflammatory bowel disease, rheumatoid arthritis, lupus, glomerulonephritis, psoriasis, and any other medical condition that would require the use of systemic corticosteroids or immunosuppressants or immunostimulants in the 12 months prior to the selection visit (visit 1). - Receipt of a vaccine product (including a booster) 4 weeks before the selection visit (visit 1) or plans to receive one before visit 5. - Use of any systemic immunomodulatory drug in the 12 months prior to the selection visit or planned use of such drugs during the first 12 weeks of treatment until visit 5. (BASEC)
Studienstandort
Genf
(BASEC)
Sponsor
Novo Nordisk Pharma AG
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Abteilung klinische Studien
+41 44 914 11 11
io-nwe-ch-clinical@clutternovonordisk.comNovo Nordisk Pharma AG
(BASEC)
Wissenschaftliche Auskünfte
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Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Genf
(BASEC)
Datum der Bewilligung durch die Ethikkommission
09.10.2023
(BASEC)
ICTRP Studien-ID
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Offizieller Titel (Genehmigt von der Ethikkommission)
A randomised double-blind placebo-controlled clinical study investigating the effects of semaglutide s.c. once-weekly versus placebo on central and peripheral inflammation in participants with Alzheimer’s disease (BASEC)
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Ergebnisse der Studie
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