Phase
Condition
Neurologic Disorders
Treatment
Semaglutide
Placebo
Clinical Study ID
Ages 55-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female, aged 55-75 years (both inclusive) at the time of signing theinformed consent
Mild cognitive impairment (MCI) or mild dementia of the Alzheimer's type accordingto the National Institute on Aging- Alzheimer's Association (NIA-AA) 2018 criteria
Clinical dementia rating (CDR) global score of 0.5 or 1 at screening (visit 1)
Amyloid positivity established with either historical amyloid positron emissiontomography (PET) or historical cerebrospinal fluid (CSF) Aβ1-42 or historical CSFAβ1-42/Aβ1-40 (historical data within the last 5 years) or blood sample for amyloidbiomarker (Aβ42/Aβ40 ratio and p-tau217/np-tau217 ratio) at screening (visit 1)
Treated with acetylcholinesterase inhibitors (approved for the treatment ofAlzheimer's disease) and on stable dose for greater than 90 days before screening (visit 1)
Exclusion
Exclusion Criteria:
Brain magnetic resonance imaging (MRI) scan suggestive of clinically significantstructural central nervous system (CNS) disease confirmed by local read (examplecerebral large-vessel disease [large vessel (cortical) infarcts greater than 10millimeter (mm) in diameter], prior macro-haemorrhage [greater than 1centimeter cube (cm^3)], cerebral vascular malformations, cortical hemosiderosis, intracranialaneurism(s), intracranial tumours, changes suggestive of normal pressurehydrocephalus)
Brain MRI scan suggestive of significant small vessel pathology confirmed by localread and defined as greater than 1 lacunar infarct and/or white matterhyperintensity (WMH) Fazekas13 scale greater than 2, (white matter [WM] greater than 20 mm) in the deep white matter and periventricular regions
History or evidence of autoimmune diseases such as inflammatory bowel disease,rheumatoid arthritis, lupus, glomerulonephritis, psoriasis (but not limited to): Anyother medical condition that would require use of systemic corticosteroids orimmunosuppressants or immunostimulants in the 12 months prior to screening (visit 1)
Received a vaccine product (including booster) 4 weeks prior to screening (visit 1)or expected to receive a vaccine product (including booster) before visit 5
Use of any systemic immunomodulating drugs (small molecules and/or biologics) in thelast 12 months prior to screening (visit 1) or anticipated use of such drugs duringstudy intervention period 1 (i.e., during the first 12 weeks of treatment untilvisit 5), such as corticosteroids for systemic use, immunostimulants andimmunosuppressants
Study Design
Connect with a study center
Novo Nordisk Investigational Site
Ottawa, Ontario K1Z 1G3
CanadaActive - Recruiting
Ottawa Memory Clinic
Ottawa, Ontario K1Z 1G3
CanadaSite Not Available
Memory Program
Toronto, Ontario M3B2S7
CanadaSite Not Available
Novo Nordisk Investigational Site
Toronto, Ontario M3B2S7
CanadaSite Not Available
Novo Nordisk Investigational Site
København Ø, 2100
DenmarkSite Not Available
Rigshospitalet - afsnit 8015
København Ø, 2100
DenmarkSite Not Available
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25123
ItalySite Not Available
Novo Nordisk Investigational Site
Brescia, 25123
ItalySite Not Available
Azienda Ospedaliera di Perugia;Ospedale S. Maria della Miser
Perugia, 06132
ItalySite Not Available
Novo Nordisk Investigational Site
Perugia, 06132
ItalySite Not Available
Fondazione Santa Lucia IRCCS
Roma, 00179
ItalySite Not Available
Novo Nordisk Investigational Site
Roma, 00179
ItalySite Not Available
Karolinska Universitetssjukhuset, Huddinge
Stockholm, 141 86
SwedenSite Not Available
Novo Nordisk Investigational Site
Stockholm, 141 86
SwedenActive - Recruiting
Centre de la Mémoire
Genève, 1205
SwitzerlandSite Not Available
Novo Nordisk Investigational Site
Genève, 1205
SwitzerlandActive - Recruiting
Banner Sun Health Research Institute
Sun City, Arizona 85351
United StatesSite Not Available
Novo Nordisk Investigational Site
Sun City, Arizona 85351
United StatesActive - Recruiting
Brain Matters Research
Delray Beach, Florida 33445
United StatesSite Not Available

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