MCI or mild dementia of the Alzheimer type
Conditions
Interventions
treatment with oral semaglutide/placebo OD
Sponsors
Ohsugi Toshiaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. MCI or mild dementia of the Alzheimer type according to the NIA-AA 2018 criteria. 2. CDR global score of 0.5 and CDR of 0.5 or more in at least one of the three instrumental activities of daily living categories (personal care, home & hobbies, community affairs) Or CDR global score of 1.0 3. RBANS delayed memory index score of =22 5. Amyloid positivity established with either amyloid PET or CSF Abeta1-42. 6. If receiving an approved Alzheimer disease treatment (such as acetylcholinesterase inhibitors or memantine) the dose must have been stable for at least 3 months prior to screening and should not be changed during the trial unless medically necessary.
Exclusion criteria
Exclusion criteria: 1. Brain MRI (or CT) scan suggestive of clinically significant structural CNS disease confirmed by central read (e.g. cerebral large-vessel disease [large vessel (cortical) infarcts >10 mm in diameter], prior macro-haemorrhage [>1 cm3], cerebral vascular malformations, cortical hemosiderosis, intracranial aneurism(s), intracranial tumours, changes suggestive of normal pressure hydrocephalus). 2. Brain MRI (or CT) scan suggestive of significant small vessel pathology confirmed by central read and defined as >1 lacunar infarct and/or ARWMC >2, (WM >20 mm). 3. Brain MRI (or CT) scan suggestive of strategic infarcts defined as bilateral thalamic lacunar infarcts and singular paramedian thalamic infarcts confirmed by central read. 4. Evidence of a relevant neurological disorder other than MCI or mild dementia of the Alzheimer type at screening, including but not limited to Parkinson disease, Lewy body disease, frontotemporal dementia of any type, Huntington disease, amyotrophic lateral sclerosis, multiple sclerosis, systemic lupus erythematosus, progressive supranuclear palsy, neurosyphilis, HIV, learning disability, intellectual disability, hypoxic cerebral damage, or significant head trauma with loss of consciousness that led to persistent cognitive deficits. 5. Evidence of a clinically relevant or unstable psychiatric disorder, based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria, including schizophrenia or other psychotic disorder, or bipolar disorder. A subject with a history of major depression who has not had an episode in the last 24 months before the day of screening and is considered in remission or whose depression is controlled with treatment can be included in the trial per investigator judgement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) score | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Croatia, Czech, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Korea, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Slovenia, South
Contacts
Public ContactToshiaki Ohsugi
Novo Nordisk Pharma Ltd.
Outcome results
None listed