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A randomised double-blind placebo-controlled clinical trial investigating the effect and safety of oral semaglutide in subjects with early Alzheimer disease (EVOKE plus)(NN6535-4725) (EVOKE plus)

A randomised double-blind placebo-controlled clinical trial investigating the effect and safety of oral semaglutide in subjects with early Alzheimer disease (EVOKE plus)

Ohsugi Toshiaki

Novo Nordisk Pharma Ltd.

2-1-1, Marunouchi, Chiyodaku, Tokyo

JPHC_clinical_trials@novonordisk.com

Ohsugi Toshiaki

Novo Nordisk Pharma Ltd.

2-1-1, Marunouchi, Chiyodaku, Tokyo

+81-362661000

JPHC_clinical_trials@novonordisk.com

Not Recruiting

May. 18, 2021

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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 <=85
4. MMSE>=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.

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 strategic infarcts defined as bilateral thalamic lacunar infarcts and singular paramedian thalamic infarcts confirmed by central read.
3. 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.
4. 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.

Both

MCI or mild dementia of the Alzheimer type

treatment with oral semaglutide/placebo OD

Change in the Clinical Dementia Rating - Sum of Boxes (CDR-SB) score

+81-42-648-5551

April. 23, 2021

Argentina/Australia/Austria/Belgium/Brazil/Bulgaria/Canada/China/Croatia/Czech/Denmark/Finland/France/Germany/Greece/Hungary/Ireland/Israel/Italy/Korea/Netherlands/Poland/Portugal/Romania/Russia/Serbia/Slovakia/Slovenia/South Africa/Spain