Clinical trial: A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE Plus) (NCT04777409)

Eligibility criteria:
Inclusion Criteria:

          -  Male or female, aged 55-85 years (both inclusive) at the time of signing informed
             consent.

          -  MCI (mild cognitive impairment) or mild dementia of the Alzheimer's type according to
             the NIA-AA (National Institute of Aging-Alzheimer's Association) 2018 criteria.

          -  CDR (Clinical Dementia Rating) 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

          -  RBANS (Repeatable Battery for the Assessment of Neuropsychological Status) delayed
             memory index score of below or equal to 85

          -  MMSE (Mini-Mental State Examination) greater than or equal to 22

          -  Amyloid positivity established with either amyloid PET (positron emission tomography)
             or CSF (cerebrospinal fluid) Aβ1-42.

          -  If receiving an approved Alzheimer's 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:

          -  Brain MRI (or CT) scan suggestive of clinically significant structural CNS (central
             nervous system) disease confirmed by central read (e.g. cerebral large-vessel disease
             [large vessel (cortical) infarcts greater than10 mm in diameter], prior
             macro-haemorrhage [greater than1 cm^3], cerebral vascular malformations, cortical
             hemosiderosis, intracranial aneurism(s), intracranial tumours, changes suggestive of
             normal pressure hydrocephalus).

          -  Brain MRI (magnetic resonance imaging) (or CT) scan suggestive of strategic infarcts
             defined as bilateral thalamic lacunar infarcts and singular paramedian thalamic
             infarcts confirmed by central read.

          -  Evidence of a relevant neurological disorder other than MCI or mild dementia of the
             Alzheimer's type at screening, including but not limited to Parkinson's disease, Lewy
             body disease, frontotemporal dementia of any type, Huntington's disease, amyotrophic
             lateral sclerosis, multiple sclerosis, systemic lupus erythematosus, progressive
             supranuclear palsy, neurosyphilis, HIV (human immunodeficiency virus), learning
             disability, intellectual disability, hypoxic cerebral damage, or significant head
             trauma with loss of consciousness that led to persistent cognitive deficits.

          -  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's judgement.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 85 Years

Patient description (medical language): A 70-year-old man comes to the office accompanied by his wife.  The patient has experienced progressive memory loss over the last years.  He needs help with some of his routine activities, such as paying bills.  The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!"  Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus.  Family history includes Alzheimer disease in his father.  MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria.

Patient description (patient's own words): I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test.

Does the patient match the trial criteria? 1