Clinical trial: Efficacy and Safety Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD) (NCT03444870)

Eligibility criteria:
Key Inclusion criteria:

          -  Meets National Institute on Aging/Alzheimer's Association (NIAAA) core clinical
             criteria for probable AD dementia or prodromal AD (consistent with the NIAAA
             diagnostic criteria and guidelines for mild cognitive impairment)

          -  Evidence of the AD pathological process, as confirmed by CSF tau/A-beta42or amyloid
             PET scan

          -  Demonstrated abnormal memory function

          -  MMSE score greater than or equal to 22 (≥ 22)

          -  Clinical dementia rating-global score (CDR-GS) of 0.5 or 1.0

          -  Availability of a reliable study partner who accepts to participate in study
             procedures throughout the 2 years duration of study

          -  If receiving symptomatic AD medications, the dosing regimen must have been stable for
             3 months prior to screening and until randomization

          -  For enrollment in the China extension, patients must have residence in mainland China,
             Hong Kong, or Taiwan and be of Chinese ancestry

          -  For women of childbearing potential: agreement to remain abstinent (refrain from
             heterosexual intercourse) or use contraceptive methods

        Key Exclusion criteria:

          -  Any evidence of a condition other than AD that may affect cognition

          -  History of schizophrenia, schizoaffective disorder, major depression, or bipolar
             disorder

          -  History or presence of clinically evident systemic vascular disease that in the
             opinion of the investigator has the potential to affect cognitive function

          -  History or presence of clinically evident cerebrovascular disease

          -  History or presence of posterior reversible encephalopathy syndrome

          -  History or presence of any stroke with clinical symptoms within the past 12 months, or
             documented history within the last 6 months of an acute event that is consistent with
             a transient ischemic attack

          -  History of severe, clinically significant CNS trauma

          -  History or presence of intracranial mass (e.g., glioma, meningioma) that could
             potentially impair cognition

          -  Presence of infections that affect brain function or history of infections that
             resulted in neurologic sequelae

          -  History or presence of systemic autoimmune disorders that potentially cause
             progressive neurologic disease with associated cognitive deficits

          -  At risk for suicide in the opinion of the investigator

          -  Alcohol and/or substance abuse or dependants in past 2 years

          -  Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities

          -  Any contraindications to brain MRI

          -  Unstable or clinically significant cardiovascular, kidney or liver disease

          -  Uncontrolled hypertension

          -  Unstable or clinically significant cardiovascular disease

          -  Abnormal thyroid function

          -  Patients with evidence of folic acid deficiency

        Exclusion for Open-Label Extension (OLE):

          -  Discontinued from study treatment during the double-blind treatment period

          -  Received any other investigational medication during the double-blind treatment period
             or after the end of double-blind treatment

          -  Participation in the OLE deemed inappropriate by the investigator

          -  Presence of ARIA-E findings at the Week 104 MRI scan
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 90 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? Entailment