Efficacy and Safety Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD) | NCT03444870 | Trialant

Efficacy and Safety Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD) | NCT03444870 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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 116 MRI scan