Safety and Efficacy Study of Gantenerumab in Participants With Early Alzheimer's Disease (AD)
- Study HIC#:2000021691
- Last Updated:07/15/2021
This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of gantenerumab versus placebo in participants with early (prodromal to mild) AD. All participants must show evidence of beta-amyloid pathology. Eligible participants will be randomized 1:1 to receive either subcutaneous (SC) injection of gantenerumab or placebo. The primary efficacy assessment will be performed at the end of the double blind period at week 104. Participants will then be offered to enter into an open-label extension (OLE). Participants not willing to go to the OLE will participate in a long term follow-up period for up to 50 weeks after the last gantenerumab dose.
- Age50 years - 90 years
- Start Date01/04/2019
- End Date05/31/2022
Trial Purpose and Description
This study will evaluate the efficacy and safety of gantenerumab compared with placebo in patients with prodromal to mild AD. Specific objectives and corresponding endpoints for the study are outlined in the following table.
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 [MCI])
Evidence of the AD pathological process, as confirmed by CSF or amyloid PET scan
Demonstrated abnormal memory function
MMSE score great 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 baseline 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.
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
At risk for suicide in the opinion of the investigator
Patients with evidence of folic acid deficiency
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