Last updated on July 2019

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


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Alzheimer's Disease
  • Age: Between 50 - 90 Years
  • Gender: Male or Female

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 or 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 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
  • Uncontrolled hypertension

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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