A Study to Evaluate the Safety and Effectiveness of Gantenerumab in Participants With Early Alzheimer's Disease (AD)


About this study

The purpose of this study is to evaluate the effectiveness and safety of gantenerumab versus placebo in participants with early (prodromal to mild) Alzheimer's Disease (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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Bryan Woodruff, M.D.

Closed for enrollment

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