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

Purpose

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.

Condition

  • Alzheimer Disease

Eligibility

Eligible Ages
Between 50 Years and 90 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Gantenerumab
Gantenerumab will be administered as SC injections with gradual uptitration.
  • Drug: Gantenerumab
    Gantenerumab will be administered as per the schedule specified in the respective arm.
    Other names:
    • RO4909832
Placebo Comparator
Placebo
Placebo will be administered as SC injections with gradual uptitration.
  • Drug: Placebo
    Placebo will be administered as per the schedule specified in the respective arm.

Recruiting Locations

More Details

NCT ID
NCT03444870
Status
Recruiting
Sponsor
Hoffmann-La Roche

Study Contact

Reference Study ID Number: WN29922 www.roche.com/about_roche/roche_worldwide.htm
888-662-6728 (U.S. and Canada)
Global-Roche-Genentech-Trials@gene.com