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Status:

TERMINATED

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

Lead Sponsor:

Hoffmann-La Roche

Conditions:

Alzheimer Disease

Eligibility:

All Genders

50-90 years

Phase:

PHASE3

Brief Summary

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 part...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    June 6 2018

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 17 2023

    Estimated Enrollment :

    1053 Patients enrolled

    Trial Details

    Trial ID

    NCT03444870

    Start Date

    June 6 2018

    End Date

    February 17 2023

    Last Update

    January 30 2024

    Active Locations (172)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 43 (172 locations)

    1

    Center for Neurosciences

    Tucson, Arizona, United States, 85718

    2

    Global Clinical Trials; Irvine, CA

    Irvine, California, United States, 92614

    3

    Sutter Medical Group, Neurology

    Sacramento, California, United States, 95816

    4

    Syrentis Clinical Research

    Santa Ana, California, United States, 92705