Summary

for people ages 50-90 (full criteria)
at UCLA
study started
estimated completion

Description

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 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.

Official Title

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy, and Safety Study of Gantenerumab in Patients With Early (Prodromal to Mild) Alzheimer's Disease

Keywords

Alzheimer's Disease Alzheimer Disease Antibodies, Monoclonal Gantenerumab

Eligibility

For people ages 50-90

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
  • Uncontrolled hypertension

Locations

  • UCLA - School of Medicine, VA Medical Center not yet accepting patients
    Los Angeles California 90073 United States
  • Irvine Center for Clinical Research accepting new patients
    Irvine California 92614 United States
  • San Francisco Clinical Research Center withdrawn
    San Francisco California 94109 United States
  • Pacific Research Network - PRN terminated
    San Diego California 92103 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
Links
US residents may click here to find out more about participation in this study
ID
NCT03443973
Phase
Phase 3
Study Type
Interventional
Last Updated