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

  • STATUS
    Recruiting
  • End date
    Nov 2, 2023
  • participants needed
    1016
  • sponsor
    Hoffmann-La Roche
Updated on 19 September 2021
cognitive impairment
dementia
mini-mental state examination
alzheimer's disease
mild cognitive impairment
amyloid
amyloidosis
cognitive assessment

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 116. 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.

Details
Condition Dementia, Alzheimer's Disease, alzheimer, dementia alzheimer's type, Alzheimer Disease
Treatment Placebo, Gantenerumab
Clinical Study IdentifierNCT03444870
SponsorHoffmann-La Roche
Last Modified on19 September 2021

Eligibility

Yes No Not Sure

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

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 104 MRI scan
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