The purpose of this study is to assess the efficacy and safety of trontinemab in participants with early symptomatic Alzheimer's disease (AD) (mild cognitive impairment \[MCI\] to mild dementia due to AD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
800
Participants will receive IV trontinemab
Participants will receive IV placebo
Change from baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)
Time frame: Baseline - Week 72
Change from baseline through Week 72 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13)
Time frame: Baseline - Week 72
Change from baseline through Week 72 in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) total score and instrumental score
Time frame: Baseline - Week 72
Change from baseline through Week 72 in Integrated Alzheimer's Disease Rating Scale (iADRS)
Time frame: Baseline - Week 72
Change from baseline through Week 72 in Mini-Mental State Examination (MMSE)
Time frame: Baseline - Week 72
Change from baseline in CDR-SB
Time frame: Baseline up to but excluding Week 72
Time to increase in Clinical Dementia Rating, Global Score (CDR-GS)
Time frame: Baseline - Week 72
Percentage of participants with adverse events (AEs)
Time frame: Baseline - Week 72
Percentage of participants with amyloid-related imaging abnormalities (ARIA) magnetic resonance imaging (MRI) findings
Time frame: Baseline - Week 72
Percentage of participants with infusion-related reactions (IRR)
Time frame: Baseline - Week 72
Reference Study ID Number: WN45447 https://forpatients.roche.com/
CONTACT
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Banner Alzheimer?s Institute
Phoenix, Arizona, United States
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Long Beach, California, United States
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Oakland, California, United States
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Riverside, California, United States
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Sherman Oaks, California, United States
RECRUITINGJEM Research LLC
Atlantis, Florida, United States
RECRUITINGK2 Medical Research-Winter Garden
Clermont, Florida, United States
RECRUITINGVisionary Investigators Network- Neurology Aventura
Miami, Florida, United States
RECRUITINGCharter Research - Winter Park/Orlando
Orlando, Florida, United States
RECRUITINGConquest Research - Lake Nona
Orlando, Florida, United States
RECRUITING...and 94 more locations
Percentage of participants with anti-drug antibodies (ADAs) to trontinemab
Time frame: Baseline - Week 72
Change from baseline through Week 72 in brain amyloid load as measured by amyloid positron emission tomography (PET) scan
Time frame: Baseline - Week 72
Change from baseline to Week 72 in brain tau load as measured by tau PET scan in a subset of participants
Time frame: Baseline - Week 72
Change from baseline through Week 72 in cerebrospinal fluid (CSF) biomarkers of disease p-tau181, neurogranin, Aβ42 in a subset of participants
Time frame: Baseline - Week 72
Change from baseline through Week 72 in blood biomarkers p-tau217, glial fibrillar acidic protein (GFAP)
Time frame: Baseline - Week 72