The main purpose of this study is to evaluate whether treatment with donanemab slows the progression of cognitive (how we think, learn, remember, pay attention, and make decisions) and functional (how we are able to perform daily activities) decline. For each participant, the study will last one and a half years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
350
Change from Baseline on Clinical Dementia Rating - Sum of Boxes (CDR-SB)
Time frame: Baseline through Week 52
Change from Baseline for Integrated Alzheimer's Disease Rating Scale (iADRS)
Time frame: Baseline through Week 52
Change from Baseline for Alzheimer's Disease Assessment Scale - Cognitive Subscale, 13 items (ADAS-Cog13)
Time frame: Baseline through Week 52
Change from Baseline for Alzheimer's Disease Cooperative Study - Instrumental Activities of Daily Living Inventory (ADCS-iADL)
Time frame: Baseline through Week 52
Time to Clinical Progression of Dementia as Measured by Clinical Dementia Rating - Global Score (CDR-GS)
Time frame: Baseline through Week 52
Change from Baseline in Brain Amyloid Plaque Levels
Time frame: Baseline through Week 52
Trough Concentration at Steady State
Time frame: Baseline through Week 52
Maximum Concentration at Steady State
Time frame: Baseline through Week 52
Antidrug Antibodies (ADA) Against Donanemab
Time frame: Baseline through Week 52
Frequency of Neutralizing Antibodies to Donanemab Treatment-Emergent ADA-Positive Participants
Time frame: Baseline through Week 52
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
TrialSphere Corp
Chandler, Arizona, United States
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Scottsdale, Arizona, United States
NOT_YET_RECRUITINGProfound Research LLC
Carlsbad, California, United States
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Irvine, California, United States
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La Jolla, California, United States
NOT_YET_RECRUITINGStanford Neuroscience Health Center
Palo Alto, California, United States
NOT_YET_RECRUITINGCenExel Rocky Mountain Clinical Research
Englewood, Colorado, United States
NOT_YET_RECRUITINGKi Health Partners, LLc, dba New England Institute for Clinical Research
Stamford, Connecticut, United States
RECRUITINGJEM Research Institute
Atlantis, Florida, United States
RECRUITINGVIN - Aventura
Aventura, Florida, United States
RECRUITING...and 62 more locations