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
HonorHealth Research Institute
Scottsdale, Arizona, United States
Profound Research LLC
Carlsbad, California, United States
Irvine Clinical Research
Irvine, California, United States
UCSD - Altman Clinical and Translational Research Institute (ACTRI)
La Jolla, California, United States
Stanford Neuroscience Health Center
Palo Alto, California, United States
CenExel Rocky Mountain Clinical Research
Englewood, Colorado, United States
Ki Health Partners, LLc, dba New England Institute for Clinical Research
Stamford, Connecticut, United States
JEM Research Institute
Atlantis, Florida, United States
VIN - Aventura
Aventura, Florida, United States
...and 60 more locations