A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)
- Conditions
- Alzheimer's DiseaseDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders
- Interventions
- Registration Number
- NCT05738486
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
This study will investigate different donanemab dosing regimens and their effect on the frequency and severity of ARIA-E in adults with early symptomatic Alzheimer's disease (AD) and explore participant characteristics that might predict risk of ARIA.
Approximately 300 additional participants will be enrolled per addendum.
The study will last approximately 91 weeks and include up to 26 visits in the main study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1100
- Gradual and progressive change in memory function reported by the participant or informant for ≥6 months.
- A mini mental state examination (MMSE) score of 20 to 28 (inclusive) at screening.
- Have an amyloid PET scan result from central read, consistent with the presence of amyloid pathology.
- Have significant neurological disease affecting the central nervous system other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures, except febrile childhood seizures.
- Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study.
- A life expectancy of <24 months.
- Contraindication to MRI or PET scans
- Have had prior treatment with a passive anti-amyloid immunotherapy.
- Have a presence or history of malignant neoplasms within the past 5 years prior to Visit 1.
Exceptions:
- non-metastatic basal- or squamous-cell skin cancer
- Stage 0 non-invasive carcinoma of the cervix
- Stage 0 non-invasive prostate cancer, or
- other cancers with low risk of recurrence or spread
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Donanemab Dose Level 1 Donanemab Participants will receive donanemab by intravenously (IV) infusion. Participants will receive placebo at certain intervals to preserve the blind. Donanemab Dose Level 1 Placebo Participants will receive donanemab by intravenously (IV) infusion. Participants will receive placebo at certain intervals to preserve the blind. Donanemab Dose Level 2 Donanemab Participants will receive donanemab by IV infusion. Participants will receive placebo at certain intervals to preserve the blind. Donanemab Dose Level 2 Placebo Participants will receive donanemab by IV infusion. Participants will receive placebo at certain intervals to preserve the blind. Donanemab Dose Level 3 Donanemab Participants will receive donanemab by IV infusion. Participants will receive placebo at certain intervals to preserve the blind. Donanemab Dose Level 3 Placebo Participants will receive donanemab by IV infusion. Participants will receive placebo at certain intervals to preserve the blind. Donanemab Dose Level 4 Donanemab Participants will receive donanemab by IV infusion. Participants will receive placebo at certain intervals to preserve the blind. Donanemab Dose Level 4 Placebo Participants will receive donanemab by IV infusion. Participants will receive placebo at certain intervals to preserve the blind. Donanemab Addendum Arm 1 Donanemab Participants will receive donanemab by IV infusion. Participants will receive placebo pretreatment to preserve the blind prior to donanemab infusion. Donanemab Addendum Arm 1 Placebo Participants will receive donanemab by IV infusion. Participants will receive placebo pretreatment to preserve the blind prior to donanemab infusion. Donanemab Addendum Arm 2 Donanemab Participants will receive donanemab by IV infusion. Participants will receive dexamethasone pretreatment prior to donanemab infusion Donanemab Addendum Arm 2 Dexamethasone Participants will receive donanemab by IV infusion. Participants will receive dexamethasone pretreatment prior to donanemab infusion
- Primary Outcome Measures
Name Time Method Percentage of Participants with Any Occurrence of Amyloid-Related Imaging Abnormality-Edema/Effusion (ARIA-E) 24 Weeks
- Secondary Outcome Measures
Name Time Method Number of Participants with Anti-Drug Antibodies (ADAs) Against Donanemab, including Treatment Emergent ADAs and Neutralizing Antibodies Baseline to End of Follow-Up (91 Weeks) Percentage of Participants with Any Occurrence of ARIA-E 52 Weeks Change from Baseline in Brain Amyloid Plaque Deposition As Measured By Amyloid Positron Emission Tomography (PET) Scan Baseline, 76 Weeks Percentage of Participants with Any Occurrence of Amyloid-Related Imaging Abnormality-Hemorrhage/Hemosiderin Deposits (ARIA-H) 24 Weeks Percentage of Participants with ARIA-H 52 Weeks Percentage of Participants with Maximum Severity of ARIA-E or ARIA-H 52 Weeks Pharmacokinetics (PK): Average Serum Concentration of Donanemab Baseline to 52 Weeks
Trial Locations
- Locations (46)
Irvine Clinical Research
🇺🇸Irvine, California, United States
Neuropsychiatric Research Center of Southwest Florida
🇺🇸Fort Myers, Florida, United States
Palm Beach Neurology
🇺🇸West Palm Beach, Florida, United States
Conquest Research
🇺🇸Winter Park, Florida, United States
CenExel iResearch, LLC
🇺🇸Savannah, Georgia, United States
Kerwin Medical Center
🇺🇸Dallas, Texas, United States
Columbus Memory Center, LLC
🇺🇸Columbus, Georgia, United States
Center for Advanced Research & Education
🇺🇸Gainesville, Georgia, United States
MD First Research - Chandler
🇺🇸Chandler, Arizona, United States
JEM Research Institute
🇺🇸Atlantis, Florida, United States
Excel Medical Clinical Trials
🇺🇸Boca Raton, Florida, United States
Finlay Medical Research
🇺🇸Greenacres City, Florida, United States
ClinCloud - Viera
🇺🇸Melbourne, Florida, United States
ClinCloud - Maitland
🇺🇸Maitland, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Suncoast Clinical Research, Inc.
🇺🇸New Port Richey, Florida, United States
Progressive Medical Research
🇺🇸Port Orange, Florida, United States
Charter Research - Lady Lake
🇺🇸The Villages, Florida, United States
K2 Summit Research
🇺🇸The Villages, Florida, United States
Alzheimer's Research and Treatment Center
🇺🇸Wellington, Florida, United States
MedVadis Research Corporation
🇺🇸Waltham, Massachusetts, United States
Butler Hospital
🇺🇸Providence, Rhode Island, United States
The Cognitive and Research Center of New Jersey
🇺🇸Springfield, New Jersey, United States
QUEST Research Institute
🇺🇸Farmington Hills, Michigan, United States
Re:Cognition Health
🇺🇸Fairfax, Virginia, United States
Neurology Clinic, P.C.
🇺🇸Cordova, Tennessee, United States
Universal Research Group
🇺🇸Tacoma, Washington, United States
Re:Cognition Health - Bristol
🇬🇧Bristol, Bristol, City Of, United Kingdom
Re:Cognition Health - Winchester
🇬🇧Winchester, Hampshire, United Kingdom
Re:Cognition Health Guildford
🇬🇧Guildford, Reading, United Kingdom
Re:Cognition Health - Birmingham
🇬🇧Birmingham, United Kingdom
Re:Cognition Health - London
🇬🇧London, London, City Of, United Kingdom
Re:Cognition Health - Plymouth
🇬🇧Plymouth, United Kingdom
Adams Clinical
🇺🇸Watertown, Massachusetts, United States
VIN-Julie Schwartzbard
🇺🇸Aventura, Florida, United States
Infinity Clinical Research, LLC
🇺🇸Hollywood, Florida, United States
Brain Matters Research
🇺🇸Delray Beach, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
Gadolin Research
🇺🇸Beaumont, Texas, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
California Neuroscience Research Medical Group, Inc.
🇺🇸Sherman Oaks, California, United States
Healthy Brain Clinic
🇺🇸Long Beach, California, United States
K2 Medical Research
🇺🇸Maitland, Florida, United States
Charter Research - Winter Park
🇺🇸Orlando, Florida, United States
K2 Medical Research - Tampa
🇺🇸Tampa, Florida, United States