NCT05738486Active, not recruitingPhase 3
A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)
Investigating the Effect of Different Donanemab Dosing Regimens on ARIA-E and Amyloid Lowering in Adults With Early Symptomatic Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 18 Jun 2026
Brief summary (registry, in English)
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 375 additional participants will be enrolled in addendum 2. Addendum 3 includes a subset of participants from the main study to receive a single dose. The study will last approximately 91 weeks and include up to 26 visits in the main study.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1175 (actual)
- First submitted
- 13 Feb 2023
- Start date
- 28 Feb 2023
- Primary completion date
- 16 May 2024
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Alzheimer disease
- NCT number
- NCT05738486
- EU CT number
- 2022-502268-18-00
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 1175
- From 28 Feb 2023 to the primary completion date, 16 May 2024
- 49 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have had prior treatment with a passive anti-amyloid immunotherapy.
Other illness
- 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.
- 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 prostate cancer, or
- other cancers with low risk of recurrence or spread
Other
- A life expectancy of \<24 months.
- Contraindication to MRI or PET scans
- Stage 0 non-invasive carcinoma of the cervix
Who the study is looking for
- 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.
Age in the registry: 60 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (49)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Re:Cognition Health - Birmingham Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Re:Cognition Health - Bristol Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| Re:Cognition Health - Guildford Coordinator of this site? Confirm its status | Guildford | United Kingdom | Unknown status |
| Re:Cognition Health - London Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Re:Cognition Health - Plymouth Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Unknown status |
| Re:Cognition Health - Winchester Coordinator of this site? Confirm its status | Winchester | United Kingdom | Unknown status |
| JEM Research Institute Coordinator of this site? Confirm its status | Atlantis | United States | Unknown status |
| VIN-Julie Schwartzbard Coordinator of this site? Confirm its status | Aventura | United States | Unknown status |
| Gadolin Research Coordinator of this site? Confirm its status | Beaumont | United States | Unknown status |
| Northwest Clinical Research Center Coordinator of this site? Confirm its status | Bellevue | United States | Unknown status |
| Excel Medical Clinical Trials Coordinator of this site? Confirm its status | Boca Raton | United States | Unknown status |
| MD First Research - Chandler Coordinator of this site? Confirm its status | Chandler | United States | Unknown status |
| K2 Medical Research Coordinator of this site? Confirm its status | Clermont | United States | Unknown status |
| Columbus Memory Center, LLC Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| Neurology Clinic, P.C. Coordinator of this site? Confirm its status | Cordova | United States | Unknown status |
| Kerwin Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| CenExel iResearch, LLC Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| Brain Matters Research Coordinator of this site? Confirm its status | Delray Beach | United States | Unknown status |
| Re:Cognition Health Coordinator of this site? Confirm its status | Fairfax | United States | Unknown status |
| QUEST Research Institute Coordinator of this site? Confirm its status | Farmington Hills | United States | Unknown status |
| Neuropsychiatric Research Center of Southwest Florida Coordinator of this site? Confirm its status | Fort Myers | United States | Unknown status |
| Center for Advanced Research & Education Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Finlay Medical Research Coordinator of this site? Confirm its status | Greenacres City | United States | Unknown status |
| Infinity Clinical Research, LLC Coordinator of this site? Confirm its status | Hollywood | United States | Unknown status |
| The University of Texas Health Science Center at Houston Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Irvine Clinical Research Coordinator of this site? Confirm its status | Irvine | United States | Unknown status |
| Jacksonville Center for Clinical Research Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Healthy Brain Clinic Coordinator of this site? Confirm its status | Long Beach | United States | Unknown status |
| K2 Medical Research Coordinator of this site? Confirm its status | Maitland | United States | Unknown status |
| ClinCloud - Maitland Coordinator of this site? Confirm its status | Maitland | United States | Unknown status |
| ClinCloud - Viera Coordinator of this site? Confirm its status | Melbourne | United States | Unknown status |
| Suncoast Clinical Research, Inc. Coordinator of this site? Confirm its status | New Port Richey | United States | Unknown status |
| Renstar Medical Research Coordinator of this site? Confirm its status | Ocala | United States | Unknown status |
| Charter Research - Winter Park Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Progressive Medical Research Coordinator of this site? Confirm its status | Port Orange | United States | Unknown status |
| Butler Hospital Coordinator of this site? Confirm its status | Providence | United States | Unknown status |
| CenExel iResearch, LLC Coordinator of this site? Confirm its status | Savannah | United States | Unknown status |
| California Neuroscience Research Medical Group, Inc. Coordinator of this site? Confirm its status | Sherman Oaks | United States | Unknown status |
| The Cognitive and Research Center of New Jersey Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Alzheimer's Research and Treatment Center Coordinator of this site? Confirm its status | Stuart | United States | Unknown status |
| Universal Research Group Coordinator of this site? Confirm its status | Tacoma | United States | Unknown status |
| K2 Medical Research - Tampa Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Charter Research - Lady Lake Coordinator of this site? Confirm its status | The Villages | United States | Unknown status |
| K2 Summit Research Coordinator of this site? Confirm its status | The Villages | United States | Unknown status |
| MedVadis Research Corporation Coordinator of this site? Confirm its status | Waltham | United States | Unknown status |
| Adams Clinical Coordinator of this site? Confirm its status | Watertown | United States | Unknown status |
| Alzheimer's Research and Treatment Center Coordinator of this site? Confirm its status | Wellington | United States | Unknown status |
| Palm Beach Neurology Coordinator of this site? Confirm its status | West Palm Beach | United States | Unknown status |
| Conquest Research Coordinator of this site? Confirm its status | Winter Park | United States | Unknown status |
Related publications
- Further data to address the Alzheimer's coverage with evidence development questions.Alzheimers Dement · 2026 · PMID 42552749
This page is information, not medical advice. Discuss any trial with your doctor.