Alzheimer's DiseasePhase 3NCT05738486
A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)
A Phase 3 study testing Donanemab and Dexamethasone in people with Alzheimer's Disease and Dementia, run by Eli Lilly and Company at 49 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Alzheimer's Disease, Dementia, Brain Diseases
- What is being tested?
- Donanemab and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,175 participants
- Where
- 49 sitesin 2 countries
- Study dates
- 28 Feb 2023to May 2027
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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
Trial locations and contacts
49 sites in 2 countries.
49 sites in 2 countries
United States43 sites
JEM Research Institute
Atlantis, Florida, 33462
VIN-Julie Schwartzbard
Aventura, Florida, 33180
Gadolin Research
Beaumont, Texas, 77702
Northwest Clinical Research Center
Bellevue, Washington, 98007
Excel Medical Clinical Trials
Boca Raton, Florida, 33434
MD First Research - Chandler
Chandler, Arizona, 85286
K2 Medical Research
Clermont, Florida, 34711
Columbus Memory Center, LLC
Columbus, Georgia, 31909
Neurology Clinic, P.C.
Cordova, Tennessee, 38018
Kerwin Medical Center
Dallas, Texas, 75231
CenExel iResearch, LLC
Decatur, Georgia, 30030
Brain Matters Research
Delray Beach, Florida, 33445
Re:Cognition Health
Fairfax, Virginia, 22031
QUEST Research Institute
Farmington Hills, Michigan, 48334
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, 33912
Center for Advanced Research & Education
Gainesville, Georgia, 30501
Finlay Medical Research
Greenacres City, Florida, 33467
Infinity Clinical Research, LLC
Hollywood, Florida, 33024
The University of Texas Health Science Center at Houston
Houston, Texas, 77054
Irvine Clinical Research
Irvine, California, 92614
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Healthy Brain Clinic
Long Beach, California, 90804
ClinCloud - Maitland
Maitland, Florida, 32751
K2 Medical Research
Maitland, Florida, 32751
ClinCloud - Viera
Melbourne, Florida, 32940
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652
Renstar Medical Research
Ocala, Florida, 34470
Charter Research - Winter Park
Orlando, Florida, 32803
Progressive Medical Research
Port Orange, Florida, 32127
Butler Hospital
Providence, Rhode Island, 02906
CenExel iResearch, LLC
Savannah, Georgia, 31405
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, 91403
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, 07081
Alzheimer's Research and Treatment Center
Stuart, Florida, 34997
Universal Research Group
Tacoma, Washington, 98405
K2 Medical Research - Tampa
Tampa, Florida, 33607
K2 Summit Research
The Villages, Florida, 32159
Charter Research - Lady Lake
The Villages, Florida, 32162
MedVadis Research Corporation
Waltham, Massachusetts, 02451
Adams Clinical
Watertown, Massachusetts, 02472
Alzheimer's Research and Treatment Center
Wellington, Florida, 33414
Palm Beach Neurology
West Palm Beach, Florida, 33407
Conquest Research
Winter Park, Florida, 32789
United Kingdom6 sites
Re:Cognition Health - Birmingham
Birmingham, B16 8LT
Re:Cognition Health - Bristol
Bristol, Bristol, City of, BS32 4SY
Re:Cognition Health Guildford
Guildford, Reading, GU2 7YD
Re:Cognition Health - London
London, London, City of, W1G 9JF
Re:Cognition Health - Plymouth
Plymouth, PL6 8BT
Re:Cognition Health - Winchester
Winchester, Hampshire, SO21 1HU
About this study
Official title: Investigating the Effect of Different Donanemab Dosing Regimens on ARIA-E and Amyloid Lowering in Adults With Early Symptomatic Alzheimer's Disease
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.
- Conditions
- Alzheimer's Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Neurodegenerative Diseases
- Being tested
- Donanemab, Placebo, Dexamethasone
- Medical subject headings
- Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Neurodegenerative Diseases, Neurocognitive Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonanemabDrug
Also called LY3002813
Administered IV
PlaceboDrug
Administered IV
DexamethasoneDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| 1400 mg Donanemab - Standard Regimen | Experimental | Participants received:
* 700 milligrams (mg) donanemab administered intravenously (IV) at baseline, week 4, and 8.
* placebo administered IV at week 2, 6, 10, and 14.
* 1400 mg of donanemab administered IV at week 12, 16, 20, and 24.
Participants enrolled to addendum 3 will receive a single dose at least 12 months after their last dose Receives: Drug: Donanemab; Drug: Placebo |
| 1400 mg Donanemab - Dose Skipping | Experimental | Participants received:
* 700 mg donanemab administered IV at baseline.
* placebo administered IV at week 2, 4, 6, 10, and 14.
* 1400 mg of donanemab administered IV at week 8, 12, 16, 20, and 24.
Participants enrolled to addendum 3 will receive a single dose at least 12 months after their last dose Receives: Drug: Donanemab; Drug: Placebo |
| 1400 mg Donanemab - Titration | Experimental | Participants received:
* 350 mg donanemab administered IV at baseline.
* placebo administered IV at week 2, 6, 10, and 14.
* 700 mg donanemab administered IV at week 4.
* 1050 mg of donanemab administered IV at week 8.
* 1400 mg of donanemab administered IV at week 12, 16, 20, and 24.
Participants enrolled to addendum 3 will receive a single dose at least 12 months after their last dose Receives: Drug: Donanemab; Drug: Placebo |
| 1400 mg Donanemab - Maximum Concentration (Cmax) | Experimental | Participants received:
* 350 mg donanemab administered IV at baseline, weeks 2, 4, 6, 8, and 10.
* 700 mg donanemab administered IV at weeks 12 and 14.
* 1400 mg of donanemab administered IV at weeks 16, 20, and 24.
Participants enrolled to addendum 3 will receive a single dose at least 12 months after their last dose Receives: Drug: Donanemab; Drug: Placebo |
| Donanemab Addendum 2 Arm 1 | Experimental | Participants will receive donanemab by IV infusion.
Participants will receive placebo pretreatment to preserve the blind prior to donanemab infusion. Receives: Drug: Donanemab; Drug: Placebo |
| Donanemab Addendum 2 Arm 2 | Experimental | Participants will receive donanemab by IV infusion.
Participants will receive dexamethasone pretreatment prior to donanemab infusion Receives: Drug: Donanemab; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Any Occurrence of Amyloid-Related Imaging Abnormality-Edema/Effusion (ARIA-E)
Percentage of participants with occurrence of ARIA-E at Week 24 is reported here.
Measured: 24 Weeks
Secondary outcomes (7)
Percentage of Participants With Any Occurrence of ARIA-E
Outcome data will be provided after the study is completed.
Measured: 52 Weeks
Change From Baseline in Brain Amyloid Plaque Deposition As Measured By Amyloid Positron Emission Tomography (PET) Scan
Outcome data will be provided after the study is completed.
Measured: Baseline, 76 Weeks
Percentage of Participants With Any Occurrence of Amyloid-Related Imaging Abnormality-Hemorrhage/Hemosiderin Deposits (ARIA-H)
Percentage of participants with occurrence of ARIA-H at Week 24 is reported here.
Measured: 24 Weeks
Percentage of Participants With ARIA-H
Outcome data will be provided after the study is completed.
Measured: 52 Weeks
Percentage of Participants With Maximum Severity of ARIA-E or ARIA-H
Outcome data will be provided after the study is completed.
Measured: 76 Weeks
Pharmacokinetics (PK): Average Serum Concentration of Donanemab
Outcome data will be provided after the study is completed.
Measured: Baseline to 76 Weeks
Number of Participants With Anti-Drug Antibodies (ADAs) Against Donanemab, Including Treatment Emergent ADAs and Neutralizing Antibodies
Outcome data will be provided after the study is completed.
Measured: Baseline to End of Follow-Up (91 Weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start28 Feb 2023
- Primary completion16 May 2024
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 3b
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738486
- Sponsor's protocol ID
- 18648
- Other IDs
- I5T-MC-AACQ, 2022-502268-18-00, U1111-1285-9438
- Status last verified
- Oct 2025
- First submitted
- 13 Feb 2023
- Last updated
- 18 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Publications
Boustani M, Klein EG, Zimmer JA, Wang H, Engle SE, Phipps A, Japha M, Schilling T, Hartry A; Alzheimer's Disease Neuroimaging Initiative. Further data to address the Alzheimer's coverage with evidence development questions. Alzheimers Dement. 2026 Aug;22(8):e71724. doi: 10.1002/alz.71724.
PubMed 42552749Wang H, Nery ESM, Ardayfio P, Khanna R, Svaldi DO, Shcherbinin S, Xu W, Andersen SW, Hauck PM, Brooks DA, Collins EC, Salloway S, Mintun MA, Sims JR. The effect of modified donanemab titration on amyloid-related imaging abnormalities with edema/effusions and amyloid reduction: 18-month results from TRAILBLAZER-ALZ 6. J Prev Alzheimers Dis. 2025 Sep;12(8):100266. doi: 10.1016/j.tjpad.2025.100266. Epub 2025 Jul 5.
PubMed 40619285Wang H, Serap Monkul Nery E, Ardayfio P, Khanna R, Otero Svaldi D, Gueorguieva I, Shcherbinin S, Andersen SW, Hauck PM, Engle SE, Brooks DA, Collins EC, Fox NC, Greenberg SM, Salloway S, Mintun MA, Sims JR. Modified titration of donanemab reduces ARIA risk and maintains amyloid reduction. Alzheimers Dement. 2025 Apr;21(4):e70062. doi: 10.1002/alz.70062.
PubMed 40172303
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of Different Donanemab Dosing Regimens on ARIA-E and Amyloid Lowering in Adults With Early Symptomatic Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05738486
- Acronym / sponsor ID
- 18648
- Conditions
- Alzheimer's Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Neurodegenerative Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,175 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 16 May 2024 (actual)
- Study completion
- May 2027 (estimated)
- First posted
- 22 Feb 2023 (actual)
- Results
- Posted 14 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- Phase 3b
| Arm | Type | Receives |
|---|---|---|
| 1400 mg Donanemab - Standard Regimen | Experimental | Drug: Donanemab, Drug: PlaceboParticipants received: * 700 milligrams (mg) donanemab administered intravenously (IV) at baseline, week 4, and 8. * placebo administered IV at week 2, 6, 10, and 14. * 1400 mg of donanemab administered IV at week 12, 16, 20, and 24. Participants enrolled to addendum 3 will receive a single dose at least 12 months after their last dose |
| 1400 mg Donanemab - Dose Skipping | Experimental | Drug: Donanemab, Drug: PlaceboParticipants received: * 700 mg donanemab administered IV at baseline. * placebo administered IV at week 2, 4, 6, 10, and 14. * 1400 mg of donanemab administered IV at week 8, 12, 16, 20, and 24. Participants enrolled to addendum 3 will receive a single dose at least 12 months after their last dose |
| 1400 mg Donanemab - Titration | Experimental | Drug: Donanemab, Drug: PlaceboParticipants received: * 350 mg donanemab administered IV at baseline. * placebo administered IV at week 2, 6, 10, and 14. * 700 mg donanemab administered IV at week 4. * 1050 mg of donanemab administered IV at week 8. * 1400 mg of donanemab administered IV at week 12, 16, 20, and 24. Participants enrolled to addendum 3 will receive a single dose at least 12 months after their last dose |
| 1400 mg Donanemab - Maximum Concentration (Cmax) | Experimental | Drug: Donanemab, Drug: PlaceboParticipants received: * 350 mg donanemab administered IV at baseline, weeks 2, 4, 6, 8, and 10. * 700 mg donanemab administered IV at weeks 12 and 14. * 1400 mg of donanemab administered IV at weeks 16, 20, and 24. Participants enrolled to addendum 3 will receive a single dose at least 12 months after their last dose |
| Donanemab Addendum 2 Arm 1 | Experimental | Drug: Donanemab, Drug: PlaceboParticipants will receive donanemab by IV infusion. Participants will receive placebo pretreatment to preserve the blind prior to donanemab infusion. |
| Donanemab Addendum 2 Arm 2 | Experimental | Drug: Donanemab, Drug: DexamethasoneParticipants will receive donanemab by IV infusion. Participants will receive dexamethasone pretreatment prior to donanemab infusion |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DonanemabAlso: LY3002813Administered IV | Drug | 1400 mg Donanemab - Dose Skipping, 1400 mg Donanemab - Maximum Concentration (Cmax), 1400 mg Donanemab - Standard Regimen, 1400 mg Donanemab - Titration, Donanemab Addendum 2 Arm 1, Donanemab Addendum 2 Arm 2 |
| PlaceboAdministered IV | Drug | 1400 mg Donanemab - Dose Skipping, 1400 mg Donanemab - Maximum Concentration (Cmax), 1400 mg Donanemab - Standard Regimen, 1400 mg Donanemab - Titration, Donanemab Addendum 2 Arm 1 |
| DexamethasoneAdministered IV | Drug | Donanemab Addendum 2 Arm 2 |
Primary outcome
Percentage of Participants With Any Occurrence of Amyloid-Related Imaging Abnormality-Edema/Effusion (ARIA-E)
Time frame: 24 Weeks
Percentage of participants with occurrence of ARIA-E at Week 24 is reported here.
7 secondary outcomes
Percentage of Participants With Any Occurrence of ARIA-E
Time frame: 52 Weeks
Change From Baseline in Brain Amyloid Plaque Deposition As Measured By Amyloid Positron Emission Tomography (PET) Scan
Time frame: Baseline, 76 Weeks
Percentage of Participants With Any Occurrence of Amyloid-Related Imaging Abnormality-Hemorrhage/Hemosiderin Deposits (ARIA-H)
Time frame: 24 Weeks
Percentage of Participants With ARIA-H
Time frame: 52 Weeks
Percentage of Participants With Maximum Severity of ARIA-E or ARIA-H
Time frame: 76 Weeks
Pharmacokinetics (PK): Average Serum Concentration of Donanemab
Time frame: Baseline to 76 Weeks
Number of Participants With Anti-Drug Antibodies (ADAs) Against Donanemab, Including Treatment Emergent ADAs and Neutralizing Antibodies
Time frame: Baseline to End of Follow-Up (91 Weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42552749Boustani M, Klein EG, Zimmer JA, Wang H, Engle SE, Phipps A, Japha M, Schilling T, Hartry A; Alzheimer's Disease Neuroimaging Initiative. Further data to address the Alzheimer's coverage with evidence development questions. Alzheimers Dement. 2026 Aug;22(8):e71724. doi: 10.1002/alz.71724.
- Derived from this study: PubMed 40619285Wang H, Nery ESM, Ardayfio P, Khanna R, Svaldi DO, Shcherbinin S, Xu W, Andersen SW, Hauck PM, Brooks DA, Collins EC, Salloway S, Mintun MA, Sims JR. The effect of modified donanemab titration on amyloid-related imaging abnormalities with edema/effusions and amyloid reduction: 18-month results from TRAILBLAZER-ALZ 6. J Prev Alzheimers Dis. 2025 Sep;12(8):100266. doi: 10.1016/j.tjpad.2025.100266. Epub 2025 Jul 5.
- Derived from this study: PubMed 40172303Wang H, Serap Monkul Nery E, Ardayfio P, Khanna R, Otero Svaldi D, Gueorguieva I, Shcherbinin S, Andersen SW, Hauck PM, Engle SE, Brooks DA, Collins EC, Fox NC, Greenberg SM, Salloway S, Mintun MA, Sims JR. Modified titration of donanemab reduces ARIA risk and maintains amyloid reduction. Alzheimers Dement. 2025 Apr;21(4):e70062. doi: 10.1002/alz.70062.
- A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
49 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Donanemab and Dexamethasone in people with Alzheimer's Disease and Dementia, run by Eli Lilly and Company at 49 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Any Occurrence of Amyloid-Related Imaging Abnormality-Edema/Effusion (ARIA-E) (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05738486, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.