A Study of Remternetug (LY3372993) in Participants With Alzheimer's Disease (TRAILRUNNER-ALZ 1)
Alzheimer's Disease
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring Mild cognitive impairment, Alzheimer's disease, Dementia, Amyloid-beta therapy, Amyloid Plaque, Disease modifying
Eligibility Criteria
Inclusion Criteria:
- Gradual and progressive change in cognitive function ≥6 months prior to screening.
- A Mini-Mental (MMSE) score of 20 to 28 (inclusive) at screening.
- Has a P-tau result consistent with the presence of amyloid pathology.
- Has an amyloid PET scan result consistent with the presence of brain amyloid pathology.
- Have a reliable study partner who will provide written informed consent to participate and is in frequent contact with the participant.
- Have adequate literacy, vision, and hearing for the neuropsychological testing in the opinion of the investigator at the time of screening.
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
- Males and females will be eligible for this study.
- Women not of childbearing potential (WNOCBP) may participate in this trial.
Exclusion Criteria:
- Significant neurological disease affecting the central nervous system (CNS) other than AD, that may affect cognition or ability to complete the study.
- Current serious or unstable illnesses that, in the investigator's opinion, could interfere with the analyses in this study; or has a life expectancy of <24 months.
- History of cancer with high risk of recurrence and preventing completion of the trial.
- Participants with any current primary psychiatric diagnosis other than AD that in the investigator's opinion, is likely to confound interpretation of the drug effect, affect cognitive assessment, or affect the participant's ability to complete the study.
- History of of clinically significant multiple or severe drug allergies.
- Have any clinically important abnormality at screening, as determined by investigator that could be detrimental to the participant, could compromise the study, or show evidence of other etiologies for dementia.
- Screening magnetic resonance imaging (MRI) which shows evidence of significant abnormality that would suggest another potential etiology for progressive dementia or a clinically significant finding that may impact the participant's ability to safely participate in the study.
- Have any contraindications for MRI or positron emission tomography (PET).
- Have had prior treatment with a passive anti-amyloid immunotherapy that is <5 half-lives prior to randomization.
- Have received active immunization against Aβ in any other study.
- Have known allergies to remternetug related compounds, or any components of the formulation.
Sites / Locations
- MD First Research - ChandlerRecruiting
- Hope Clinical Research, Inc.Recruiting
- North County Neurology AssociatesRecruiting
- Wr- Pri, LlcRecruiting
- Neuro-Pain Medical CenterRecruiting
- Irvine Clinical ResearchRecruiting
- Kaizen Brain CenterRecruiting
- Anderson Clinical ResearchRecruiting
- Mountain Neurological Research CenterRecruiting
- Alpine Clinical Research CenterRecruiting
- Colorado Springs Neurological AssociatesRecruiting
- Ki Health Partners, LLc, dba New England Institute for Clinical ResearchRecruiting
- JEM Research InstituteRecruiting
- VIN-Julie SchwartzbardRecruiting
- Brain Matters ResearchRecruiting
- Neuropsychiatric Research Center of Southwest FloridaRecruiting
- Finlay Medical ResearchRecruiting
- Encore Research Group- Jacksonville Center for Clinical ResearchRecruiting
- Charter Research - Lady LakeRecruiting
- ClinCloud - MaitlandRecruiting
- K2 Medical ResearchRecruiting
- ClinCloud - VieraRecruiting
- Merritt Island Medical Research, LLCRecruiting
- VIN-Andrew LermanRecruiting
- Optimus U CorporationRecruiting
- Suncoast Clinical Research, Inc.Recruiting
- Renstar Medical ResearchRecruiting
- Emerald Coast Neurology - Airport BoulevardRecruiting
- Progressive Medical ResearchRecruiting
- Alzheimer's Research and Treatment CenterRecruiting
- Brain Matters ResearchRecruiting
- Tallahassee Neurological ClinicRecruiting
- Palm Beach NeurologyRecruiting
- Conquest ResearchRecruiting
- Charter Research - Winter ParkRecruiting
- Columbus Memory Center, PCRecruiting
- CenExel iResearch, LLCRecruiting
- Great Lakes Clinical Trials - AndersonvilleRecruiting
- AMITA Health - Alexian Brothers Neurosciences Institute Clinical ResearchRecruiting
- Cotton O'Neil Clinical Research Center - Central OfficeRecruiting
- Care Access - Lake CharlesRecruiting
- MedVadis Research CorporationRecruiting
- Adams ClinicalRecruiting
- Covenant Medical CenterRecruiting
- Citizens Memorial Hospital DistrictRecruiting
- Clinical Research ProfessionalsRecruiting
- Las Vegas Medical ResearchRecruiting
- The Cognitive and Research Center of New JerseyRecruiting
- Advanced Memory Research Institute of New JerseyRecruiting
- Neurological Associates AlbanyRecruiting
- AMC ResearchRecruiting
- Carteret Medical GroupRecruiting
- NeuroScience Research CenterRecruiting
- Valley Medical ResearchRecruiting
- Neurology Diagnostics, Inc.Recruiting
- Center for Cognitive HealthRecruiting
- The Clinical Trial Center, LLCRecruiting
- Keystone Clinical StudiesRecruiting
- Rhode Island Mood & Memory Research InstituteRecruiting
- Neurology Clinic, P.C.Recruiting
- Texas Diabetes & Endocrinology, P.A.Recruiting
- Gadolin ResearchRecruiting
- Kerwin Medical CenterRecruiting
- Neurology Consultants of Dallas, PARecruiting
- Central Texas Neurology ConsultantsRecruiting
- Consano Clinical Research, LLCRecruiting
- The University of Texas Health Science Center at HoustonRecruiting
- Re:Cognition HealthRecruiting
- National Clinical Research, IncRecruiting
- Northwest Clinical Research CenterRecruiting
- Universal Research GroupRecruiting
- Memory Clinic TorideRecruiting
- Katayama Medical Clinic
- Memory Clinic OchanomizuRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Placebo Comparator
Experimental
Experimental
Remternetug (IV)
Remternetug (SC)
Placebo
Open-Label Addenda Remternetug (IV)
Open-Label Addenda Remternetug (SC)
Participants will receive remternetug intravenously (IV) Participants will receive remternetug IV during the treatment period, then switch to placebo IV in the extension period.
Participants will receive one of two dosing regimens of remternetug subcutaneously (SC) Participants will receive remternetug SC during the treatment period, then switch to placebo SC in the extension period.
Participants will receive placebo matching remternetug IV or SC. Participants will receive placebo IV during the treatment period, then switch to remternetug IV in the extension period. Participants will receive placebo SC during the treatment period, then switch to LY3372993 SC in the extension period.
Participants will receive one of three dosing regimens of remternetug IV during the open-label addenda.
Participants will receive one of two dosing regimens of remternetug SC during the open-label addenda.