A Study of Remternetug (LY3372993) in Participants With Alzheimer's Disease (TRAILRUNNER-ALZ 1)

JRCT ID: jRCT2031220471

Registered date:28/11/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Alzheimer's Disease
• Date of first enrollment: 17/02/2023
• Target sample size: 600
• Countries of recruitment: United States,Japan
• Study type: Interventional

Intervention(s)

-Drug: Remternetug (IV)
Administered IV
Other Name: LY3372993
-Drug: Remternetug (SC)
Administered SC
Other Name: LY3372993
-Drug: Placebo
Administered IV or SC
-Experimental: Remternetug (IV)
Participants will receive remternetug intravenously (IV)
Participants will receive remternetug IV during the treatment period, then switch to placebo IV in the extension period.
-Experimental: Remternetug (SC)
Participants will receive one of two dosinf regimens of remternetug subcutaneously (SC)
Participants will receive remternetug SC during the treatment period, then switch to placebo SC in the extension period.
-Placebo Comparator: Placebo
Participants will receive placebo matching remternetug IV or SC.
Participants will receive placebo IV during the treatment period, then switch to remternetug IV the extension period.
Participants will receive placebo SC during the treatment period, then switch to LY3372993 SC in the extension period.
-Experimental: Open-Label Addenda Remternetug (IV)
Participants will receive one of three dosing regimens of remternetug IV during the open-label addenda.
-Experimental: Open-Label Addenda Remternetug (SC)
Participants will receive one of two dosing regimens of remternetug SC during the open-label addenda.

Outcome(s)

• Primary Outcome: Percentage of Participants Who Reach Amyloid Plaque Clearance on Amyloid PET Scan for Remternetug versus Placebo [ Time Frame: Week 52 ]

Key inclusion & exclusion criteria

• Age minimum: >= 60age old
• Age maximum: <= 85age old
• Gender: Both

Include 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.

Exclude 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 amyloid-beta peptide in any other study.
-Have known allergies to remternetug related compounds, or any components of the formulation.

Related Information

• Primary Sponsor: Masaki Takeshi
• Secondary ID(s): NCT05463731