臨床研究等提出・公開システム

A Study of Remternetug Versus Placebo in Early Alzheimer's Disease Participants at Risk for Cognitive and Functional Decline (J1G-MC-LAKI)

A Study of Remternetug (LY3372993) in Early Alzheimer's Disease (TRAILRUNNER-ALZ 3) (J1G-MC-LAKI)

Masaki Takeshi

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

LTG_CallCenter@lists.lilly.com

Trial Guide Call Center

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

+81-120-023-812

LTG_CallCenter@lists.lilly.com

Not Recruiting

Nov. 21, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- Have a phosphorylated tau (P-tau) result consistent with the presence of amyloid pathology.
- Have a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.
- Have adequate literacy, vision, and hearing for neuropsychological testing at screening.
- Have a Mini Mental Status Exam (MMSE) score consistent with no to minimal cognitive impairment.
- Have a Functional Activities Questionnaire (FAQ) score consistent with no to minimal functional impairment.
- If currently receiving medications as symptomatic treatment for AD, dose has been stable for at least 30 days before screening.

- Have dementia or significant other neurological disease that can affect cognition.
- Have current serious or unstable illnesses that in the investigator's opinion, could interfere with the analyses of the study.
- Have a history of cancer that, in the investigator's opinion, has a high risk of recurrence.
- Have a history of clinically significant multiple or severe drug allergies, or hypersensitivity reactions.
- Have a clinically important laboratory test result or other abnormality as determined by investigator, prior to radomization, that could be detrimental to the participant or could compromise the study.
- Have any contraindications for magnetic resonance imaging (MRI).
- Have a centrally read MRI that does not meets study entry criteria.
Prior or Current Therapies
- Have ever had prior treatment with a passive anti-amyloid immunotherapy.
- Have received active immunization against AB in any other study.

Both

Alzheimer's Disease

DRUG: Remternetug(Other Name: LY3372993)
Administered SC
DRUG: Placebo
Administered SC

[Study Arms]
Experimental: Remternetug
Remternetug administered subcutaneously (SC).
Interventions:
Drug: Remternetug
Placebo Comparator: Placebo
Placebo administered SC.
Interventions:
Drug: Placebo

Time to Clinically Meaningful Progression as Measured by Clinical Dementia Rate (CDR) [ Time Frame: Baseline to Time to Event up to Week 255
Time to clinically meaningful progression as measured by CDR. CDR is a clinician-rated scale that provides an overall assessment of the participant's stage and degree of impairment across the continuum of early Alzheimer's Disease (AD).

+81-42-625-5216

Nov. 11, 2024

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.

United States