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Clinical Trials List

Protocol NumberJ1G-MC-LAKI
NCT Number(ClinicalTrials.gov Identfier)NCT06653153
Active

2025-01-01 - 2031-12-31

Phase III

Recruiting12

ICD-10G30.0

Alzheimer's disease with early onset

ICD-10G30.1

Alzheimer's disease with late onset

ICD-10G30.8

Other Alzheimer's disease

ICD-10G30.9

Alzheimer's disease, unspecified

ICD-9331.0

Alzheimer's disease

A Study of Remternetug Versus Placebo in Early Alzheimer's Disease Participants at Risk for Cognitive and Functional Decline

  • Trial Applicant

    ELI LILLY AND COMPANY(TAIWAN), INC.

  • Sponsor

    台灣禮來股份有限公司

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/04/10

Investigators and Locations

Principal Investigator Yu-Wan Yang Division of Neurology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TA-FU CHEN Division of Neurology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 方楨文 Division of Neurology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jong-Ling Fuh

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 張瓊之

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 劉議謙

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 王文甫

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Chyi Pai

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Alzheimer's Disease

Objectives

The aim of this study is to gain a deeper understanding of remternetug, a new drug that may be used to treat early-stage Alzheimer's disease (AD). This trial aims to understand: • Whether remternetug can delay the onset or worsening of memory and thinking problems caused by AD. • Whether remternetug is more effective than a placebo (a drug that is inactive or "disguised"). • The potential side effects of remternetug.

Test Drug

Prefilled Injectable

Active Ingredient

Remternetug

Dosage Form

230

Dosage

400MG

Endpoints

Outcome Measurement: Measured up to the time of clinically significant deterioration using the Clinical Dementia Assessment Scale (CDR).

Measurement Description: Measured up to the time of clinically significant deterioration using the CDR. The CDR is a clinician-rated scale that provides an overall assessment of the stage and extent of impairment in the early stages of Alzheimer's disease (AD) in participants.

Time Range: From the baseline period to the time of the event, up to week 255.

Inclution Criteria

Inclusion Criteria:

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.

Exclusion Criteria

Exclusion Criteria:

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 randomization, 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.

The Estimated Number of Participants

  • Taiwan

    67 participants

  • Global

    1400 participants