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Clinical Trials List

Protocol NumberI5T-MC-AACO
Active

2024-04-01 - 2028-12-31

Phase III

Recruiting11

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

Global Study to Investigate Safety and Efficacy of Donanemab in Early Symptomatic Alzheimer’s Disease

  • Trial Applicant

    ELI LILLY AND COMPANY(TAIWAN), INC.

  • Sponsor

    Eli Lilly and Company

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 楊富吉 Division of Neurology
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yu-Wan Yang Division of Neurology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳怡君 Division of Neurology
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 張瓊之 Division of Neurology
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 劉議謙 Division of Neurology
Cardinal Tien Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Chyi Pai Division of Neurology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TA-FU CHEN Division of Neurology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 方楨文 Division of Neurology
National Taiwan University Hospital Yunlin Branch

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jong-Ling Fuh Division of Neurology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 方楨文 Division of Neurology
國立臺灣大學醫學院附設醫院雲林分院

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chaur-Jong Hu
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Alzheimer’s Disease

Objectives

To assess the effect of donanemab versus placebo on clinical progression in participants with early symptomatic AD

Test Drug

injection

Active Ingredient

LY3002813
LY3191748
F18-Florbetaben

Dosage Form

246
27H
27H
27H

Dosage

17.5 mg /mL；20 mL
300 MBq/mL to 3,700 MBq/mL (8.1 mCi/mL-100 mCi/mL)
300 百萬貝克 (8.1毫居里 )，溶液體積至多為 10毫升

Endpoints

iADRS change from baseline through
Week 76 in at least 1 of
 the low-medium tau pathology
population or
 the overall population

Inclution Criteria

• Participants or informed witnesses report progressive changes in memory function for ≥ 6 months.

• MMSE score of 20 to 28 (inclusive) on day 601 or day 1.

• Meets the criteria for a Flortaucipir F18 scan (interpreted centrally).

• Meets the criteria for a Flortaucipir F18 scan (interpreted centrally).

• Has a research partner who can provide written informed consent, maintain frequent contact with the participant (defined as at least 10 hours per week), accompany the participant to the trial, or be available to contact the participant by telephone at designated times.

• A second research partner can be a backup candidate. A research partner must accompany the participant when signing the consent form. The research partner must be present on all days the cognitive and functional scales are administered.

• If the participant has a second research partner, it is best if one research partner serves as the primary assessor for the CDR and Alzheimer's Disease Collaborative Research Association - Activities of Daily Living Scale (ADCS-ADL).

• Participants are required to complete the following assessment items and scales on the dates on which their research partner is unable to accompany them for these assessments and must be able to contact them by phone.

AE and concurrent medication

CDR, and

ADCS-ADL

• Participants must have been in stable condition with symptomatic AD medication and other medications that may affect cognition for at least approximately 30 days prior to randomization.

Exclusion Criteria

• Obvious neurological disorders other than Alzheimer's disease that have affected the central nervous system to the point of impairing cognition or the ability to complete this trial, including other forms of dementia, severe brain infections, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures (excluding febrile seizures in children), but not limited to these.

• Currently suffering from a serious or unstable illness, including cardiovascular, liver, kidney, gastrointestinal, respiratory, endocrine, neurological (non-Alzheimer's), psychiatric, immune, or hematologic disorders, and other conditions that, in the opinion of the trial administrator, may interfere with the analysis of this trial; or a life expectancy of less than 24 months.

• A history of cancer within the past 5 years, excluding non-metastatic basal cell and/or squamous cell carcinoma of the skin, cervical carcinoma in situ, non-advanced prostate cancer, or other cancers with a low risk of recurrence or spread.

• Contraindications to MRI or PET scans.

The Estimated Number of Participants

  • Taiwan

    60 participants

  • Global

    1500 participants

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