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Clinical Trials List

Protocol NumberI5T-MC-AACO
NCT Number(ClinicalTrials.gov Identfier)NCT05508789
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

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/06/18

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

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator
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 Ming-Chyi Pai
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Alzheimer Disease

Objectives

To evaluate the safety and efficacy of donanemab in participants with early symptomatic Alzheimer's disease.

Test Drug

Intravenous infusion solutions
Injection solutions (aseptic preparation)
Injection solutions (aseptic preparation)
Injection solutions (aseptic preparation)

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 million becquerels (8.1 millicuries), with a maximum solution volume of 10 mL.

Endpoints

The change in iADRS from baseline to week 76 was within at least one of the following groups: low- to moderate tau protein lesions, or the overall population.

Inclution Criteria

Inclusion Criteria:

Gradual and progressive change in memory function reported by the participant or informant for ≥6 months.
A MMSE score of 20 to 28 (inclusive) at screening visit.
Meet amyloid scan (central read) criteria.
Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (defined as at least 10 hours per week), and will accompany the participant to the study or be available by telephone at designated times.
A second study partner may serve as backup. The study partner(s) is/are required to accompany the participant for signing consent. The study partner must be present on all days the cognitive and functional scales are administered.
If a participant has a second study partner, it is preferred that 1 study partner be primarily responsible for the CDR and the ADCS-ADL assessments.
Days requiring the following assessments and scales must have a study partner available by telephone if not accompanying participant for the following assessments

AEs and concomitant medications
CDR, and
ADCS-ADL
Stable concomitant symptomatic AD medications and other medications that may impact cognition for at least approximately 30 days prior to randomization.

Exclusion Criteria

Exclusion Criteria:

Has significant neurological disease affecting the central nervous system other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, or epilepsy or recurrent seizures (except febrile childhood seizures).
Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions 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 within the last 5 years, except of non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, nonprogressive prostate cancer, or other cancers with low risk of recurrence or spread.
Contraindication to MRI or PET scans.

The Estimated Number of Participants

  • Taiwan

    80 participants

  • Global

    1500 participants

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