Clinical Trials List
2024-02-01 - 2029-12-31
Phase III
Recruiting7
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
Assessment of safety and efficacy of subcutaneous remternetug in early symptomatic Alzheimer’s disease
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Trial Applicant
ELI LILLY AND COMPANY(TAIWAN), INC.
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Sponsor
Eli Lilly and Company
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Jung-Lung Hsu 無
- Chi-Hung Liu 無
- Kun-Ju Lin 無
- Chin-Chang Huang 無
- Kung-Chu Ho 無
- 張庭瑜 無
- Hsiu-Chuan Wu 無
- Hong-Chou Kuo 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chia-Fen Tsai 無
- 林詠萱 無
- Chun-Yu Chen 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
the intermediate tau pathology population, or
the intermediate to high tau population
Inclution Criteria
2. Gradual and progressive change in cognitive function reported by the participant or informant for ≥6 months from screening.
3. An MMSE score of 20 to 28 (inclusive) at Visit 601 or Visit 1, as determined at the time of screening.
4. Have a biomarker consistent with the presence of brain amyloid pathology, via:
Historical biomarker, if available, or,
Prospective plasma biomarker, if available per sponsor discretion.
Note: If neither are available, refer to Section 4.1.
5. Have a tau PET scan (central read) result consistent with the presence of tau pathology. A historical tau PET scan may be submitted to be considered for eligibility if performed within 6 months of randomization. The acceptance of a historical scan is at the discretion of the sponsor.
6. If on concomitant symptomatic AD medications or other medications that may impact cognition, then must be on a stable dose for at least approximately 28 days prior to randomization (does not apply to topical, as needed [prn], or discontinued medications).
7. Have a reliable study partner who will provide written informed consent to participate and is in frequent contact with the participant.
The study partner must be capable of giving signed informed consent and complying with the requirements listed in the informed consent form and in this protocol. The study partner or a caregiver must provide oversight for weekly at home subcutaneous injections and be willing and able to administer the injection, as necessary.
Exclusion Criteria
13. 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
The Estimated Number of Participants
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Taiwan
40 participants
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Global
1300 participants
