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A Phase 2, Placebo-Controlled, Double-Blind, Parallel-Group, Dose-Finding Study to Evaluate Safety, Tolerability, and Biomarker Efficacy of E2814 With Concurrent Lecanemab Treatment in Subjects With Early Alzheimer's Disease

A Study of E2814 With Concurrent Lecanemab Treatment in Participants With Early Alzheimer's Disease

Nakagawa Masaki

Eisai Co., Ltd.

4-6-10 Koishikawa, Bunkyo-ku, Tokyo

eisai-chiken_hotline@hhc.eisai.co.jp

Inquiry service

Eisai Co., Ltd.

4-6-10 Koishikawa, Bunkyo-ku, Tokyo, Japan

+81-80-1292-6296

eisai-chiken_hotline@hhc.eisai.co.jp

Not Recruiting

Dec. 31, 2024

Interventional

randomized controlled trial

double blind

dose comparison control

parallel assignment

treatment purpose

1. Mild cognitive impairment (MCI) due to AD or mild AD dementia
2. Mini Mental State Examination (MMSE) score >=22 at Screening and Baseline and less than or equal to (<=) 30 at Screening and Baseline
3. Able to have CSF lumbar puncture performed and not on any anticoagulant therapy
4. Have an identified study partner
5. Provide written informed consent and willing and able to comply with all aspects of the protocol

1. Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the participant's AD
2. Any psychiatric diagnosis or symptoms that could interfere with study procedures in the participants
3. Contraindications to MRI scanning. Evidence of other clinically significant lesions on brain MRI at Screening that could indicate a dementia diagnosis other than AD, or other significant pathological findings
4. A clinically significant ECG abnormality
5. Participants with a bleeding disorder that is not under adequate control
6. Have thyroid-stimulating hormone above normal range or abnormally low serum vitamin B12 levels
7. Any suicidal ideation with intent with or without a plan at Screening, Baseline, or within 6 months of Screening (that is, answering ""Yes"" to questions 4 or 5 on the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale [C-SSRS]) Type 4 or 5, or any suicidal behavior assessment within 6 months before Screening, at Screening, or at the Baseline Visit, or has been hospitalized or treated for suicidal behavior in the past 5 years before Screening)
8. Evidence of clinically significant disease that in the opinion of the investigator(s) could affect the participants safety or interfere with the study assessments
9. Any immunological disease, that is not adequately controlled
10. Any history of or concomitant medical condition that in the opinion of the investigator(s) would compromise the participant's ability to safely complete the study
11. Known to be human immunodeficiency virus positive
12. Severe visual or hearing impairment that would prevent the participant from performing psychometric tests accurately

Both

early AD

Generic Name: NA
Study Treatment: Participants will receive E2814 (Dose A/Dose B/Dose C/Dose D) or Placebo as IV infusion, Q4W along with lecanemab administered as SC injection, QW.

Change From Baseline in Cerebrospinal Fluid Microtubule-binding Region-tau-243 (CSF MTBR-tau-243) up to 6 Months

+81-827-57-7151

Oct. 10, 2024

Yes

https://www.eisai.com/company/business/research/clinical/index.html

United States