A Study on the Safety, Tolerability and Immunogenicity of ALZ-101 in Participants With Early Alzheimer's Disease

Summary

The main purpose of this study is to evaluate safety, tolerability and immunogenicity of the vaccine ALZ-101 against Alzheimer's Disease. Patients diagnosed with early Alzheimer's will be included. The study have two parts. The Part A (including A1 and A2), includes four doses of ALZ-101 or corresponding placebo given over 16 weeks. Participant will be followed up to Week 30 in Part A1 and either continue in the extension part of the study, Part B, or complete Part A1. Participant not eligible to Part B will be followed up until Week 68 with no further dosing. Participant eligible for Part B will be treated with 2 doses of open-label ALZ-101, over 16 weeks and followed up during in total 68 weeks (Part A1 and B). Part A2 participants will be followed over 20 weeks.

Timeline

Start

2021-09-30

Primary completion

2025-01-27

Completion

2025-01-27

Publications

• Lovro Z, Sandberg A, Zetterberg H, Pierrou S, Parkkola R, Sjogren N, Scheinin M, Rinne JO. Safety, tolerability and immunogenicity of vaccine ALZ-101 in patients with early Alzheimer's disease: randomised, controlled trial. Alzheimers Res Ther. 2026 May 19. doi: 10.1186/s13195-026-02082-9. Online ahead of print.

Drugs

Indications