NCT05328115

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

A Double-blind, Randomized, Parallel-group Multiple Dose Study on the Safety, Tolerability and Immunogenicity of ALZ-101 in Participants With Early Alzheimer's Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Alzinova AB · Industry
• Sex: All
• Age: 50 Years – 83 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alzheimer Disease
• Dementia Alzheimers
• Dementia, Mild

Interventions

Type	Name	Description
BIOLOGICAL	ALZ-101	Intramuscular injections of adjuvanted peptide vaccine against oligomeric Amyloid Beta.
OTHER	Placebo	Intramuscular injections of adjuvanted placebo.

Timeline

• Start date: 2021-09-30
• Primary completion: 2025-01-27
• Completion: 2025-01-27
• First posted: 2022-04-14
• Last updated: 2025-01-31

Locations

1 site across 1 country: Finland