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

NCT05328115 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2025-01-31

No results posted yet for this study

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

BIOLOGICAL

ALZ-101

Intramuscular injections of adjuvanted peptide vaccine against oligomeric Amyloid Beta.

OTHER

Placebo

Intramuscular injections of adjuvanted placebo.

Sponsors & Collaborators

  • CRST Oy

    collaborator INDUSTRY

  • Alzinova AB

    lead INDUSTRY

Principal Investigators

  • Juha Rinne, MD · CRST Oy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
83 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2025-01-27
Completion
2025-01-27

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05328115 on ClinicalTrials.gov