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

Sponsor
Alzinova AB
Study ID
NCT05328115
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 83 Years
Healthy Volunteers
Not accepted

Interventions

  • ALZ-101 — BIOLOGICAL
    Intramuscular injections of adjuvanted peptide vaccine against oligomeric Amyloid Beta.
  • Placebo — OTHER
    Intramuscular injections of adjuvanted placebo.

Study Details

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.

Key Dates

Start date
Sep 30, 2021
Status verified
Jan 2025
Primary completion
Jan 27, 2025
Completion
Jan 27, 2025

Study Design

Enrollment
33 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: ALZ-101 125 μg
    Intramuscular injection of 125 μg of ALZ-101 adjuvanted vaccine dosed once a month at four doses
  • Active Comparator: ALZ-101 250 μg
    Intramuscular injection of 250 μg of ALZ-101 adjuvanted vaccine dosed once a month at four doses
  • Placebo Comparator: Placebo
    Intamuscular Saline solution mixed adjuvant and dosed once a month at four doses
  • Active Comparator: ALZ-101 400 μg
    Intramuscular injection of 400 μg of ALZ-101 adjuvanted vaccine dosed once a month at four doses

Primary Outcome Measure

Number of adverse events (AEs) and serious AEs (SAEs) [ Time Frame: From enrolment through study completion, an average 1 year ]

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