A Study on the Safety, Tolerability and Immunogenicity of ALZ-101 in Participants With Early Alzheimer's Disease
- Conditions
- Alzheimer DiseaseDementia AlzheimersDementia, Mild
- Interventions
- Other: Placebo
- Registration Number
- NCT05328115
- Lead Sponsor
- Alzinova AB
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ALZ-101 125 μg ALZ-101 Intramuscular injection of 125 μg of ALZ-101 adjuvanted vaccine dosed once a month at four doses ALZ-101 400 μg ALZ-101 Intramuscular injection of 400 μg of ALZ-101 adjuvanted vaccine dosed once a month at four doses Placebo Placebo Intamuscular Saline solution mixed adjuvant and dosed once a month at four doses ALZ-101 250 μg ALZ-101 Intramuscular injection of 250 μg of ALZ-101 adjuvanted vaccine dosed once a month at four doses
- Primary Outcome Measures
Name Time Method Number of participants with treatment-emergent AEs and SAEs From enrolment through study completion, an average 1 year Any adverse or serious adverse events that could be associated with the treatment.
Number of participants with clinically significant cognitive or functional worsening of Alzheimer's Disease(AD) according to Alzheimer's DiseaseCooperative Study -Clinician's Global Impression of Change (ADCS-CGIC)scores of 6 and 7 From first dose to study completion, an average 1 year Any clinically significant worsening of cognitive functions as assessed by Alzheimer's DiseaseCooperative Study -Clinician's Global Impression of Change \[ADCS-CGIC\]scores. Scores are graded from 1 to 7, where 1 means very much improved cognitive function and 7 very much worsening cognitive function.
Number of AEs of special interest (AESIs), including injection-related events (IREs)and amyloid-related imaging abnormalities (ARIAs) From enrolment through study completion, an average 1 year Any adverse or adverse events of special interest that could be associated with the treatment.
Number of adverse events (AEs) and serious AEs (SAEs) From enrolment through study completion, an average 1 year Any adverse or serious adverse events that could be associated with the study procedure.
- Secondary Outcome Measures
Name Time Method Number of titre-based responders From first dose to study completion, an average 1 year Number of titre-based responders, defined as post-baseline sample becoming positive for Aβ-specific antibodies(if baseline sample is negative) OR post-baseline titre at least four times the baseline antibody titre in serum
Aβ-specific antibody titre From first dose to study completion, an average 1 year Aβ-specific antibody titre of post-baseline samples (if baseline sample is negative) OR titre fold increase defined as the ratio of any post-baseline Aβ-specific antibody titre to baseline antibody titre in serum
Area under serum Aβ-specific antibody titre curve (AUC) From first dose to week 20 Area under serum Aβ-specific antibody titre curve (AUC) from Week 0 to Week 20.
Trial Locations
- Locations (1)
Clinical Research Services Turku -CRST Oy
🇫🇮Turku, Finland