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
Overview
- Phase
- Phase 1
- Intervention
- ALZ-101
- Conditions
- Alzheimer Disease
- Sponsor
- Alzinova AB
- Enrollment
- 33
- Locations
- 1
- Primary Endpoint
- 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
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
ALZ-101 125 μg
Intramuscular injection of 125 μg of ALZ-101 adjuvanted vaccine dosed once a month at four doses
Intervention: ALZ-101
ALZ-101 250 μg
Intramuscular injection of 250 μg of ALZ-101 adjuvanted vaccine dosed once a month at four doses
Intervention: ALZ-101
Placebo
Intamuscular Saline solution mixed adjuvant and dosed once a month at four doses
Intervention: Placebo
ALZ-101 400 μg
Intramuscular injection of 400 μg of ALZ-101 adjuvanted vaccine dosed once a month at four doses
Intervention: ALZ-101
Outcomes
Primary Outcomes
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
Time Frame: 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)
Time Frame: 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)
Time Frame: From enrolment through study completion, an average 1 year
Any adverse or serious adverse events that could be associated with the study procedure.
Number of participants with treatment-emergent AEs and SAEs
Time Frame: From enrolment through study completion, an average 1 year
Any adverse or serious adverse events that could be associated with the treatment.
Secondary Outcomes
- Number of titre-based responders(From first dose to study completion, an average 1 year)
- Aβ-specific antibody titre(From first dose to study completion, an average 1 year)
- Area under serum Aβ-specific antibody titre curve (AUC)(From first dose to week 20)