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
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.
• Male and female subjects between 50 and 83 years (inclusive) of age at the time of informed consent
• Subjects capable of providing valid independent informed consent and signing the informed consent form (the subjects' capacity to provide valid consent should be determined in accordance with applicable professional standards, and will be based on the Investigator's judgement)
• Subjects with MCI due to AD or mild AD according to National Institute of Aging - Alzheimer's Association (NIA-AA) core clinical criteria; subjects must have all of the following at screening:
‣ CDR global score (GS) of 0.5 or 1
⁃ CDR memory score of ≥0.5
⁃ MMSE score of ≥20 points
• Screening CSF results showing a pattern consistent with amyloid plaque load and indicative of AD pathology. The CSF results will be evaluated by the Investigator and will take into account the Aβ42/40 ratio (cut-off level set by the laboratory)
• If the subject is receiving an acetylcholine esterase inhibitor (AChEI) or memantine or both for the treatment of MCI or AD, this treatment must be on a stable dosage for at least 8 weeks prior to the first dosing of IMP. Treatment-naïve subjects may also be entered into the study
• Subjects must have an identified, reliable and knowledgeable study partner who is willing and able to support the participant and to provide follow-up information on the study participant throughout the course of the study. This person must, in the opinion of the Investigator, spend sufficient time with the study participant on a regular basis such that he or she can reliably fulfil the requirements of being a study partner (however, a study partner does not need to be living in the same household with the study participant)
• Male and female subjects who have completed Visit 15 of Part A and are willing to continue in Part B of the study
• Subjects providing informed consent and signing the informed consent form. In case a subject is considered not to be capable of providing valid independent informed consent, the subject's legally acceptable representative (LAR) should consent to the study on behalf of the subject. In such a case, the subject should provide informed assent to continue in the study
• Subjects must have an identified, reliable and knowledgeable study partner who is willing and able to support the participant and to provide follow-up information on the study participant throughout the course of the study. This person must, in the opinion of the Investigator, spend sufficient time with the study participant on a regular basis such that he or she can reliably fulfil the requirements of being a study partner.