Status and phase
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About
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.
Enrollment
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Volunteers
Inclusion and exclusion criteria
Main inclusion criteria in Part A:
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:
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)
Main inclusion criteria in Part B:
Main exclusion criteria in Part A:
Subjects having any contraindication to MRI scanning; or are unable to undergo brain MRI scanning according to the standard criteria of the MRI unit; or the Investigator believes that the subject will not be able to undergo further scans scheduled during the course of the study
Screening MRI (3T) results showing evidence of clinically significant pathological lesions that could indicate a dementia-associated diagnosis other than early AD or cause a safety risk for the participant (a list of possible exclusionary findings is included in the main protocol text)
Modified Hachinski Ischemia Score (mHIS) >4 at screening
History of a cerebrovascular incident, including transient ischemic attack (TIA) or stroke, within 12 months of screening
Subject with a history of seizures within 2 years of screening
Any psychiatric diagnosis or symptoms (e.g. hallucinations, major depression, delusions, schizophrenia, bipolar disorder) that, in the opinion of the Investigator, could interfere with study procedures or assessments or participant safety. A subject with depression may, however, be included if treated with a stable dose of antidepressants for at least 8 weeks before screening and not fulfilling DSM-5 criteria for major depression at screening
Significant risk of suicide (defined using the Columbia Suicide Severity Scale [C-SSRS], with the subject answering "yes" to suicidal ideation questions 4 or 5 or answering "yes" to suicidal behaviour) within 12 months of screening
Disorder related to alcohol or drug abuse, as defined in DSM-5, within 2 years prior to screening
Evidence of current or history of any significant autoimmune disease that, in the opinion of the Investigator, could interfere with evaluation of the study results or constitute a health hazard for the subject
Evidence of an immune system that is compromised; including, but not limited to, a diagnosis of HIV (human immunodeficiency virus); or the subject has been splenectomised or has received an organ transplant (corneal transplants excluded), or is receiving chronic systemic immunosuppressive medication
Evidence of current clinically significant and possibly unstable pulmonary, gastrointestinal, renal, hepatic, endocrine, hematological or cardiovascular system disease or metabolic disturbance
Diagnosis of cancer (hematological or solid tumor) for which the subject is currently being treated, or for which there has been treatment within 5 years preceding screening, or for which there is still evidence of active disease. Subjects with local prostate cancer or local dermatological tumors, such as basal or squamous cell carcinoma, may be included
Any clinically significant abnormalities in laboratory tests, vital signs, ECG or physical examination findings at screening that in the opinion of the Investigator require further investigation or treatment, or may interfere with study procedures or safety. These may include, but are not limited to, the following:
Clinically suspected active neuroborreliosis, confirmed by the presence of Borrelia antibodies in CSF
Contraindication to lumbar puncture (LP). These contraindications may include, but are not limited to, the following:
Current or anticipated use, or recent prior use (pre-study time limits specified in the main protocol text) of disallowed concomitant treatment
Any vaccination within 2 weeks prior to screening
History of severe drug allergy (anaphylactic shock or drug-induced hypersensitivity syndrome), or known hypersensitivity to vaccines, including constituents of vaccines Having received in another clinical trial
Any condition that may be contributing to cognitive impairment above and beyond that caused by the subject's early AD 21. Disease or medication that, in the opinion of the Investigator, could interfere with the assessments of safety, tolerability or immunogenicity 22. Planned surgery that would take place during the double-blind treatment period of the study. Planned surgery not requiring general anaesthesia need not result in exclusion, if in the opinion of the Investigator this operation does not interfere with study procedures and participant safety 23. Blood donation or loss of significant amount of blood within 3 months prior to the first screening visit 24. Female subjects of childbearing potential
Main exclusion criteria in Part B:
Primary purpose
Allocation
Interventional model
Masking
33 participants in 4 patient groups, including a placebo group
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Central trial contact
Karin Arnesson, CPM; Kirsten Harting, MD
Data sourced from clinicaltrials.gov
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