EUCTR2016-004352-30-IT进行中（未招募）1 期
A Multi-center, Randomized, Doubleblind, Placebo-controlled, 24 months Study in Patients with amnestic Mild Cognitive Impairment or Very Mild Alzheimer’s Disease to Investigate the Safety, Tolerability and Immune Response of Repeated Subcutaneous Injections of ABvac40. - na
ARACLON BIOTECH S.L.0 个研究点目标入组 120 人开始时间: 2021年1月21日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male or female between 55 and 80 years of age, both inclusive, at the
- •time of signing informed consent.
- •2. The patient (or legal representative, if applicable) and a close
- •relative/caregiver must read the subject information sheet, agree to
- •participate in the clinical trial and sign the informed consent form (the
- •patient and a close relative/caregiver).
- •3. Presence of a stable caregiver to attend the patient study visits.
- •4. Mini-Mental Status Examination (MMSE) score between 24 and 30
- •points (inclusive), according to age and education level.
- •5. Clinical Dementia Rating (CDR) scale scoring 0.5.
- •6. Repeatable Battery for the Assessment of Neuropsychological Status
- •(RBANS) Score on the Delayed Memory Index (DMI) of 85 or lower.
- •7. The results of the patient's MRI brain scan must be concordant with
- •the diagnosis of clinical a-MCI or vm-AD according to the followingcriteria: Scheltens scale, and measurement of white matter and past
- •haemorrhages.
- •8. If the patient is receiving treatment for AD, must have been stable
- •during the two months before the selection visit.
- •9. Treatment for concomitant diseases must be stable during the
- •previous month before the treatment of the study.
- •10. Positive assessment of the candidate by the investigator for
- •complying with the requirements and procedures of the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 90
排除标准
- •1. Known allergy to components of the vaccine or prior history of anaphylaxis, a severe allergic reaction or a history of hypersensitivity to any component of the formulation. Allergy to fish or shellfish.
- •2. Active infectious disease (i.e. hepatitis B, C). Positive syphilis serology.
- •3. History or presence of autoimmune disease, except mild eczema, rhinitis or psoriasis.
- •4. Presence or history of immunodeficiency (i.e. HIV).
- •5. Significant kidney and/or liver disease, as defined by plasma creatinine =2.5 mg/dL (221 µmol/l) and/or total bilirubin >3 mg/dL (51.3 µmol/l) measured at the local site laboratory.
- •6. History of asthma or reactive airway disease with bronchospasm in the last 6 months, or currently on regular treatment.
- •7. Major uncontrolled systemic condition (e.g. diabetes, congestive heart failure, hypertension).
- •8. History of cancer (=5 years since the last specific treatment). Exceptions: basocellular carcinoma.
- •9. Significant alterations in hematological, biochemical or urine analytical parameters, particularly those relating to levels of vitamin B12, folic acid or thyroid tests.
- •10. History of any other central nervous system disorder, degenerative or non-degenerative neurological or psychiatric condition that, in the investigator's opinion could be the cause of the dementia, or could explain the cognitive impairment, or that might interfere with cognitive function directly or by its treatment.
- •11. Geriatric Depression Scale (GDS; abbreviated version), score >5
- •12. Has a yes answer to C-SSRS suicidal ideation items 4 or 5, or any suicidal behavior within 6 months before Screening, or has been hospitalized or treated for suicidal behavior in the past 5 years before Screening.
- •13. History or signs of cerebrovascular disease (ischemic or haemorrhagic stroke, transient ischemic attack), or diagnosis of possible, probable or clear vascular dementia according to NINDS-AIREN criteria.
- •14. Presence on MRI of a relevant pattern of microvascular disease (Leukoaraiosis, Fazekas score =2 in the deep white matter scale or =4 in the global score) or more than one lacunar or territorial infarcts. Any other MRI finding that, in the opinion of the investigator, might be a relevant contributing cause of subject´s cognitive impairment. Presence of up to 3 microhemorrhages will be acceptable.
- •15. History of bleeding disorder or predisposing conditions, blood clotting or clinically significant abnormal results on coagulation profile at Screening, as determined by the Investigator.
- •16. Patients being treated with anticoagulants or antiaggregant therapy (aspirin at a prophylactic dose =325 mg daily or clopidogrel at a dose = 75 mg daily are allowed) should not be recruited in the study.17. Modified Hachinski Ischemic Scale, score higher than 4.
- •18. Surgery (with general anaesthetic) within the previous three months to be included in the trial, or programed during the study period.
- •19. Treatment within 30 days prior to visit 0 with systemic corticosteroids or other immunosuppressant's.
- •20. Vaccination against influenza or any other vaccination within 2 months before first IMP dose.
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