EUCTR2015-000630-30-SK进行中（未招募）1 期
ADAMANT” A 24-months randomised, placebo-controlled, parallel group, double blinded, multi centre, phase 2 study to assess safety and efficacy of AADvac1 applied to patients with mild Alzheimer’s disease - ADAMANT
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 208
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
入选标准
- •1. Patient has a diagnosis of probable Alzheimer’s disease according to the revised NIA-AA criteria (McKhann 2011).
- •2. Patient has a MMSE total score = 20 and = 26 at Screening.
- •3. Patient has a brain MRI finding consistent with the diagnosis of Alzheimer’s disease at Screening.
- •4. Patient has evidence of the AD pathophysiological process at Screening, defined as one or both of the following:
- •a. medial temporal lobe atrophy as assessed on brain MRI and according to a Scheltens score of = 2 (rated on a scale of 0-4 on the more atrophied side)
- •b. positive AD biomarker signature in the CSF (total tau protein > 400 pg/mL AND pT181 tau protein > 60 pg/mL AND Aß42 < 600 pg/mL AND Aß42:Aß40 ratio < 0,089)
- •5. Patient had completed 6 years of formal elementary education.
- •6. Patients aged 50-85 years inclusive at Screening.
- •7. Patient is fluent in the local language and possesses sufficient auditory and visual capacities to allow neuropsychological testing.
- •8. Patient is able to read and understand the informed consent.
- •9. Patient is on a stable therapy with an acetylcholinesterase inhibitor for at least 3 months prior to screening visit.
- •10. If the patient is on memantine treatment, the dose regimen must be stable for at least 3 months prior to Screening (V01).
- •11. Patient has a Hachinski Ischemia Scale score = 4 at Screening.
- •12. Availability of a caregiver who sufficiently knows the patient and will be able to accompany the patient on the study visits and to participate in study assessments of the patient where required.
- •13. Female patients are only eligible for the study if they are either surgically sterile or at least 2 years postmenopausal.
- •14. Male patients must either be surgically sterile, or he and his female spouse/partner who is of childbearing potential must be using highly effective contraception consisting of 2 forms of birth control (1 of which must be a barrier method) starting at screening and continuing throughout the study period.
- •15. Patient provides written informed consent.
- •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 41
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 167
排除标准
- •1. Female patient who is pregnant or breastfeeding.
- •2. Patient has been participating in another clinical study within 3 months prior to Screening.
- •3. Patient is not expected to complete the clinical study.
- •4. Patient has known allergy to components of the vaccine currently or in the past, if considered relevant by the investigator.
- •5. Patient has known contraindication for MRI imaging such as MRI-incompatible metallic endoprosthesis or MRI-incompatible stent implantation or other as judged by the Investigator.
- •6. Any of the following detected by brain MRI:
- •a) Infarction in the territory of large vessels
- •b) More than one lacunar infarct defined as a focal lesion of CSF signal intensity with a diameter of less than 1.5 cm in any dimension.
- •c) Any lacunar infarct in a strategically important location such as the thalamus, hippocampus of either hemisphere, head of the left caudate nucleus.
- •d) Confluent hemispheric deep white matter lesions (Fazekas grade 3).
- •e) Other focal lesions which may be responsible for the cognitive status of the patient such as infectious disease, space-occupying lesions, normal pressure hydrocephalus or any other abnormalities associated with significant central nervous disease other than Alzheimer’s disease.
- •7. Patient underwent surgery (under general anaesthesia) within 3 months prior to screening and/or has scheduled surgery (under general anaesthesia) during the whole study period.
- •8. Patient has a history and/or currently suffers from a clinically significant autoimmune disease, or is expected to receive immunosuppressive or immunomodulatory treatment at the present or in the future.
- •9. Patient has a recent history of cancer (last specific treatment = 5 years prior to Screening) (Exceptions: basal cell carcinoma, intraepithelial cervical neoplasia).
- •10. Patient had myocardial infarction within the last 2 years prior to Screening.
- •11. Patient has Hepatitis B, C, HIV or Syphilis confirmed by serology.
- •12. Patient suffers from an active infectious disease.
- •13. Presence and/or history of immunodeficiency.
- •14. Patient currently suffering from a clinically important systemic illness that is likely to result in deterioration of the patient’s condition or affect the patient’s safety during the study:
- •*poorly controlled congestive heart failure (NYHA = 3)
- •*BMI > 40
- •*poorly controlled diabetes (HbA1c > 7.5%)
- •*severe renal insufficiency (eGFR < 30 mL/min)
- •*chronic liver disease – ALT (alanine aminotransferase) > 66 U/L in females or > 80 U/L in males, AST (aspartate aminotransferase) > 82 U/L
- •*other clinically significant systemic illness, if considered relevant by the investigator
- •15. Patient suffers from hypothyroidism, defined as TSH (thyroid-stimulating hormone) elevation > 5.0 mIU/L, and/or FT4 levels < 0.7 ng/dL. Patients with corrected hypothyroidism are eligible for the study provided that treatment has been stable for 3 months before study entry.
- •16. Patient has valid diagnosis of a significant psychiatric illness such as schizophrenia, any type of psychotic
研究者
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