EUCTR2015-000630-30-DE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 starting at screening and continuing throughout the study period. Appropriate contraception methods for females are detailed in chapter 4.1 of the Recommendations related to contraception and
- •pregnancy testing in clinical trials” (CTFG 2014); in addition, condoms are to be used by the male partner as described in Annex 3 of the protocol
- •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 disorder or bipolar affectiv
研究者
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