EUCTR2015-005263-16-CZ进行中（未招募）1 期
A 6-months prospective, multi-center, double-blind, placebocontrolled,randomized, adaptive-trial-design study to evaluatesafety, tolerability and exploratory endpoints of either placebo ortwo different oral doses of LM11A-31-BHS in patients with mild tomoderate probable Alzheimer’s disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 180
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. Men and women (non-childbearing potential) with a diagnosis of Alzheimer’s disease according to McKhann (2011) criteria
- •2. Age 50-85 years (50-80 in Czech Republic)
- •3. MRI or CT assessment within six months before baseline, corroborating the clinical diagnosis of AD and excluding other potential causes of dementia, especially cerebrovascular lesions (see exclusion criteria, number 3)
- •4. CSF AD specific biomarker profile; positive, defined as CSF Aß42 <550 ng l-1 or a Aß 40/42 ratio < 0,89.
- •5. Mild to moderate stage of Alzheimer’s disease according to MMSE =18 and =26
- •6. Absence of major depressive disease according to GDS of < 5
- •7. Modified Hachinski Ischemic Scale =4
- •8. Formal education for eight or more years
- •9. Previous decline in cognition for more than six months as documented in patient medical records
- •10. Patients with moderate Alzheimer’s Disease must have a caregiver available and living in the same household. Patients with mild AD must have a caregiver either living in the same household or a caregiver interacting with the patient, providing personal care for the patient during at least 10 hours per week and available if necessary to assure administration of drug
- •11. Patients living at home or nursing home setting without continuous nursing care
- •12. General health status acceptable for a participation in a 6-month clinical trial
- •13. Ability to swallow capsules
- •14. Stable pharmacological treatment of any other chronic condition for at least one month prior to screening
- •15. Stable treatment with one of the acetylcholinesterase inhibitors donepezil (Aricept ®), galantamine (Razadyne®), or rivastigmine (Exelon) or the partial NMDA receptor antagonist with memantine (Namenda®) at least 3-months before baseline Visit or Combination of both treatments mentioned above
- •16. No regular intake of prohibited medications as noted in Section 11.8. of the protocol
- •17. Signed informed consent by the patient (in Germany and Czech Republic, examined and verified to be mentally capable by an independent physician/ neurologist) prior to the initiation of any study specific procedure. Signed consent of the caregiver (see inclusion criteria 10).
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •1. Failure to perform screening or baseline examinations
- •2. Hospitalization or change of chronic concomitant medication one month prior to screening or during screening period
- •3. Clinical, laboratory or neuro-imaging findings consistent with:
- •Other primary degenerative dementia, (dementia with Lewy bodies, fronto-temporal dementia, Huntington’s disease, Creutzfeldt-Jakob Disease, Down's syndrome, etc.)
- •Other neurodegenerative condition (Parkinson’s disease, amyotrophic lateral sclerosis, etc.)
- •Cerebrovascular disease (major infarct, one strategic or multiple lacunar infarcts, extensive white matter lesions > one quarter of the total white matter)
- •Other central nervous system diseases (severe head trauma, tumors, subdural hematoma or other space occupying processes, etc.)
- •Seizure disorder
- •Other infectious, metabolic or systemic diseases affecting central nervous system (syphilis, present hypothyroidism, present vitamin B12 or folate deficiency, serum electrolytes out of normal range, juvenile onset diabetes mellitus, etc.)
- •4. A current DSM-IV diagnosis of active major depression, schizophrenia or bipolar disorder
- •5. Clinically significant, advanced or unstable disease that may interfere with primary or secondary variable evaluations, and which may bias the assessment of the clinical or mental status of the patient or put the patient at special risk, such as:
- •Chronic liver disease, liver function test abnormalities or other signs of hepatic insufficiency (ALT, AST, Gamma GT, alkaline phosphatase > 2.5 ULN)
- •Respiratory insufficiency
- •Renal insufficiency (serum creatinine >2mg/dl) or creatinine clearance = 30 mL/min according to Cockcroft-Gault formula. In case of creatinine clearance =30mL/min, an alternative verification of the renal function must be completed using Cystatin C analysis. In case of normal level of Cystatin C, the patient can be included
- •Heart disease (myocardial infarction, unstable angina, heart failure, Cardiomyopathy within six months before screening)
- •Bradycardia (heart beat <50/min.) or tachycardia (heart beat >95/min.)
- •For Austria, Germany, Spain and Sweden: Hypertension (>180/95) or hypotension (<90/60) requiring treatment with more than three drugs
- •For Czech Republic: Hypertension (>160/95) or hypotension (<90/60) requiring treatment with more than three drugs
- •AV block (type II / Mobitz II and type III), congenital long
- •AV block (type II / Mobitz II and type III), congenital long QT syndrome, sinus node dysfunction or prolonged QTcB-interval (males >450 and females >470 msec)
- •.Uncontrolled diabetes defined by HbA1c >8.5
- •Malignancies within the last five years except skin malignancies (other than melanoma) or indolent prostate cancer
- •Metastases
- •6. Disability that may prevent the patient from completing all study requirements (e.g. blindness, deafness, severe language difficulty, etc.)
- •7. Women who are fertile and of childbearing potential
- •8. Chronic daily drug intake of = 14 days or expected for = 14 days:
- •benzodiazepines (except lorazepam = 1mg for sleeping disorders only), neuroleptics or major sedatives
- •Antiepileptics
- •Centrally active anti-hypertensive drugs (clonidine, l-methyl DOPA, guanidine, guanfacine, etc.)
- •Opioid containing analgesics
- •9. Nootropic drugs (except Ginkgo Biloba)
- •10. Austria, Germany, Spain and Sweden: Suspected or known drug or alcohol abuse, i.e. more than approximately 60 g alcohol (approximately 1 liter of beer o
研究者
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