DRKS00005819已完成1 期
Validation of the new Positron Emissions Tomography (PET) Radioligand (+)-[18F]-Flubatine for Imaging of Nicotinic Acetylcholine Receptors (nAChR) in Alzheimer’s Dementia - +Flubatine
niversität Leipzig0 个研究点目标入组 34 人开始时间: 2014年4月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 55 Years 至 one（—）
- 性别
- All
入选标准
- •Healthy volunteers:
- •1. Males/females aged older than or equal to 55 years of age, females must be without childbearing potential (confirmed by either: age = 60; or history of hysterectomy; or hormone analysis in serum: Estradiol = 20 pg/mL and follicle stimulating hormone (FSH) = 40 IU/L, or last spontaneous bleeding at least 2 years prior to the study start)
- •2. Able to understand the information provided on purpose and conduct of the clinical study
- •3. Have signed the informed consent to participate in the study
- •4. No history of any psychiatric or neurological diseases. Clinical Dementia Rating (CDR) score of 0 (zero) and psychometric test results lying within an interval of one standard deviation from the mean value (mean value and standard deviations adjusted for age and education), for all subtests of the test battery applied.
- •5. Adequate visual and auditory abilities to complete neuropsychological testing, as assessed by the recruiting investigator
- •6. = 1 year no smoking or passive smoking
- •AD patients
- •1. Males/females aged older than or equal to 55 years of age; females must be without childbearing potential (confirmed by either: age = 60; or history of hysterectomy; or hormone analysis in serum: Estradiol = 20 pg/mL and follicle stimulating hormone FSH = 40 IU/L, or last spontaneous bleeding at least 2 years prior to the study start)
- •2. Capable of understanding the information provided on purpose and conduct of the clinical study and able to give meaningful informed consent by himself / herself
- •3. Have signed the informed consent to participate in the study
- •4. Adequate visual and auditory acuity to complete neuropsychological testing, as assessed by the recruiting investigator
- •5. AD patients, characterized by:
- •o Progressive cognitive decline with DSM-IV criteria for Dementia
- •o Probable Alzheimer Disease according to the NINCDS-ADRDA criteria
- •o Severity of dementia: mild, with a score of 1 on the Clinical Dementia Rating (CDR) and 20-26 on the Mini Mental State Examination (MMSE)
- •6. = 1 year no smoking or passive smoking
排除标准
- •All subjects:
- •1. Haematological or biochemical parameters that are outside the normal range and are considered clinically significant by the investigator.
- •2. History of alcohol or drug abuse/dependence
- •3. History of major allergic reactions
- •4. History of epilepsy
- •5. History of electroconvulsive therapy
- •6. Any significant disease or unstable medical condition (e.g. unstable angina, myocardial infarction or coronary revascularization in the preceding 12 months, cardiac failure, chronic renal failure, chronic hepatic disease, severe pulmonary disease, blood disorders, poorly controlled diabetes, chronic infection)
- •7. Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the volunteer’s safety
- •8. Participants in whom magnetic resonance imaging (MRI) is contraindicated.
- •9. Patient / Volunteer is in custody by order of an authority or a court of law
- •10. Exclusion periods from other studies or simultaneous participation in other clinical studies
- •11. Patient / Volunteer has received another investigational drug in the preceding 2 months
- •12. Previous enrollment in this study
- •13. Active Smokers
- •14. Interuption of central acting drugs less than 5 to 10 half lifes is not possible
- •15. Inadequate collateral circulation of the hand
- •AD patients:
- •1. History, physical or imaging findings of other neurological illness apart from AD such as cerebrovascular disease, inflammatory or infectious disease and other degenerative diseases or other types of dementia such as fronto-temporal lobe dementia or Lewy body disease.
- •Healthy volunteers:
- •1. Clinical significant abnormal physical examination
- •2. Evidence of any significant psychiatric or neurological illness from history, clinical or para – clinical findings
- •3. History, physical or imaging findings of any significant neurological illness such as cerebrovascular disease, inflammatory or infectious disease and other neurodegenerative diseases
- •4. Previous significant occupational exposure to ionizing radiation or in whom, within the last 10 years, radioactive substances or when ionizing radiation was applied for the purposes of research. (According to § 24 Abs. 1 Nr. 6 StrlSchV / § 28b Abs. 1 Nr. 6 RöV)
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