NL-OMON33961已完成不适用
Open-label, non-randomized, positron emission tomography (PET) imaging study to evaluate a single dose of 250 MBq (6.75 mCi) ZK 6032924 (18F-FEDAA1106) for its diagnostic potential in discriminating patients with probable Alzheimerâ¤*s disease from healthy volunteers and to evaluate the radiation dosimetry of a single dose of 185 MBq (5 mCi) ZK 6032924 in healthy volunteers. - PET Study with ZK6032924 in probable AD patients vs HV.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Healthy volunteers for brain imaging
- •1.Healthy volunteer for brain imaging is able to understand the information provided on purpose and conduct of the clinical study, must be capable of giving fully informed consent in writing, and has read and signed the informed consent prior to study participation.
- •2.Healthy males and post-menopausal females aged * 50 years (the age difference between a patient and the age-matched volunteer should not be larger than 5 years; a larger difference in age will be allowed if adherence to this rule causes significant slowing of healthy volunteer recruitment rate) and BMI within the range (19 * BMI * 30).
- •3.Female postmenopausal status will be determined by medical history (last spontaneous bleeding at least 1 year prior to radiotracer administration or females must have had a hysterectomy or a bilateral oophorectomy at least three months prior to radiotracer administration). In addition, females must have serum follicle-stimulating hormone (FSH) levels * 40 mIU/mL and estradiol level * 20 pg/mL.
- •4.MMSE score of * 28
- •5.CDR score of zero (0)
- •6.Confirmation by other neuropsychological test results that the volunteer does not show any signs of cognitive impairment or dementia (e.g. results lying within an interval of one standard deviation from the mean value, mean value and standard deviations adjusted for age and education)
- •7.Adequate visual and auditory acuity to complete neuropsychological testing; Probable Alzheimer*s disease patients for brain imaging
- •1.Patient and designee must be able to understand the information provided on purpose and conduct of the clinical study, must be capable of giving fully informed consent in writing, and have read and signed the informed consent prior to study participation.
- •2.Males and postmenopausal females aged * 50 years and BMI within the range (19 * BMI * 30)
- •3.Female postmenopausal status will be determined by medical history (last spontaneous bleeding at least 1 year prior to radiotracer administration or females must have had a hysterectomy or a bilateral oophorectomy at least three months prior to radiotracer administration). In addition, females must have serum follicle-stimulating hormone (FSH) levels * 40 mIU/mL and estradiol level * 20 pg/mL.
- •4.Patient fulfills DSM-IV and NINCDS-ADRDA criteria for probable AD
- •5.Patient has mild to moderate dementia :
- •a.with a dementia score between ³ 20 on the Mini-Mental Status Examination (MMSE)
- •b.with a Clinical Dementia Rating score of 1 or 2 (CDR)
- •6.Patient has had the following further tests within the 120 days preceding radiotracer administration:
- •- Neurological examination
- •- Psychometric testing
- •- Brain MRI
- •7.Adequate visual and auditory acuity to complete psychometric testing
排除标准
- •probable Alzheimer*s disease 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 and any other from of dementias different from AD (e.g. Lewy Body dementia, Fronto temporal dementia or vascular dementia)
- •2.Lifetime history of major affective disorder, schizophrenia, schizoaffective disorder
- •3.MRI brain scan findings that do not reveal changes indicative of stroke and/or generalized cerebrovascular disease (e.g., the ARWMC scale) changes limited to: a white matter lesion score of 0 or 1 or 2 and a basal ganglia score of 0 or 1); healthy volunteers for brain imaging and probable AD patients
- •1.Any disease, condition, or concomitant medications that significantly compromises the function of the body systems and could result in excessive accumulation, impaired metabolism, altered excretion of the radiotracer, or might interfere with the conduct of the study or interpretation of the results.
- •2.History of significant occupational exposure to ionizing radiation or application of
- •radioactive substances or ionizing radiation for the purposes of diagnosis or
- •treatment within the last year (> 10 mSv for healthy volunteers and > 50 mSV for
- •AD patients within one year) or application of radioactive substances or ionizing
- •exposure to radiation during an investigation / study in the year preceding the PET scan or whose occupational exposure to radioactivity is monitored.
- •3.Haematological or biochemical parameters that are outside the normal range and are considered clinically significant by the investigator.
- •4.History of or current alcohol or drug abuse/dependence.
- •5.History of major allergic reactions.
- •6.History of epilepsy.
- •7.History of electroconvulsive therapy.
- •8.Current 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).
- •9.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.
- •10.Subjects in whom magnetic resonance imaging (MRI) is contraindicated or receipt of any contrast material (X-ray, MRI) or radiopharmaceuticals within 48 hours or 5 half lives prior to the application of the radiotracer or if application of such a substance is planned during the observation period.
- •11.Receiving drug therapy with known significant action on the CNS such as NSAIDs (within 24 hours), aspirin (within 12 hours), or benzodiazepines, corticosteroids, vinpocetine, vincamine and other eburnamine derivatives, within 5 half-lives of the respective drug before radiotracer administration. The intake of typical medication of the treatment of probable AD with no evidence of interfering with the peripheral benzodiazepine receptor expression in the central nervous system, such as Donepezil or similar compounds. May be continued during the study.
- •12.Donation of blood within 4 weeks or plasmapheresis within 2 weeks before the radiotracer administration.
- •13.Current systemic autoimmune disease or clinically relevant systemic inflammatory disease.
- •14.History of brain surgery, in
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