EUCTR2009-012569-79-DE进行中（未招募）1 期
An open-label, non-randomized study to evaluate the efficacy and safety of BAY 94-9172 (ZK 6013443) positron emission tomography (PET) imaging for detection/exclusion of cerebral ß-amyloid when compared to postmortem histopathology - Safety and efficacy of positron emission tomography imaging with BAY 94-9172 (ZK 6013443)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer AG
- 入组人数
- 250
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
- •Subjects with a low probability of cerebral ß-amyloid deposition, e.g. non-demented volunteers and subjects with a high probability of ß-amyloid deposition, e.g.patients diagnosed with AD or Dementia with Lewy Bodies (DLB), 10 cognitively normal and young healthy volunteers between 21 and 40 years of age.
- •Each study participant has to meet the following criteria:
- •- is at least 21 years of age
- •- females, no child-bearing potential or negative urine pregnancy test on day of BAY 94-9172 injection
- •- exhibits visual, auditory, and communicative capabilities adequate to provide informed consent or assent and comply with study procedures
- •- is willing and able to lie down in MRI and PET scanners
- •- is willing to donate their brain for postmortem examination in case of death (this consent can be obtained in the manner specific to the country/region involved and is not required of the 10 young healthy volunteer study participants)
- •- the subject, or the subject and its legally acceptable representative (e.g., for probable AD and DLB patients), will be compliant and have a high probability of completing the study in the opinion of the investigator
- •- has been fully informed about the study, including provisions of the Health Insurance Portability and Accountability Act (HIPAA), as applicable, and informed consent or assent has been signed and dated (with time) by the subject and/or the subject's legally acceptable representative (e.g., for probable AD and DLB patients)
- •- the subject who has participated in a previous florbetaben study eg, study 311741, may be included in the present study. The MRI- and florbetaben PET scan do not need to be repeated if both scans were performed within twelve months prior to inclusion.
- •Inclusion criteria for the additional 10 negative controls only
- •- is = 21 to = 40 years of age
- •- has no evidence of cognitive impairment as indicated by a clinical dementia rating (CDR, Hughes et al, 1982) score of 0 (zero) and a score of = 28 in the Mini-Mental Status Examination (MMSE, Folstein et al, 1975)
- •- has no evidence of cognitive impairment as indicated by the CERAD neuropsychological test battery based on the results of each of the subtests (except MMSE which is covered by criterion 9 above)
- •- has MRI brain scan that has been judged as normal (age-appropriate) including ARWMC scale (Wahlund et al, 2001) scores supporting the lack of cerebrovascular disease (e.g., a white matter lesion score of 0 or 1 or 2 and a basal ganglia score of 0 or 1) and a Scheltens scale (Scheltens et al, 1992) verifying the lack of cerebral atrophy (e.g., bilateral temporal lobe atrophy visual score of 0 or 1).
- •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 42
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 174
排除标准
- •Each subject who meets any of the following criteria must not participate in this study:
- •- has severe cerebral macrovascular (i.e., multi-stroke) disease or brain tumor (metastasis/brain cancer) as verified by MRI
- •- has any contraindication to magnetic resonance imaging (MRI) examination, e.g. metal implants or phobia as determined by the onsite radiologist performing the scan
- •- is scheduled for surgery and/or another invasive procedure within the time period of up to 7 days following study drug administration
- •- is allergic to the study drug or any of its constituents
- •- has received any contrast material (X-ray, MRI) or radiopharmaceutical within 48 hours prior to or a therapeutic radiopharmaceutical (e.g. 131I) within 10 days prior to the administration of the study drug or for whom administration of such substances is planned within 7 days following study drug administration
- •- has been previously enrolled in this study or participated in a clinical study involving an investigational pharmaceutical product within 30 days prior to treatment and/or was administered a radiopharmaceutical within 10 radioactive half-lives to study drug administration in this study*
- •- has severe cardio-vascular instability requiring intensive care surveillance and/or therapeutic intervention (i.e., catecholamine infusion)
- •*NOTE for subjects in Germany only: According to the German Radiation Protectin Law, subjects in Germany with a low probability of cerebral ß-amyloid deposition in the brain are not allowed to receive more than 10 mSv of radiation within a 10 year period and therefore will undergo the initial PET scan only; the yearly follow-up PET scans are prohibited.
研究者
相似试验
进行中（未招募）
1 期
An open-label, non-randomized study to evaluate the efficacy and safety of BAY 94-9172 (ZK 6013443) positron emission tomography (PET) imaging for detection/exclusion of cerebral ß-amyloid when compared to postmortem histopathology - Safety and efficacy of positron emission tomography imaging with BAY 94-9172 (ZK 6013443)Detection/Exclusion of cerebral ß-amyloid.To determine the sensitivity and specificity of the visual assessment of regional tracer uptake in the BAY 94-9172 PET images compared to histological verification of the presence or absence of cerebral ß-amyloid in the respective postmortem specimens as the standard of truth.MedDRA version: 9.1Level: LLTClassification code 10001896Term: Alzheimer's diseaseEUCTR2009-012569-79-FRBayer HealthCare AG218
尚未招募
不适用
An Open Label, Non-randomised study to evaluate the safety, efficacy, tolerability and compliance of the Tongue Tamer Mandibular Advancement Splint in patients with Obstructive Sleep ApnoeaObstructive Sleep ApnoeaRespiratory - Sleep apnoeaACTRN12615000037505Prof. Peter Cistulli15
进行中（未招募）
1 期
A clinical trial to evaluate the effect of OTL-200, a gene therapy treatment in patients with Late Juvenile (LJ) Metachromatic Leukodystrophy (MLD)Metachromatic Leukodystrophy (MLD) is an autosomal recessive disorder caused by mutationsMedDRA version: 20.0Level: PTClassification code: 10067609Term: Metachromatic leukodystrophy Class: 100000004850CTIS2024-511971-13-00Orchard Therapeutics (Europe) Limited6
进行中（未招募）
1 期
A clinical trial to evaluate the effect of OTL-200, a gene therapy treatment in patients with Late Juvenile (LJ) Metachromatic Leukodystrophy (MLD)EUCTR2019-002636-82-ITOrchard Therapeutics (Europe) Limited6
进行中（未招募）
3 期
An Open-Label, Non-Randomized Study to Assess the Safety and Efficacy of Leniolisib in Japanese Patients With Activated Phosphoinositide 3-Kinase Delta Syndrome (APDS) Followed By an Open-Label Long-Term ExtensioJPRN-jRCT2061230036Bradt Jason3