KCT0001785已完成未知
An Open Label, Multicenter Study for Evaluation of the Clinical Utility of [18F]THK-5351 Positron Emission Computed Tomography in Cognitively Healthy Volunteers, Subjects With Mild Cognitive Impairment, Subjects With Alzheimer’s Disease and Subjects With Other Neurodegenerative Diseases
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 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 Study
入排标准
- 年龄范围
- 40(Year) 至 79(Year)（—）
- 性别
- All
入选标准
- •General Subject Inclusion Criteria
- •1. Be = 40 and < 80 years of age at the Screening Visit.
- •2. Be able to read at a 6th grade level or equivalent, (as determined by the investigator, and must have a history of academic achievement and/or employment sufficient to exclude mental retardation.)
- •3. Be able to speak, read, hear, and understand the language of the trial staff, and the informed consent form, and possess the ability to respond verbally to questions, follow instructions, and complete questionnaires and detailed neuropsychological test.
- •4. Have results of clinical laboratory tests/physical examination, vital signs, and ECG within normal limits (at 90 days prior to [18F]THK-5351 PET scan ) or clinically acceptable to the investigator at screening.
- •5. Be able to possess the ability to respond verbally to questions, follow instructions, and underwent research assessment, including brain images based on the investigator's judgment. Each subject is also able and willing to adhere visit schedules.
- •6. If female, not be of childbearing potential as indicated by one of the following
- •7. Each subject (or legal representative) must sign the informed consent form in accordance with local requirements after the scope and nature of the investigation have been explained to them, and before screening assessments.
- •8. Each subject must be willing to provided blood samples for genotyping ApoE.
- •- Cognitively Healthy Subjects
- •- Mild Cognitive Impairment subjects
- •- Alzheimer’s Disease subjects
- •- Subjects with other neurodegenerative disease
排除标准
- •General Exclusion Criteria
- •-Based on the investigators’ judgement, if the patient is not capable of communicating with the site personnel, if the patient is not proficient in the language in which the psychometric tests will be completed, or if the patient is not sufficient for compliance with the study procedures.
- •-The patient has an abnormal physical examination or abnormal laboratory test results at the screening that are clinically significant to affect results of the research, as judged by the investigator.
- •-If the patient has or is suspicious of having a hypersensitivity or allergy to [18F] THK-5351 or its derivatives.
- •-The patient is pregnant, is attempting to become pregnant, or is nursing (breast-feeding) children.
- •-The patient has a history of alcoholism or drug dependency/abuse within the last 2 years before screening.
- •-The patient has contraindications to undergo PET or MRI, which include but are not restricted to the examples below: claustrophobia, cardiac pacemaker, metal devices around the eye or spinal cord, cochlear implant, etc.) at the screening visit.
- •-The patient has been treated with any investigational medicinal product (IMP) within 30 days prior to the screening visit.
- •-The patient has been tested positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), HIV Antibody, or syphilis serum test at the screening visit.
研究者
相似试验
未知
3 期
Open Label Study of Treatment With LCZ696 in Hypertensive Patients With Renal DysfunctioHypertensive Patients With Renal DysfunctionJPRN-jRCT2080221812ovartis Pharma K.K.28
未知
3 期
Open Label Study of Treatment With LCZ696 in Patients With Severe HypertensioSevere HypertensionJPRN-jRCT2080221859ovartis Pharma K.K.34
进行中（未招募）
1 期
Safety Study of Eteplirsen to Treat Early Stage Duchenne Muscular DystrophyEUCTR2016-005023-92-Outside-EU/EEASarepta Therapeutics, Inc.40
进行中（未招募）
1 期
Safety Study of Eteplirsen to Treat Advanced Stage Duchenne Muscular DystrophyEUCTR2016-005024-28-Outside-EU/EEASarepta Therapeutics, Inc.24
进行中（未招募）
不适用
Evaluation of Persistence of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received MenACWY Conjugate Vaccineovartis Meningococcal ACWY conjugate vaccine is intended for prevention of meningitis and septicemia caused by Neisseria meningitidis serogroups A, C, W and Y.EUCTR2014-004903-63-Outside-EU/EEAovartis Vaccines and Diagnostics Inc.825