NL-OMON47767已完成4 期
The clinical prognostic value of amyloid imaging with [18F]AV-45 in a subjects with subjective complaints - Clinical prognostic value [18F]AV-45
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 280
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
- •- age >45
- •- Written informed consent
- •- Weight >50 kg , - Able to tolerate 70-minute scanning
- •- No objective cognitive impairment (i.e. no diagnosis of dementia, mild cognitive impairment, psychiatric or neurological disorder explaining cognitive complaints).
- •- MMSE ><= 18
排除标准
- •Patients who
- •1. Have a current a major psychiatric disorder, such as psychosis, schizophrenia, severe personality disorder or depression with vital signs, abuse of alcohol or other substances. Or patients who have a neurological disorder, such as Parkinson's disease, symptomatic stroke, mental retardation.
- •2. Are women of childbearing potential who are not surgically sterile, not refraining
- •from sexual activity or not using reliable methods of contraception. Women of
- •childbearing potential must not be pregnant (negative urine *-hCG at the time of
- •screening and negative urine *-hCG on the day of imaging) or breast feeding at
- •screening. Women must avoid becoming pregnant, and must agree to refrain from
- •sexual activity or to use reliable contraceptive methods such as prescribed birth
- •control or IUD for 24 hours following administration of florbetapir (18F);
- •3. Have a relevant history of severe drug allergy or hypersensitivity (relevant severe
- •drug allergies should be determined by the Principal Investigator or Co-Principal
- •Investigator, and any questions about a subject*s eligibility can be directed to Avid
- •Radiopharmaceuticals Inc. If a subject has a history of severe drug allergies, it may be
- •dangerous for them to participate in a study with a novel compound);
- •4. Have ever participated in an experimental study with an amyloid targeting agent (e.g. anti-amyloid immunotherapy, *-secretase or *-secretase inhibitor) unless it can be documented that the subject received no investigational medication (yet) or only placebo during the course of the trial;
- •5. Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior
- •to the study imaging session.
研究者
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