EUCTR2008-003597-18-GB进行中（未招募）1 期
A study evaluating the imaging characteristics of 18F-AV-45 in patients with frontotemporal dementia compared to patients with Alzheimer's disease and normal controls
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
入选标准
- •Patients may be enrolled in the probable AD group if they:
- •Are at least 50 years old (male or female);
- •Subjects whose history of cognitive decline has been gradual in onset and progressive over a period of at least 6 months.
- •Meet the National Institute of Neurological and Communication Disorders and Stroke (NINCDS) criteria for probable AD and have a Mimi Mental State Examination (MMSE) score at screening between 10 and 24 inclusive;
- •Have a caregiver who can report on their mental status and activities of daily living (ADL); and
- •Give informed consent. If the patient is incapable of giving informed consent, the caregiver may consent on behalf of the patients (the patient must still confirm assent).
- •Patients may be enrolled in the FTD group if they;
- •Are at least 45 years old (male or female);
- •Meet the consensus criteria for FTD (Neary, Snowden et al., 2005) and have mild to moderate disease with the clinical phenotype of behavioural-disexecutive FTD;
- •Have a caregiver who can report on their mental status and ADL; and
- •Give informed consent. If the patient is incapable of giving informed consent, the caregiver may consent on behalf of the patients (the patient must still confirm assent).
- •Subjects may be enrolled in the cognitively normal volunteer group if they:
- •Are at least 45 years old (male or female);
- •Have an MMSE score = 29 and are cognitively normal by informant report and on the psychometric test battery at screening; and
- •Give informed consent.
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •History of or current clinically significant neurological disease other then AD or FTD;
- •Previous or current diagnosis of other dementing/neurodegenerative disease (Parkinson’s disease, dementia with Lewy bodies, Lewy body variant AD etc);
- •Previous or current diagnosis of mixed dementia;
- •Evidence (eg MRI, other biomarkers) suggesting dementia other than AD or FTD (or in cognitively normal volunteers any suggestion of AD or FTD) or other neurological pathology (eg stroke, head trauma etc);
- •Current clinically significant cardiovascular disease or abnormalities on screening ECG;
- •Current clinically significant psychiatric disease;
- •Current clinically significant endocrine or metabolic disease, pulmonary, renal or hepatic impairment or cancer;
- •Clinical significant infectious disease;
- •Recent history of alcohol or substance abuse or dependence;
- •Women of childbearing potential who are not surgically sterile or are not refraining from sexual activity while not using reliable methods of contraception;
- •Require medicines with narrow therapeutic window;
- •Previous participation in a study with amyloid targeting agent;
- •Radiopharmaceutical imaging or treatment within 7 days of the day of imaging.
研究者
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