Patient- and care-related benefits of amyloid PET imaging - ENABLE

Deutsches Zentrum für Neurodegenerative Erkrankungen e. V.0 个研究点目标入组 1,126 人开始时间: 2022年12月19日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Mild to moderate dementia syndrome.
•- Clinical Dementia Rating Scale (CDR-SB) greater than 0.5 and less than 3.0 and Mini-Mental Status Examination (MMSE) greater than 10
•- Unclear diagnosis of dementia or uncertain diagnosis of Alzheimer's disease (diagnostic certainty less than 85 percent).
•- At least 15 percent probability of Alzheimer's disease, i.e., Alzheimer's disease cannot be excluded with certainty.
•- Diagnosis by examination of the cerebrospinal fluid is not possible because a) the patient has a contraindication to CSF puncture, b) the patient refuses CSF puncture or c) the diagnosis remains unclear after CSF puncture.
•- Patients who would agree in principle to undergo amyloid PET diagnostics and are willing to receive the results if randomised to the amyloid PET arm.
•- Written informed consent, either by the patient or the legal representative according to the presumed will of the patient
•- Accompanied by an authorised/qualified informant
•- Patients with valid insurance cover from a German statutory health insurance company

•- Severe dementia (CDR score equal to 3 and/or an MMST score less than or equal to 10).
•- Mild cognitive impairment, CDR score less than or equal to 0.5, absence of cognitive impairment relevant to daily living
•- Patients in whom radiation exposure must be avoided
•- Pregnancy or breastfeeding at the time of the amyloid PET measurement (for women who are less than 12 months postmenopausal, a pregnancy test is carried out before the amyloid PET-measurement)
•- Patients who are currently participating in another clinical trial with investigational medication or within 5 half-lives of the investigational medication of another clinical trial

发起方