Patient- and care-related benefits of amyloid PET imaging (ENABLE) - PETAD01

Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V.0 个研究点目标入组 1,126 人开始时间: 2023年8月16日最近更新: 2024年7月22日

试验速览

暂无简介。

•Age = 50 years, Accompaniment by an informant authorised/qualified to provide information, Patients with valid insurance cover from a German compulsory health insurance, Mild to moderate dementia syndrome, Clinical Dementia Rating Scale (CDR) > 0.5 and < 3.0, Mini-Mental-Status Test (MMSE) > 10, Unclear diagnosis of dementia or uncertain diagnosis of Alzheimer's disease (diagnostic certainty < 85 %), Diagnosis of Alzheimer's disease with at least 15% probability, i.e. Alzheimer's disease cannot be ruled out with certainty., No diagnosis possible by examination of the CSF because a) the patient has a contraindication for CSF puncture, b) the patient refuses CSF puncture or c) an unclear diagnosis remains after CSF puncture., Patients who would agree in principle to undergo amyloid PET diagnostics and are willing to know its result, if they are randomised into the amyloid PET arm., Written informed consent, either by the patient or the legal representative according to the presumed will of the patient.

•Severe dementia (CDR score = 3 and/or an MMST score =10)., Mild cognitive impairment, CDR score less than 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 PET scan (for women who are less than 12 months postmenopausal, a pregnancy test is done before the PET scan is performed)., Patients currently enrolled in another clinical trial with investigational product or within 5 half-lives of the investigational product of another clinical trial.

发起方

Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V.