Patient- and care-related benefits of amyloid PET imaging (ENABLE)
Key facts
- Where
- Berlin, Bonn, Cologne, Dresden, Erlangen, Essen, Freiburg im Breisgau, Goettingen, Greifswald, Hamburg, Leipzig, Magdeburg, Mainz, Mannheim, Marburg, Munich, Rostock, Tuebingen és Ulm, NémetországSee the 22 sites
- Phase
- 4. fázis
Where in Németország
- Charite Universitaetsmedizin Berlin KöRBerlin, NémetországTaking people
- Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V.Bonn, NémetországTaking people
- University Hospital Cologne AöRCologne, NémetországTaking people
- Technische Universität DresdenDresden, NémetországTaking people
- University Of Erlangen NurembergErlangen, NémetországTaking people
- Universitaetsklinikum Essen (AoR)Essen, NémetországTaking people
- Medical Center- University of FreiburgFreiburg im Breisgau, NémetországTaking people
- Universitaetsmedizin GoettingenGoettingen, NémetországTaking people
- Universitaetsmedizin Greifswald KöRGreifswald, NémetországTaking people
- University Medical Center Hamburg-EppendorfHamburg, NémetországTaking people
- Universitaet LeipzigLeipzig, NémetországTaking people
- Universitaetsklinikum Magdeburg AöRMagdeburg, NémetországTaking people
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöRMainz, NémetországTaking people
- Central Institute of Mental HealthMannheim, NémetországTaking people
- Universitaetsklinikum Mannheim GmbHMannheim, NémetországTaking people
- Philipps University MarburgMarburg, NémetországTaking people
- Universitaetsklinikum Giessen und Marburg GmbHMarburg, NémetországTaking people
- Klinikum der Universitaet Muenchen AöRMunich, NémetországTaking people
- Klinikum rechts der Isar der TU Muenchen AöRMunich, NémetországTaking people
- Rostock University Medical CenterRostock, NémetországTaking people
- Universitaetsklinikum Tuebingen AöRTuebingen, NémetországTaking people
- Universitaetsklinikum Ulm AoRUlm, NémetországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V.
- Trial code
- EU 2023-503705-10-00
- Record updated
- 2026. július 17.
- Original description
Demonstrate a patient-relevant benefit of amyloid PET compared to S3 guideline diagnostics without amyloid PET on dementia-relevant morbidity endpoints.Read full original descriptionShow less
Demonstrate a patient-relevant benefit of amyloid PET compared to S3 guideline diagnostics without amyloid PET on dementia-relevant morbidity endpoints.
Inclusion: 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.
Exclusion: Patients in whom radiation exposure must be avoided; Patients enrolled in another clinical trial with investigational product at the time of inclusion or within 5 half-lives of the investigational product of another clinical trial; 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; 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).