2023-503705-10-00RecruitingPhase 4
Patient- and care-related benefits of amyloid PET imaging (ENABLE)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 17 Jul 2026
Brief summary (registry, in English)
Demonstrate a patient-relevant benefit of amyloid PET compared to S3 guideline diagnostics without amyloid PET on dementia-relevant morbidity endpoints.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 1126 (estimated)
- First submitted
- 16 Aug 2023
- Start date
- 19 Aug 2024
- Lead sponsor
- Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V.
- EU CT number
- 2023-503705-10-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 1126
- 22 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 50 or older with mild to moderate dementia whose diagnosis is unclear or uncertain, and who come with an informant.
- Age
- 50 years or older
- Sex
- All sexes can join.
- Disease stage
- Mild to moderate dementia: CDR above 0.5 and below 3.0, and MMSE above 10. The diagnosis is unclear, or Alzheimer's disease cannot be ruled out with certainty.
- Biomarker or test result
- No clear diagnosis from a CSF test, because CSF puncture is not possible, is refused, or leaves the diagnosis unclear.
Main reasons for not taking part
- Severe dementia (CDR score 3 and/or MMSE score 10 or lower)
- Mild cognitive impairment or no cognitive impairment relevant to daily living
- Radiation exposure must be avoided
- Pregnancy or breastfeeding at the time of the PET scan
- Taking part in another trial with an investigational product
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
Other
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (22)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Charite Universitaetsmedizin Berlin KöR | Berlin | Germany | Recruiting |
| Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V. | Bonn | Germany | Recruiting |
| University Hospital Cologne AöR | Cologne | Germany | Recruiting |
| Technische Universität Dresden | Dresden | Germany | Recruiting |
| University Of Erlangen Nuremberg | Erlangen | Germany | Recruiting |
| Universitaetsklinikum Essen (AoR) | Essen | Germany | Recruiting |
| Medical Center- University of Freiburg | Freiburg im Breisgau | Germany | Recruiting |
| Universitaetsmedizin Goettingen | Goettingen | Germany | Recruiting |
| Universitaetsmedizin Greifswald KöR | Greifswald | Germany | Recruiting |
| University Medical Center Hamburg-Eppendorf | Hamburg | Germany | Recruiting |
| Universitaet Leipzig | Leipzig | Germany | Recruiting |
| Universitaetsklinikum Magdeburg AöR | Magdeburg | Germany | Recruiting |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR | Mainz | Germany | Recruiting |
| Central Institute of Mental Health | Mannheim | Germany | Recruiting |
| Universitaetsklinikum Mannheim GmbH | Mannheim | Germany | Recruiting |
| Philipps University Marburg | Marburg | Germany | Recruiting |
| Universitaetsklinikum Giessen und Marburg GmbH | Marburg | Germany | Recruiting |
| Klinikum rechts der Isar der TU Muenchen AöR | Munich | Germany | Recruiting |
| Klinikum der Universitaet Muenchen AöR | Munich | Germany | Recruiting |
| Rostock University Medical Center | Rostock | Germany | Recruiting |
| Universitaetsklinikum Tuebingen AöR | Tuebingen | Germany | Recruiting |
| Universitaetsklinikum Ulm AoR | Ulm | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.