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Taking people in GermanyPhase 4

Testing amyloid PET scans in people with dementia

Compares amyloid PET brain imaging with standard dementia tests in adults 18 and older.

Key facts

Who runs it
Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V.
Where
Berlin, Bonn, Cologne, Dresden, Erlangen, Essen, Freiburg im Breisgau, Goettingen, Greifswald, Hamburg, Leipzig, Magdeburg, Mainz, Mannheim, Marburg, Munich, Rostock, Tuebingen, and Ulm, GermanySee the 22 sites
Trial code
Registry title
Patient- and care-related benefits of amyloid PET imaging (ENABLE)
Status
Recruiting
Phase
Phase 4
People taking part
1,126 people, planned
Started
19 Aug 2024
Expected to end
31 Jan 2031
Type of study
Interventional
Record updated
17 July 2026

Who can take part

AI summary

From the trial's eligibility criteria. 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

The registry criteria, word for word

Show all 16 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)

Where in Germany

  • Charite Universitaetsmedizin Berlin KöRBerlin, GermanyTaking people
  • Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V.Bonn, GermanyTaking people
  • University Hospital Cologne AöRCologne, GermanyTaking people
  • Technische Universität DresdenDresden, GermanyTaking people
  • University Of Erlangen NurembergErlangen, GermanyTaking people
  • Universitaetsklinikum Essen (AoR)Essen, GermanyTaking people
  • Medical Center- University of FreiburgFreiburg im Breisgau, GermanyTaking people
  • Universitaetsmedizin GoettingenGoettingen, GermanyTaking people
  • Universitaetsmedizin Greifswald KöRGreifswald, GermanyTaking people
  • University Medical Center Hamburg-EppendorfHamburg, GermanyTaking people
  • Universitaet LeipzigLeipzig, GermanyTaking people
  • Universitaetsklinikum Magdeburg AöRMagdeburg, GermanyTaking people
  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöRMainz, GermanyTaking people
  • Central Institute of Mental HealthMannheim, GermanyTaking people
  • Universitaetsklinikum Mannheim GmbHMannheim, GermanyTaking people
  • Philipps University MarburgMarburg, GermanyTaking people
  • Universitaetsklinikum Giessen und Marburg GmbHMarburg, GermanyTaking people
  • Klinikum der Universitaet Muenchen AöRMunich, GermanyTaking people
  • Klinikum rechts der Isar der TU Muenchen AöRMunich, GermanyTaking people
  • Rostock University Medical CenterRostock, GermanyTaking people
  • Universitaetsklinikum Tuebingen AöRTuebingen, GermanyTaking people
  • Universitaetsklinikum Ulm AoRUlm, GermanyTaking people

About the trial

What the trial wants to find out

Demonstrate a patient-relevant benefit of amyloid PET compared to S3 guideline diagnostics without amyloid PET on dementia-relevant morbidity endpoints.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Patient- and care-related benefits of amyloid PET imaging (ENABLE)
Plain-language title
Testing amyloid PET scans in people with dementiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
17 July 2026