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Patient- and care-related benefits of amyloid PET imaging (ENABLE)
EU CTIS ID: 2023-503705-10-00
What this study is testing
Demonstrate a patient-relevant benefit of amyloid PET compared to S3 guideline diagnostics without amyloid PET on dementia-relevant morbidity endpoints.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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 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.
See the full eligibility criteria
- 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 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.