Overview

Investigating the Clinical Consequences of Flutemetamol-PET-scanning

Status:
Terminated
Trial end date:
2019-12-10
Target enrollment:
0
Participant gender:
All
Summary
The study examines subjects where there might be an indication for Amyloid-PET according to the Criteria defined by the Amyloid Imaging Task Force. In these subjects the impact of a Flutemetamol (Vizamyl)-Positron-Emission-Tomography -Scan (PET) on clinical management and disease course will be studied over 6 months.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Zurich
Collaborator:
ETH Zurich
Treatments:
Flutemetamol
Criteria
Inclusion Criteria:

- Dementia expert considers an Amyloid-scan appropriate according to Amyloid-imaging
task force criteria (AIT) after conference with an Amyloid-PET expert

- Preambles of the AIT-Criteria are fulfilled

1. A cognitive complaint with objectively confirmed impairment

2. AD as a possible diagnosis, but when the diagnosis is uncertain after a
comprehensive evaluation by a dementia expert

3. When knowledge of the presence or absence of Abeta pathology is expected to
increase diagnostic certainty and alter Management

1. Patients with persistent or progressive unexplained MCI

2. Patients satisfying core clinical criteria for possible AD because of unclear
clinical presentation, either an atypical clinical course or an etiologically
mixed presentation

3. Patients with progressive dementia and atypically early age of onset (65 years or
less in age)

4. other situations where preambles of AIT-Criteria are fulfilled

- Diagnosis was established in a memory clinic or by an experienced physician in
dementia diagnostics

- The diagnostic procedures comprise in minimum MRI, neuropsychology, routine blood test
for exclusion of symptomatic causes

- MMSE >15

- Competency to consent

- Trial partner willing to support study physician

- Written informed consent by both patient and trial partner

- Understanding of German language

- Treating physician willing to collaborate with the study team

Exclusion Criteria:

- Cognitive impairment which can be attributed to another underlying medical condition
that renders a possibility of Alzheimer's disease very unlikely (thus violating
preamble B)

- Clinically significant Depression (decided upon clinical assessment)

- MRI exclusion criteria

- PET exclusion criteria

1. Allergy to Flutemetamol or any of the excipients of the solution for injections

2. History of severe allergic reactions to drugs or allergens

3. Pregnancy or lactation