Investigating the Clinical Consequences of Flutemetamol-PET-scanning

Study Overview
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Brief Summary
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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.

Official Title
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Investigating the Clinical Consequences of Flutemetamol-PET-scanning

Conditions
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Mild Cognitive Impairment, Alzheimer's Disease, Dementia

Intervention / Treatment
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* Drug: Flutemetamol (Vizamyl)


Participation Criteria
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Eligibility Criteria
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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 A cognitive complaint with objectively confirmed impairment AD as a possible diagnosis, but when the diagnosis is uncertain after a comprehensive evaluation by a dementia expert When knowledge of the presence or absence of Abeta pathology is expected to increase diagnostic certainty and alter Management Patients with persistent or progressive unexplained MCI Patients satisfying core clinical criteria for possible AD because of unclear clinical presentation, either an atypical clinical course or an etiologically mixed presentation Patients with progressive dementia and atypically early age of onset (65 years or less in age) 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 Allergy to Flutemetamol or any of the excipients of the solution for injections History of severe allergic reactions to drugs or allergens Pregnancy or lactation
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flutmetamol Group<br>PET-MR-Scan with 80-140 MBq Flutemetamol before observational period for diagnostic purpose | Drug: Flutemetamol (Vizamyl)<br>* PET-MR Scan using the radiotracer Flutemetamol (Vizamyl) for diagnostic purpose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of ADAS-cog 11 score compared to pre-treatment assessment in Flutemetamol positive subjects with a postscan diagnosis of AD and start of cholinesterase inhibitors as standard treatment. |  | Three months after initiation of standard treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of ADCS-ADL score compared to pre-treatment assessment in Flutemetamol positive subjects with a postscan diagnosis of AD and start of cholinesterase inhibitors as standard treatment. |  | Three months after initiation of standard treatment | 
| Change of ADCS-CGIC score compared to pre-treatment assessment in Flutemetamol positive subjects with a postscan diagnosis of AD and start of cholinesterase inhibitors as standard treatment. |  | Three months after initiation of standard treatment | 
| Change of MMSE score compared to pre-treatment assessment in Flutemetamol positive subjects with a postscan diagnosis of AD and start of cholinesterase inhibitors as standard treatment. |  | Three months after initiation of standard treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mild cognitive impairment, Alzheimer, PET, Amyloid, Frontotemporal