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Insufficient Recruitment
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| Name | Class |
|---|---|
| ETH Zurich | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flutmetamol Group | Experimental | PET-MR-Scan with 80-140 MBq Flutemetamol before observational period for diagnostic purpose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flutemetamol (Vizamyl) | Drug | PET-MR Scan using the radiotracer Flutemetamol (Vizamyl) for diagnostic purpose |
|
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparisons of change from pre-treatment assessment of ADAS-Cog-11 after 6 months in clinical constellations defined by clinical diagnosis and Flutemetamol-status | Six Months after initiation of standard treatment | |
| Comparisons of change from pre-treatment assessment of ADCS-ADL after 6 months in clinical constellations defined by clinical diagnosis and Flutemetamol-status |
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
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
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Hock, MD, Prof. | University of Zurich, Institute for Regenerative Medicine, Center for Prevention and Dementia Therapy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Zurich, Institute for Regenerative Medicine, Center for Prevention and Dementia Therapy | Schlieren | Canton of Zurich | 8952 | Switzerland |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| C581552 | flutemetamol |
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| 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 |
| Six Months after initiation of standard treatment |
| Comparisons of change from pre-treatment assessment of MMSE after 6 months in clinical constellations defined by clinical diagnosis and Flutemetamol-status | Six Months after initiation of standard treatment |
| Comparisons of change from pre-treatment assessment of ADCS-CGIC after 6 months in clinical constellations defined by clinical diagnosis and Flutemetamol-status | Six Months after initiation of standard treatment |
| Change from pre-treatment assessment on the decision regret scale after three months | Three Months after initiation of standard treatment |
| Change from pre-treatment assessment on the decision regret scale after six months | Six Months after initiation of standard treatment |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |