Alzheimer's Disease, Dementia, Mild Cognitive Impairment
Conditions
Keywords
Mild cognitive impairment, Alzheimer, PET, Amyloid, Frontotemporal
Brief 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.
Interventions
DRUGFlutemetamol (Vizamyl)
PET-MR Scan using the radiotracer Flutemetamol (Vizamyl) for diagnostic purpose
Sponsors
ETH Zurich
University of Zurich
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Other
| Measure | Time frame |
|---|---|
| Change from pre-treatment assessment on the decision regret scale after three months | Three 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 |
| Change from pre-treatment assessment on the decision regret scale after six months | 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 |
| 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 | Six Months after initiation of standard treatment |
Countries
Switzerland
Outcome results
None listed