NCT02958670 · ACTIVE NOT RECRUITING
Imaging Tau Deposition in the Brain of Elderly Subjects
This study uses a brain scan with a tracer called 18F-AV-1451 to see where tau protein builds up in older adults. Tau and amyloid are two proteins linked to Alzheimer's. Researchers want to know how tau relates to brain cell health and thinking ability. It is an imaging study, not a treatment test, so no phase applies.
Eligibility criteria
Inclusion Criteria: 1. Subject belongs to one of the following groups: * No cognitive impairment * Mild cognitive impairment according to Winblad et al., 2004 * Clinical diagnosis of dementia due to Alzheimer's disease compatible with DSM IV criteria or revised NINCDS-ADRDA criteria * Evidence of neurodegenerative disease other than AD 2. Written informed consent approved by the regulatory authorities 3. Age ≥ 50 years, women must be without childbearing potential 4. Pre-existing PET information (11C-Pittsburgh Compound B, 18F-Flutemetamol) on cerebral amyloid deposition 5. German speaking or sufficient knowledge of German language to perform study assessments 6. Subject is willing and able to name an informant who can give adequate information on the scales where informant input is required Exclusion Criteria: 1. Evidence for cognitive impairment mainly attributed to a non-neurodegenerative underlying medical condition (e.g. medication, brain tumor, severe heart insufficiency, hepatic encephalopathy) 2. Evidence of larger cerebral infarcts, or lacunes in critical memory structures 3. Disease or other condition with a potential to interfere with study participation 4. Ongoing infection with human immunodeficiency virus (HIV) or any hepatitis virus 5. Active, acute or chronic leukemia 6. Severe illness likely to cause disability that interferes with study procedures in the following years 7. Evidence of acute psychiatric disease (upon clinical decision) which may be a cause of cognitive impairment. Patients with a history of major depression under stable medication may be included. Patients with low dose intake of benzodiazepines may also be included upon clinician's decision 8. Previous or current participation in anti-beta-amyloid or anti-tau therapeutic trials 9. MR exclusion criteria 10. PET exclusion criteria 11. Contraindications against venous puncture 12. Other condition that might pose a risk to the study subject in the opinion of the investigator 13. Exclusion criteria for subproject CSF sampling
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2023-11-09