Tau Imaging in Tauopathies; Alzheimer's disease and Non-AD dementias
- Conditions
- dementiaTauopathy1001462310012272
- Registration Number
- NL-OMON50757
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
In order to be eligible to participate in this study, a subject must meet all
of the following criteria: , - At least 35 years of age
- Subjects must, in the opinion of the principal investigator/attending
neurologist, be able to tolerate the [18F]AV1451 PET scan procedures and be
competent to make a well informed decision to participate in this study..,
Additional inclusion criteria per diagnostic group:, For probable AD dementia
patients;
- A diagnosis of probable AD with at least intermediate likelihood according to
recently proposed NIA-AA criteria27. This will be determined using PET and/or
CSF evidence of A* deposition., For *MCI due to AD* patients;
- Patients must meet clinical criteria for MCI25, and;
- present with positive A* biomarkers on PET and/or CSF., For DLB patients;
- At least 50 years of age
- Patients must be included in the DEvELOP (protocol number 15/548)
- Subjects must, in the opinion of the principal investigator/attending
neurologist, be able to tolerate the [18F] FDG PET scan procedures, For
controls;
- No objective evidence of cognitive impairment as assessed by a
multidisciplinary specialist team;
- normal MRI;
No MRI available or possible
Abnormalities on MRI which may interfere with PET image assessment:
Is or may become pregnant in the first 24h after the PET scan
Relevant history of drug allergy or hypersensitivity
Has ever recieved a tau and/or amyloid-beta targetting agent
Has been injected with a previously administered radiopharmaceutical within 6
terminal half-lives OR the total yearly radiation exposure exceeds 10 mSv;
Has a history of moderate or severe traumatic brain injury (TBI).
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>(Change in) the amount and distribution of specific [18F]AV1451 binding in DLB<br /><br>and AD</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Neuropsychological performance (over time);<br /><br>- DLB specific questionnaires<br /><br>- Gray matter volumes on MRI (over time);<br /><br>- CSF protein levels (over time);<br /><br>- Amyloid-beta PET tracer binding (when available).<br /><br>- FDG tracer binding<br /><br>- EEG measurements</p><br>