NL-OMON50757
Completed
Phase 2
Tau Imaging in Tauopathies; Alzheimer's disease and Non-AD dementias - TITA
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- dementia
- Sponsor
- Vrije Universiteit Medisch Centrum
- Enrollment
- 200
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •\- 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;
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
Not specified
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