EUCTR2015-005604-29-NL
Active, not recruiting
Phase 1
Tau-imaging in tauopathies; Alzheimer’s disease and non-AD dementias - TITA
VU University Medical Center0 sitesJanuary 20, 2016
ConditionsDementia inducing Alzheimer's disease, Frontotemporal dementia (FTD) and Lewy Body Dementia (DLB)MedDRA version: 20.0Level: PTClassification code 10012271Term: Dementia Alzheimer's typeSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: LLTClassification code 10057095Term: Diffuse Lewy body diseaseSystem Organ Class: 100000072901MedDRA version: 20.0Level: PTClassification code 10068968Term: Frontotemporal dementiaSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: LLTClassification code 10012283Term: Dementia due to other general medical conditionsSystem Organ Class: 100000014717Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Dementia inducing Alzheimer's disease, Frontotemporal dementia (FTD) and Lewy Body Dementia (DLB)
- Sponsor
- VU University Medical Center
- Status
- Active, not recruiting
- Last Updated
- 8 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 50 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 criteria. This will be determined using PET and/or CSF evidence of Aß deposition.
- •For MCI due to AD” patients;
- •\-Patients must meet clinical criteria for MCI, and;
- •present with positive Aß biomarkers on PET and/or CSF.For patients with a dementia syndrome likely induced by tauopathy;
- •For DLB patients;
Exclusion Criteria
- •No MRI available or possible
- •Abnormalities on MRI which may interfere with PET image assessment:
- •Is or may become pregnant in the 90 days 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 current clinically significant cardiovascular disease or clinically significant abnormalities on screening ECG (e.g. QTc \> 450 msec)
- •Has a history of moderate or severe traumatic brain injury (TBI).
Outcomes
Primary Outcomes
Not specified
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