Status:
COMPLETED
Detection of Cerebral Proteinopathy in Alzheimer's Disease Through Magnetic Resonance Imaging
Lead Sponsor:
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Collaborating Sponsors:
Hospital Clinic of Barcelona
Conditions:
Alzheimer Disease
Eligibility:
All Genders
60+ years
Brief Summary
The main goal of the T1rho/BBRC2017 study is to assess the capability of the MRI sequences T1rho + multicomponent T2 relaxation analysis of detecting abnormal cerebral protein deposition in AD patient...
Eligibility Criteria
Inclusion
- Age ≥ 60 years
- Informed, written consent form
- To fully satisfy the criteria for one of the two following 2 groups:
- for the AD group:
- Diagnosed with AD as defined per the International Working Group IWG 2 criteria (fulfilling core clinical criteria plus positive core AD CSF biomarkers): Light to mild AD defined by Mini-Mental State Examination (MMSE) score between 15 and 27 (included).
- Documented positive visual read (as per EMA-approved procedures for each respective tracer) of an amyloid PET scan, which in the opinion of the principal investigator is consistent with a diagnosis of AD in the last 24 months.
- Lumbar puncture with core AD CSF biomarkers available in the last 24 months.
- For the cognitively health group:
- Normal cognition as defined by the ALFA study cognitive workup (Molinuevo et al. 2016).
- CONFIDENTIAL 17
- \[18F\]-Flutemetamol PET scan performed in the context of the PET FLUTEMETAMOL-FDG/BBRC2015 study in the last 24 months.
- Lumbar puncture with core AD CSF biomarkers preferably available in the last 24 months.
Exclusion
- Past or present history of major brain disorders other than MCI or AD.
- Contraindication to MRI scanning or conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).
- Participation in a clinical trial for a disease modifying drug for AD.
- Hypoperfusion pattern not consistent with AD diagnosis, as assessed by ASL.
Key Trial Info
Start Date :
February 12 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03846232
Start Date
February 12 2019
End Date
December 31 2022
Last Update
March 31 2023
Active Locations (1)
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1
Barcelonabeta Brain Research Center
Barcelona, Spain, 08005