Detection of Cerebral Proteinopathy in Alzheimer's Disease Through Magnetic Resonance Imaging
NCT ID: NCT03846232
Last Updated: 2023-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2019-02-12
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Cognitive impairment. Alzheimer's disease
Diagnosed with AD as defined per the International Working Group IWG 2 criteria (fulfilling core clinical criteria plus positive core AD CSF biomarkers)
No intervention
No intervention
Cognitively unimpaired, preclinical Alzheimer's disease
Normal cognition as defined by the ALFA study cognitive workup Positive amyloid PET in the last 30 months
No intervention
No intervention
Cognitively unimpaired, control
Normal cognition as defined by the ALFA study cognitive workup Negative amyloid PET in the last 30 months
No intervention
No intervention
Interventions
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No intervention
No intervention
Eligibility Criteria
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Inclusion Criteria
* Informed, written consent form
* To fully satisfy the criteria for one of the two following 2 groups:
1. 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.
2. 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 Criteria
* 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.
60 Years
ALL
Yes
Sponsors
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Hospital Clinic of Barcelona
OTHER
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
OTHER
Responsible Party
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Locations
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Barcelonabeta Brain Research Center
Barcelona, , Spain
Countries
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Other Identifiers
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T1rho/BBRC2017
Identifier Type: -
Identifier Source: org_study_id
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