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Detection of Cerebral Proteinopathy in Alzheimer's Disease Through Magnetic Resonance Imaging

T1rho: Detection of Cerebral Proteinopathy in Alzheimer's Disease Through Magnetic Resonance Imaging

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03846232
Acronym
T1rho
Enrollment
60
Registered
2019-02-19
Start date
2019-02-12
Completion date
2022-12-31
Last updated
2023-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

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 patients in comparison with an age-matched cognitively healthy control group. Both the AD and control groups will had previously undergone amyloid PET imaging to confirm/discard cerebral proteinopathy in the context of other research studies.

Interventions

OTHERNo intervention

No intervention

Sponsors

Hospital Clinic of Barcelona
CollaboratorOTHER
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Age ≥ 60 years * 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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Detection of abnormal cerebral protein levelsat inclusionDiscriminant capacity to detect abnormal cerebral protein levels in 3 age-matched groups: cognitively normal subjects without (CN) and with abnormal biomarker levels (PreAD), and Alzheimer Disease patients (AD).

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026