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

NCT03846232 — Completed, 60 participants, Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

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

Registry	NCT03846232, acronym T1rho
Status	Completed
Study type	Observational
Enrollment	60 (Actual)
Sponsor	Barcelonabeta Brain Research Center, Pasqual Maragall Foundation (Other); collaborators: Hospital Clinic of Barcelona
Conditions	Alzheimer Disease
Interventions	No intervention (Other)
Dates	start 2019-02-12, primary completion 2020-11-30, completion 2022-12-31, first posted 2019-02-19, last updated 2023-03-31
Locations	1 site in Spain

-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.

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+Arms and interventions

Arm	Interventions	Description
Cognitive impairment. Alzheimer's disease	Other: No intervention	Diagnosed with AD as defined per the International Working Group IWG 2 criteria (fulfilling core clinical criteria plus positive core AD CSF biomarkers)
Cognitively unimpaired, preclinical Alzheimer's disease	Other: No intervention	Normal cognition as defined by the ALFA study cognitive workup Positive amyloid PET in the last 30 months
Cognitively unimpaired, control	Other: No intervention	Normal cognition as defined by the ALFA study cognitive workup Negative amyloid PET in the last 30 months

No intervention (Other): No intervention

+Outcome measures

Primary outcomes

Detection of abnormal cerebral protein levels [at inclusion]: Discriminant 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).

+Eligibility

Sex: All, ages: 60 Years to any, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Barcelonabeta Brain Research Center	Barcelona	Spain