Clinical trial NCT03846232: Detection of Cerebral Proteinopathy in Alzheimer's Disease Through Magnetic Resonance Imaging
Official title: T1rho: Detection of Cerebral Proteinopathy in Alzheimer's Disease Through Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Lead sponsor: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Sponsor class: OTHER
Collaborators: name: Hospital Clinic of Barcelona
First posted: 2019-02-19
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participating subjects are (1) patients with AD with typical presentation for which an amyloid PET is already available or (2) age-matched cognitively healthy adults that, similarly, have available amyloid PET imaging information.

Specifically, a subsample of 40 cognitively healthy adult participants from the ALFA study \[25\] (http://clinicaltrials.gov/ct2/show/NCT01835717; Estudi 45-65 FPM/2012) will be selected to undergo the present study on the basis of their cerebral amyloidosis as assessed by PET in the context of the PET FLUTEMETAMOL-FDG/BBRC2015 study (20 negative and 20 positive). AD patients (n=20) will be recruited from collaborating institutions.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Detection of abnormal cerebral protein levels
timeFrame: at inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Barcelonabeta Brain Research Center
Study officials:
References: