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

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

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08005
    • BarcelonaBeta Brain Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	Other: 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	Other: 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	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Detection of abnormal cerebral protein levels	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).	at inclusion

Collaborators and Investigators

• Sponsor: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
• Collaborators: Hospital Clinic of Barcelona

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2019
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: February 18, 2019
• First Submitted That Met QC Criteria: February 18, 2019
• First Posted (Actual): February 19, 2019

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: T1rho/BBRC2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No