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

Alzheimer Disease Clinical Trial

— T1rho  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03846232
• Other study ID #: T1rho/BBRC2017
• Status: Completed
• Start date: February 12, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2022
• Source: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2022
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Spain	Barcelonabeta Brain Research Center	Barcelona

Sponsors (2)

Lead Sponsor	Collaborator
Barcelonabeta Brain Research Center, Pasqual Maragall Foundation	Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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