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

Barcelonabeta Brain Research Center, Pasqual Maragall Foundation

Status: Completed

Conditions: Alzheimer Disease

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT03846232

T1rho/BBRC2017

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 60+ years old

Volunteers: 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.

Trial design

60 participants in 3 patient groups

Cognitive impairment. Alzheimer's disease

Description:

Diagnosed with AD as defined per the International Working Group IWG 2 criteria (fulfilling core clinical criteria plus positive core AD CSF biomarkers)

Treatment:

Other: No intervention

Cognitively unimpaired, preclinical Alzheimer's disease

Description:

Normal cognition as defined by the ALFA study cognitive workup Positive amyloid PET in the last 30 months

Treatment:

Other: No intervention

Cognitively unimpaired, control

Description:

Normal cognition as defined by the ALFA study cognitive workup Negative amyloid PET in the last 30 months

Treatment:

Other: No intervention