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

Study Overview
=================
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.

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

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 60 years Informed, written consent form To fully satisfy the criteria for one of the two following 2 groups: 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. 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.

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cognitive impairment. Alzheimer's disease<br>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<br>* No intervention<br>|
| Cognitively unimpaired, preclinical Alzheimer's disease<br>Normal cognition as defined by the ALFA study cognitive workup Positive amyloid PET in the last 30 months | Other: No intervention<br>* No intervention<br>|
| Cognitively unimpaired, control<br>Normal cognition as defined by the ALFA study cognitive workup Negative amyloid PET in the last 30 months | Other: No intervention<br>* No intervention<br>|

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 |