NCT03846232

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 12, 2019

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

March 31, 2023

Status Verified

November 1, 2022

Enrollment Period

1.8 years

First QC Date

February 18, 2019

Last Update Submit

March 30, 2023

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

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

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

Cognitively unimpaired, control

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

Other: No intervention

Interventions

No interventionOTHER

No intervention

Cognitive impairment. Alzheimer's diseaseCognitively unimpaired, controlCognitively unimpaired, preclinical Alzheimer's disease

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barcelonabeta Brain Research Center

Barcelona, 08005, Spain

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2019

First Posted

February 19, 2019

Study Start

February 12, 2019

Primary Completion

November 30, 2020

Study Completion

December 31, 2022

Last Updated

March 31, 2023

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)