Alzheimer DiseaseT1rhoNCT03846232
Detection of Cerebral Proteinopathy in Alzheimer's Disease Through Magnetic Resonance Imaging
An observational study of Alzheimer Disease, run by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 12 Feb 2019to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Alzheimer Disease
- Being tested
- No intervention
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Other: No intervention | |
| Cognitively unimpaired, control | Normal cognition as defined by the ALFA study cognitive workup Negative amyloid PET in the last 30 months Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start12 Feb 2019
- Primary completion30 Nov 2020
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinic of Barcelona
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03846232
- Sponsor's protocol ID
- T1rho/BBRC2017
- Acronym
- T1rho
- Status last verified
- Nov 2022
- First submitted
- 18 Feb 2019
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T1rho: Detection of Cerebral Proteinopathy in Alzheimer's Disease Through Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT03846232
- Acronym / sponsor ID
- T1rho / T1rho/BBRC2017
- Conditions
- Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Barcelonabeta Brain Research Center, Pasqual Maragall FoundationUniversity, hospital or other
- Collaborators
- Hospital Clinic of Barcelona
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 19 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive impairment. Alzheimer's disease | – | Other: No interventionDiagnosed with AD as defined per the International Working Group IWG 2 criteria (fulfilling core clinical criteria plus positive core AD CSF biomarkers) |
| Cognitively unimpaired, preclinical Alzheimer's disease | – | Other: No interventionNormal cognition as defined by the ALFA study cognitive workup Positive amyloid PET in the last 30 months |
| Cognitively unimpaired, control | – | Other: No interventionNormal cognition as defined by the ALFA study cognitive workup Negative amyloid PET in the last 30 months |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- Age ≥ 60 years
- Informed, written consent form
- To fully satisfy the criteria for one of the two following 2 groups:
- CONFIDENTIAL 17
- [18F]-Flutemetamol PET scan performed in the context of the PET FLUTEMETAMOL-FDG/BBRC2015 study in the last 24 months.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Cognitive impairment. Alzheimer's disease, Cognitively unimpaired, control, Cognitively unimpaired, preclinical Alzheimer's disease |
Primary outcome
Detection of abnormal cerebral protein levels
Time frame: at inclusion
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by Barcelonabeta Brain Research Center, Pasqual Maragall Foundation at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of abnormal cerebral protein levels (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.