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MCINCT06402370

Amyloid PET in Patients With Mild Cognitive Impairment and Early Dementia

An observational study of MCI, run by University Hospital, Ghent at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The National Institute on Aging together with the Alzheimer's Association (NIA-AA) recently proposed the ATN classification which is based upon the pathological processes present in Alzheimer's disease (amyloid, tau and neurodegeneration). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
MCI
What is being tested?
PET scan
How many people
50 participants
Where
1 siteBelgium
Study dates
8 May 2024to May 2026
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 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Patients with early Alzheimer and mild cognitive impairment

Who may be able to join

  • Patients with mild cognitive impairment or early stage dementia who have a MRI and [18F]FDG PET/CT scan as part of routine clinical work-up

Who cannot join

  • Patient is not able to understand the study Patient is not able to lie still in the scanner for at least 30 minutes Pregnancy or breastfeeding

Trial locations and contacts

1 site in 1 country.

Van Weehaeghe Donatienne contact

+32 9 332 30 27

donatienne.vanweehaeghe@uzgent.be

Belgium1 site, 1 recruiting
  • Van Weehaeghe D

    Ghent, 9000

    Van Weehaeghe Donatienne, +32 9 332 30 27, donatienne.vanweehaeghe@uzgent.be

    Recruiting

Other trials in Belgium

About this study

The National Institute on Aging together with the Alzheimer's Association (NIA-AA) recently proposed the ATN classification which is based upon the pathological processes present in Alzheimer's disease (amyloid, tau and neurodegeneration). The amyloid and tau status can be defined using cerebrospinal fluid analysis but also non-invasively using an amyloid or tau PET scan. The N status can be defined using an [18F]-FDG PET scan which is in Belgium part of standard of care. Recently, it has been demonstrated, using different amyloid PET tracers, that early-frame amyloid scans can be a surrogate for [18F]-FDG PET scan.

Read the detailed description

With the general aging of the population, neurodegenerative diseases such as Alzheimer have an increasing prevalence. Recently, anti-β-amyloid-antibodies such as aducanumab and donanemab are under development. These treatments urge for techniques allowing early diagnosis and treatment monitoring during disease. [18F]FDG PET allows the visualization of metabolic disturbances and aid in the early diagnosis of Alzheimer, Amyloid PET is able to detect the amyloid plaques which can be present years before symptom onset. A recent meta-analysis demonstrated that amyloid PET has a high sensitivity (0.91) and specificity (0.81) in the differential diagnosis between Alzheimer and controls, however very poor specificity (0.41) was observed when differentiating between Alzheimer and patients with mild cognitive impairment.

The National Institute on Aging together with the Alzheimer's Association (NIA-AA) recently proposed the ATN classification which is based upon the pathological processes present in Alzheimer's disease (amyloid, tau and neurodegeneration). The amyloid and tau status can be obtained using cerebrospinal fluid analysis but also non-invasively using an amyloid or tau PET scan. The N status can be obtained using an [18F]FDG PET scan which is in Belgium part of standard of care. Both the [18F]FDG PET scan and the amyloid scans using [18F]Vizamyl are also proposed in the diagnostic algorithm for early and differential diagnoses of dementia .

Perfusion scans using [15O]H2O have shown a good correlation with [18F]FDG PET, illustrating the potential of perfusion as a proxy for neuronal dysfunction. Previously, it has been demonstrated that early amyloid scans represent perfusion and can therefore be used as a proxy for neuronal activity.

Next generation PET/CT scanners, such as the Omni Legend have a very high sensitivity which may enable ultra-short PET scans, which is important is this vulnerable patient group, or dynamic scans with a high effective time resolution due to the possibility to acquire short time frames with reasonable noise characteristics. Moreover, the ultrashort scan may limit the movement artefacts frequently encountered in this study population.

The investigators hypothesize that a one minute scan 5 minutes postinjection is sufficient to determine the N-status of a patients and that a one minute scan 90-110 minutes postinjection can determine the A-status.

Conditions
MCI
Being tested
PET scan

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PET scanDiagnostic test

    [18F]Vizamyl

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. N-status

    N-status can be determined using ultrashort early frame amyloid scans of 1 minute

    Measured: 2 years

  2. A-status

    A-status can be determined with a one minute scan 60-90 minutes after injection

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2024
  2. Study start8 May 2024
  3. Primary completionMay 2026 (estimated)
  4. Study completionMay 2026 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06402370
Sponsor's protocol ID
ONZ-2023-0444
Status last verified
May 2024
First submitted
2 May 2024
Last updated
20 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of MCI, run by University Hospital, Ghent at 1 site in Belgium.

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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 May 2024. 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 Belgium. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Van Weehaeghe Donatienne (+32 9 332 30 27, donatienne.vanweehaeghe@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

N-status (time frame: 2 years). The study lists 2 primary outcomes in all. 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 20 May 2024.

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