Primary Progressive AphasiaNCT04720001
Florbetaben PET Imaging in PPA
An observational study of Primary Progressive Aphasia and Alzheimer Disease, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this research is to better understand how dementia affects activity in different parts of the brain. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Primary Progressive Aphasia, Alzheimer Disease
- What is being tested?
- Florbetaben F18 and PET
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2018to 26 Feb 2021
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from other research projects at Northwestern's Mesulam Center. Some of these projects recruit participants from the local Chicagoland area and others recruit participants from across the United States. As Primary Progressive Aphasia is an uncommon syndrome, participant recruitment is not focused on a specific demographic area.
Who may be able to join
- Participants must have a diagnosis of PPA or a related dementia syndrome
Who cannot join
- Pregnant
- Breastfeeding
- Receiving radiation clinically
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago - American School Building
Chicago, Illinois, 60637
About this study
Official title: Florbetaben PET Imaging in Primary Progressive Aphasia
The purpose of this research is to better understand how dementia affects activity in different parts of the brain.
Read the detailed description
This study will examine Positron Emission Tomography (PET) imaging with Florbetaben F18. Florbetaben F18 is a radioactive tracer that binds to particles in your brain. This process displays activity in the brain. Florbetaben F18 is a PET amyloid imaging agent approved by the United States Food and Drug Administration (FDA) to estimate the amount of beta-amyloid plaque in adult patients who are being evaluated for Alzheimer's disease and other causes of cognitive decline. The purpose of this research is to better understand how dementia affects activity in different parts of the brain. Currently, the scientific community is limited by how well it can see inside the brain. The use of a PET scan better helps us understand what the brain looks like in a diseased state. Participation in the study will help to understand what brain activity looks like, especially around language regions.
- Conditions
- Primary Progressive Aphasia, Alzheimer Disease
- Being tested
- Florbetaben F18, PET
- Keywords
- Alzheimer's Disease, Dementia, Primary Progressive Aphasia, Neurocognitive Disorders, Speech Disorders
- Medical subject headings
- Aphasia, Primary Progressive, Alzheimer Disease, Dementia, Neurocognitive Disorders, Speech Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Florbetaben F18Drug
Also called trade name NeuraCeq
A single injection of 8.1mCi of florbetaben F18 will be administered by intravenous bolus injection
PETDevice
PET Scan for brain imaging
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Florbetaben F18 recipients | Participants in this arm of the study will receive 8.1mCi of florbetaben F18 and then be scanned in a PET scanner for brain imaging. Receives: Drug: Florbetaben F18; Device: PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amyloid plaque levels in PPA participants
Amyloid plaque aggregation as measured by florbetaben F18 standard uptake value ratio cerebral and cerebellar regions of interest.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start23 Aug 2018
- Primary completion21 Jan 2021
- Study completion26 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Progressive AphasiaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University
- Responsible party
- Sponsor
- Investigators
- Emily Rogalski, Ph.D, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720001
- Sponsor's protocol ID
- IRB23-1360
- Status last verified
- Feb 2022
- First submitted
- 19 Jan 2021
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Florbetaben PET Imaging in Primary Progressive Aphasia
- ClinicalTrials.gov ID
- NCT04720001
- Acronym / sponsor ID
- IRB23-1360
- Conditions
- Primary Progressive Aphasia, Alzheimer Disease
- Keywords
- Alzheimer's Disease, Dementia, Primary Progressive Aphasia, Neurocognitive Disorders, Speech Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Northwestern University
- Study start
- 23 Aug 2018 (actual)
- Primary completion
- 21 Jan 2021 (actual)
- Study completion
- 26 Feb 2021 (actual)
- First posted
- 22 Jan 2021 (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 purpose of this research is to better understand how dementia affects activity in different parts of the brain.
Detailed description
This study will examine Positron Emission Tomography (PET) imaging with Florbetaben F18. Florbetaben F18 is a radioactive tracer that binds to particles in your brain. This process displays activity in the brain. Florbetaben F18 is a PET amyloid imaging agent approved by the United States Food and Drug Administration (FDA) to estimate the amount of beta-amyloid plaque in adult patients who are being evaluated for Alzheimer's disease and other causes of cognitive decline. The purpose of this research is to better understand how dementia affects activity in different parts of the brain. Currently, the scientific community is limited by how well it can see inside the brain. The use of a PET scan better helps us understand what the brain looks like in a diseased state. Participation in the study will help to understand what brain activity looks like, especially around language regions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Florbetaben F18 recipients | – | Drug: Florbetaben F18, Device: PETParticipants in this arm of the study will receive 8.1mCi of florbetaben F18 and then be scanned in a PET scanner for brain imaging. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from other research projects at Northwestern's Mesulam Center. Some of these projects recruit participants from the local Chicagoland area and others recruit participants from across the United States. As Primary Progressive Aphasia is an uncommon syndrome, participant recruitment is not focused on a specific demographic area.
Key inclusion criteria (1 listed)
- Participants must have a diagnosis of PPA or a related dementia syndrome
Key exclusion criteria (3 listed)
- Pregnant
- Breastfeeding
- Receiving radiation clinically
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 |
|---|---|---|
| Florbetaben F18Also: trade name NeuraCeqA single injection of 8.1mCi of florbetaben F18 will be administered by intravenous bolus injection | Drug | Experimental: Florbetaben F18 recipients |
| PETPET Scan for brain imaging | Device | Experimental: Florbetaben F18 recipients |
Primary outcome
Amyloid plaque levels in PPA participants
Time frame: 2 Years
Amyloid plaque aggregation as measured by florbetaben F18 standard uptake value ratio cerebral and cerebellar regions of interest.
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 16 Oct 2024.
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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.
Emily Rogalski, Ph.D principal investigator
University of Chicago
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 Primary Progressive Aphasia and Alzheimer Disease, run by University of Chicago at 1 site in United States.
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 3 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 16 Oct 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 United States. 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?
Amyloid plaque levels in PPA participants (time frame: 2 Years). 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 16 Oct 2024; AzTrials last refreshed its copy on 30 Oct 2026.