Primary Progressive AphasiaPPANCT04726527
Clinical Evaluation of Florbetapir in Primary Progressive Aphasia
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 years and older
- Conditions the study is for
- Primary Progressive Aphasia, Alzheimer Disease, Dementia
- What is being tested?
- Florbetapir F 18 and Positron Emission Tomography
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2012to 28 Feb 2017
- 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: 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.
Who may be able to join
- Subjects who, in the opinion of the investigator, can tolerate the PET scan procedures
Who cannot join
- Clinically significant cardiovascular disease
- clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances
- Pregnant
- Breastfeeding
- Women of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception.
- History of relevant severe drug allergy or hypersensitivity
- Patients who have received an investigational medication under an FDA Investigational New Drug (IND) protocol within the last 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Healthy Aging & Alzheimer's Research Care Center - University of Chicago
Chicago, Illinois, 60637
About this study
Official title: Clinical Evaluation of Florbetapir F 18 (18F-AV-45) / Determinants of Neurodegenerative Decline 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 is being done to examine the usefulness of Positron Emission Tomography (PET) imaging with florbetapir F 18 as a biomarker in the identification of amyloid-ß peptide (Aß) in the brain. Amyloid-ß peptide (Aß) accumulates in the brains of patients with Alzheimer's disease. Florbetapir F 18 sticks to the amyloid plaques in the brain and emits a low level of gamma rays which can be detected by a PET camera. The development of biomarker and imaging studies that track the development of PPA and reflect the change in people's bodies may help other people who have a similar medical problem in the future.
- Conditions
- Primary Progressive Aphasia, Alzheimer Disease, Dementia
- Being tested
- Florbetapir F 18, Positron Emission Tomography
- 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.
Florbetapir F 18Drug
Also called trade name Amyvid
A single injection of 10 mCi (370 MBq) florbetapir F 18 will be administered by intravenous bolus injection.
Positron Emission TomographyDevice
Also called PET
PET Scan for brain imaging
| Study group | Role | What they receive |
|---|---|---|
| Florbetapir F 18 Recipients | Participants in this arm of the study will receive a 10 mCi (370 MBq) bolus injection of florbetapir F 18 and then be scanned in a PET scanner for brain imaging. Receives: Drug: Florbetapir F 18; Device: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detecting amyloid burden in subjects with neurodegenerative diseases
The study will provide standardized conditions for florbetapir F 18 use, amyloid binding as measured by PET imaging, and long-term outcome in cognitively normal volunteers, patients with Alzheimer's Disease, patients with Mild Cognitive Impairment, and patients with other neurodegenerative diseases. It will also facilitate evaluation of subject's amyloid burden in companion studies such as longitudinal studies of aging, studies of progressive cognitive impairment, and studies of imaging and blood/cerebrospinal fluid biomarkers of neurodegenerative disease.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start15 Mar 2012
- Primary completion2 Sep 2015
- Study completion28 Feb 2017
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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emily Rogalski, Ph.D, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726527
- Sponsor's protocol ID
- IRB23-1391
- Acronym
- PPA
- Status last verified
- Oct 2024
- First submitted
- 22 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
- Clinical Evaluation of Florbetapir F 18 (18F-AV-45) / Determinants of Neurodegenerative Decline in Primary Progressive Aphasia
- ClinicalTrials.gov ID
- NCT04726527
- Acronym / sponsor ID
- PPA / IRB23-1391
- Conditions
- Primary Progressive Aphasia, Alzheimer Disease, Dementia
- Keywords
- Alzheimer's Disease, Dementia, Primary Progressive Aphasia, Neurocognitive Disorders, Speech Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 15 Mar 2012 (actual)
- Primary completion
- 2 Sep 2015 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 27 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 is being done to examine the usefulness of Positron Emission Tomography (PET) imaging with florbetapir F 18 as a biomarker in the identification of amyloid-ß peptide (Aß) in the brain. Amyloid-ß peptide (Aß) accumulates in the brains of patients with Alzheimer's disease. Florbetapir F 18 sticks to the amyloid plaques in the brain and emits a low level of gamma rays which can be detected by a PET camera. The development of biomarker and imaging studies that track the development of PPA and reflect the change in people's bodies may help other people who have a similar medical problem in the future.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Florbetapir F 18 Recipients | – | Drug: Florbetapir F 18, Device: Positron Emission TomographyParticipants in this arm of the study will receive a 10 mCi (370 MBq) bolus injection of florbetapir F 18 and then be scanned in a PET scanner for brain imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- 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.
Key inclusion criteria (1 listed)
- Subjects who, in the opinion of the investigator, can tolerate the PET scan procedures
Key exclusion criteria (7 listed)
- Clinically significant cardiovascular disease
- clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances
- Pregnant
- Breastfeeding
- Women of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception.
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 |
|---|---|---|
| Florbetapir F 18Also: trade name AmyvidA single injection of 10 mCi (370 MBq) florbetapir F 18 will be administered by intravenous bolus injection. | Drug | Florbetapir F 18 Recipients |
| Positron Emission TomographyAlso: PETPET Scan for brain imaging | Device | Florbetapir F 18 Recipients |
Primary outcome
Detecting amyloid burden in subjects with neurodegenerative diseases
Time frame: 4 years
The study will provide standardized conditions for florbetapir F 18 use, amyloid binding as measured by PET imaging, and long-term outcome in cognitively normal volunteers, patients with Alzheimer's Disease, patients with Mild Cognitive Impairment, and patients with other neurodegenerative diseases. It will also facilitate evaluation of subject's amyloid burden in companion studies such as longitudinal studies of aging, studies of progressive cognitive impairment, and studies of imaging and blood/cerebrospinal fluid biomarkers of neurodegenerative disease.
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 7 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?
Detecting amyloid burden in subjects with neurodegenerative diseases (time frame: 4 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.