Alzheimer's Disease, Early OnsetNCT02289118
Tau Imaging in Young Onset Dementia
An observational study of Alzheimer's Disease, Early Onset and Logopenic Progressive Aphasia, run by University of Pennsylvania at 1 site in United States.
Trial summary
The central goal of this study is to determine and compare the similarities and differences in regional brain uptake of [18F]T807 in patients with typical Alzheimer's Disease (AD), Posterior Cortical Atrophy (PCA), and Logopenic Variant of Primary Progressive Aphasia (lvPPA). Read more about this study
- Who is it for?
- Ages 45 to 70 years
- Conditions the study is for
- Alzheimer's Disease, Early Onset, Logopenic Progressive Aphasia, Posterior Cortical Atrophy (PCA)
- What is being tested?
- [18F]-T807 imaging tracer
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to 31 Jan 2019
- 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 45 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with early onset AD (symptoms preceding age 65)
Who may be able to join
- Participants will be 45 - 70 years of age
- MMSE > 10 at screening visit.
- Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures. If the patient is unable to provide informed consent, the patient's legal representative may consent on behalf of the patient but the patient will be asked to confirm assent.
- Participants must be willing and able to comply with scheduled visits and imaging procedures.
- A brain MRI is required. If a brain MRI has been performed within 6 months of enrollment to this study and of adequate quality that scan may be used for the study analysis, subjects who do not have a brain MRI will undergo a brain MRI either as a part of this study
- Participants must identify a study partner who is willing to accompany the patient to study visits
Who cannot join
- Females who are pregnant or breast feeding at the time of screening scan will not be eligible for this study, urine or serum pregnancy test will be performed in women of child-bearing potential at the time of screening
- Inability to tolerate or contraindication to imaging procedures (PET/CT or MRI) in the opinion of an investigator or treating physician
- QTc > 450 msec on screening ECG.
- Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study (e.g. moderate to large stroke or history of moderate or severe traumatic brain injury (TBI)).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: [18F]-T807 PET/CT Imaging of Tau Pathology in Young Onset Focal Dementia
The central goal of this study is to determine and compare the similarities and differences in regional brain uptake of [18F]T807 in patients with typical Alzheimer's Disease (AD), Posterior Cortical Atrophy (PCA), and Logopenic Variant of Primary Progressive Aphasia (lvPPA). The investigators will correlate patterns of [18F]T807 binding with magnetic resonance imaging (MRI)-based regional volumetric and cortical thickness measures. If cerebral spinal fluid (CSF) samples are not available, patients may be asked to get an optional lumbar puncture (LP) for additional comparisons. The investigators will recruit 20 participants, 45-70 years old, with clinical evidence of young onset focal dementia.
- Conditions
- Alzheimer's Disease, Early Onset, Logopenic Progressive Aphasia, Posterior Cortical Atrophy (PCA)
- Being tested
- [18F]-T807 imaging tracer
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]-T807 imaging tracerDrug
Also called AV-1451
Tau Imaging tracer
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Imaging | [18F]T807 imaging tracer. Receives: Drug: [18F]-T807 imaging tracer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine and compare the similarities and differences in regional brain uptake of [18F]T807 by using standardized uptake value ratio (SUVr) in patients with typical AD, PCA and lvPPA
Measured: 2 years
Correlate patterns of [18F]T807 binding based on standardized uptake value ratio (SUVr) with MRI-based regional volumetric (mm3) and cortical thickness (mm) measures
Measured: 2 years
Secondary outcomes (2)
Correlate CSF markers of amyloid (Aβ1-42) and/or tau (total tau, phospho-tau) pathology (pg/mL) to uptake of [18F]T807 based on standardized uptake value ratio (SUVr).
Measured: 2 years
Correlate [18F]T807 binding based on standardized uptake value ratio (SUVr) with standard cognitive tests.
Neurocognitive test results
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 posted13 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2018
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's Disease, Early OnsetStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Wolk, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02289118
- Sponsor's protocol ID
- 820665
- Status last verified
- Mar 2020
- First submitted
- 5 Nov 2014
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [18F]-T807 PET/CT Imaging of Tau Pathology in Young Onset Focal Dementia
- ClinicalTrials.gov ID
- NCT02289118
- Acronym / sponsor ID
- 820665
- Conditions
- Alzheimer's Disease, Early Onset, Logopenic Progressive Aphasia, Posterior Cortical Atrophy (PCA)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 13 Nov 2014 (estimated)
- 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 central goal of this study is to determine and compare the similarities and differences in regional brain uptake of [18F]T807 in patients with typical Alzheimer's Disease (AD), Posterior Cortical Atrophy (PCA), and Logopenic Variant of Primary Progressive Aphasia (lvPPA). The investigators will correlate patterns of [18F]T807 binding with magnetic resonance imaging (MRI)-based regional volumetric and cortical thickness measures. If cerebral spinal fluid (CSF) samples are not available, patients may be asked to get an optional lumbar puncture (LP) for additional comparisons. The investigators will recruit 20 participants, 45-70 years old, with clinical evidence of young onset focal dementia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Imaging | – | Drug: [18F]-T807 imaging tracer[18F]T807 imaging tracer. |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with early onset AD (symptoms preceding age 65)
Key inclusion criteria (6 listed)
- Participants will be 45 - 70 years of age
- MMSE > 10 at screening visit.
- Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures. If the patient is unable to provide informed consent, the patient's legal representative may consent on behalf of the patient but the patient will be asked to confirm assent.
- Participants must be willing and able to comply with scheduled visits and imaging procedures.
- A brain MRI is required. If a brain MRI has been performed within 6 months of enrollment to this study and of adequate quality that scan may be used for the study analysis, subjects who do not have a brain MRI will undergo a brain MRI either as a part of this study
Key exclusion criteria (4 listed)
- Females who are pregnant or breast feeding at the time of screening scan will not be eligible for this study, urine or serum pregnancy test will be performed in women of child-bearing potential at the time of screening
- Inability to tolerate or contraindication to imaging procedures (PET/CT or MRI) in the opinion of an investigator or treating physician
- QTc > 450 msec on screening ECG.
- Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study (e.g. moderate to large stroke or history of moderate or severe traumatic brain injury (TBI)).
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 |
|---|---|---|
| [18F]-T807 imaging tracerAlso: AV-1451Tau Imaging tracer | Drug | Diagnostic Imaging |
Primary outcome
Determine and compare the similarities and differences in regional brain uptake of [18F]T807 by using standardized uptake value ratio (SUVr) in patients with typical AD, PCA and lvPPA
Time frame: 2 years
Correlate patterns of [18F]T807 binding based on standardized uptake value ratio (SUVr) with MRI-based regional volumetric (mm3) and cortical thickness (mm) measures
Time frame: 2 years
2 secondary outcomes
Correlate CSF markers of amyloid (Aβ1-42) and/or tau (total tau, phospho-tau) pathology (pg/mL) to uptake of [18F]T807 based on standardized uptake value ratio (SUVr).
Time frame: 2 years
Correlate [18F]T807 binding based on standardized uptake value ratio (SUVr) with standard cognitive tests.
Time frame: 2 years
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 25 Mar 2020.
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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.
David Wolk, MD principal investigator
University of Pennsylvania
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's Disease, Early Onset and Logopenic Progressive Aphasia, run by University of Pennsylvania 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 6 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 25 Mar 2020. 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?
Determine and compare the similarities and differences in regional brain uptake of [18F]T807 by using standardized uptake value ratio (SUVr) in patients with typical AD, PCA and lvPPA (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 25 Mar 2020.