Alzheimer's DiseasePhase 1NCT02336360
Augmenting Flortaucipir Dosimetry Estimates
A Phase 1 study testing Flortaucipir F18 in people with Alzheimer's Disease, run by Avid Radiopharmaceuticals at 1 site in United States.
Trial summary
This study will obtain data from urine in subjects administered flortaucipir in an Avid-sponsored study to augment the calculation of radiation dosimetry estimates. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Flortaucipir F18
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Jun 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subjects who passed screening in an Avid-sponsored study in which flortaucipir will be administered
Who cannot join
- Subjects who have withdrawn informed consent
- Investigator or sponsor believes it is in the best interest of the subject to be removed from the trials
Trial locations and contacts
1 site in 1 country.
United States1 site
Molecular NeuroImaging
New Haven, Connecticut, 06510
About this study
Official title: A Multicenter Study to Obtain Data to Assist in Radiation Dosimetry Calculations From Subjects Enrolled in Human Studies Employing 18F-AV-1451
This study will obtain data from urine in subjects administered flortaucipir in an Avid-sponsored study to augment the calculation of radiation dosimetry estimates.
- Conditions
- Alzheimer's Disease
- Being tested
- Flortaucipir F18
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flortaucipir F18Drug
Also called 18F-AV-1451, [F-18]T807, LY3191748, Tauvid
No flortaucipir administered in this study. Subjects received flortaucipir in an Avid-sponsored study.
| Study group | Role | What they receive |
|---|---|---|
| Urine Analysis | Experimental | Urine will be collected from subjects administered flortaucipir in an Avid-sponsored study to determine the amount of radioactivity excreted in urine. Receives: Drug: Flortaucipir F18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine Analysis - Total Integrated Radioactivity Excreted in Urine
Total integrated radioactivity excreted in urine over time will be determined to augment previous radiation dosimetry calculations.
Measured: 0-360 minutes post injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer's 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avid Radiopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02336360
- Sponsor's protocol ID
- 18F-AV-1451-A15
- Status last verified
- Jul 2020
- First submitted
- 8 Jan 2015
- Last updated
- 11 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study to Obtain Data to Assist in Radiation Dosimetry Calculations From Subjects Enrolled in Human Studies Employing 18F-AV-1451
- ClinicalTrials.gov ID
- NCT02336360
- Acronym / sponsor ID
- 18F-AV-1451-A15
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Avid RadiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 13 Jan 2015 (estimated)
- Results
- Posted 11 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will obtain data from urine in subjects administered flortaucipir in an Avid-sponsored study to augment the calculation of radiation dosimetry estimates.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Urine Analysis | Experimental | Drug: Flortaucipir F18Urine will be collected from subjects administered flortaucipir in an Avid-sponsored study to determine the amount of radioactivity excreted in urine. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects who passed screening in an Avid-sponsored study in which flortaucipir will be administered
Key exclusion criteria (2 listed)
- Subjects who have withdrawn informed consent
- Investigator or sponsor believes it is in the best interest of the subject to be removed from the trials
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 |
|---|---|---|
| Flortaucipir F18Also: 18F-AV-1451, [F-18]T807, LY3191748, TauvidNo flortaucipir administered in this study. Subjects received flortaucipir in an Avid-sponsored study. | Drug | Urine Analysis |
Primary outcome
Urine Analysis - Total Integrated Radioactivity Excreted in Urine
Time frame: 0-360 minutes post injection
Total integrated radioactivity excreted in urine over time will be determined to augment previous radiation dosimetry calculations.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Aging
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?
A Phase 1 study testing Flortaucipir F18 in people with Alzheimer's Disease, run by Avid Radiopharmaceuticals 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 2 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 11 Aug 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Urine Analysis - Total Integrated Radioactivity Excreted in Urine (time frame: 0-360 minutes post injection). 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 11 Aug 2020.