Alzheimer's DiseasePhase 1NCT01992380
A Study of Flortaucipir PET in Healthy Volunteers and Cognitively Impaired Subjects
A Phase 1 study testing Flortaucipir F18 and Brain PET scan in people with Alzheimer's Disease, run by Avid Radiopharmaceuticals at 2 sites in United States.
Trial summary
This study will test if two flortaucipir PET scans up to 4 weeks apart in healthy volunteers, MCI and AD subjects provide the same results. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Flortaucipir F18 and Brain PET scan
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Nov 2013to 30 May 2014
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Volunteers
- Male or female subjects ≥ 50 years of age
- Mini-mental state examination (MMSE) ≥ 29
- MCI Subjects
- Male or female subjects ≥ 50 years of age
- MMSE ≥ 24
Show all 13Show fewer
- Have MCI consistent with National Institute on Aging-Alzheimer's Association (NIA-AA) working group's diagnostic guidelines for AD
- Have a study partner that can report on subject's activities of daily living
- Probable AD Subjects
- Male or female subjects ≥ 50 years of age
- MMSE > 10
- Meet clinical criteria for probable AD based on the NIA-AA working group's diagnostic guidelines for AD
- Have a study partner that can report on subject's activities of daily living
Who cannot join
- Current clinically significant psychiatric disease
- Evidence of structural brain abnormalities
- Evidence of dementing illness other than AD
- Current clinically significant cardiovascular disease or ECG abnormalities, or additional risk factors for Torsades de Pointes
- Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
- History of alcohol or substance abuse or dependence
Show all 9Show fewer
- Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception
- Have received or participated in a trial with investigational medications in the past 30 days
- have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Research Site
New Haven, Connecticut, 06510
Research Site
Newport Beach, California, 92663
About this study
Official title: Test-Retest Reproducibility of 18F-AV-1451 Injection for Brain Imaging of Tau in Healthy Volunteers and Cognitively Impaired Subjects.
This study will test if two flortaucipir PET scans up to 4 weeks apart in healthy volunteers, MCI and AD subjects provide the same results.
- Conditions
- Alzheimer's Disease
- Being tested
- Flortaucipir F18, Brain PET scan
- 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 [F18]T807, 18F-AV-1451, Tauvid
IV injection, 370 MBq (10 mCi), two doses up to four weeks apart
Brain PET scanProcedure or surgery
positron emission tomography (PET) scan of the brain at 80-100 and 110-130 minutes after injection
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteer Subjects | Experimental | Healthy males or females 50 years or older with no evidence of cognitive impairment Receives: Drug: Flortaucipir F18; Procedure: Brain PET scan |
| MCI subjects | Experimental | Subjects 50 years or older with mild cognitive impairment (MCI) Receives: Drug: Flortaucipir F18; Procedure: Brain PET scan |
| Probable AD Subjects | Experimental | Subjects 50 years or older with probable Alzheimer's Disease (AD) Receives: Drug: Flortaucipir F18; Procedure: Brain PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Test-Retest Reproducibility
Evaluate test-retest reproducibility of flortaucipir for brain imaging of tau in healthy volunteers and subjects with cognitive impairment. Standard uptake value ratios (SUVRs) for each scan, normalized to the cerebellar crus. A combination volume of interest (VOI) = weighted average of parietal, temporal, and occipital regions was used. The protocol pre-specified that test-retest endpoint was to be calculated for the combined group of healthy volunteers and cognitively impaired subjects
Measured: 80-100 minutes postdose
Test-Retest Reproducibility
Evaluate test-retest reproducibility of 18F-AV-1451 for brain imaging of tau in healthy volunteers and subjects with cognitive impairment. Standard uptake value ratios (SUVRs) for each scan, normalized to the cerebellar crus. A combination volume of interest (VOI) = weighted average of parietal, temporal, and occipital regions was used. The protocol pre-specified that test-retest endpoint was to be calculated for the combined group of healthy volunteers and cognitively impaired subjects
Measured: 110-130 minutes postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study start13 Nov 2013
- Primary completion30 May 2014
- Study completion30 May 2014
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Avid Radiopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study chair, Avid Radiopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01992380
- Sponsor's protocol ID
- 18F-AV-1451-A03
- Status last verified
- Aug 2020
- First submitted
- 8 Nov 2013
- Last updated
- 7 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Devous MD Sr, Joshi AD, Navitsky M, Southekal S, Pontecorvo MJ, Shen H, Lu M, Shankle WR, Seibyl JP, Marek K, Mintun MA. Test-Retest Reproducibility for the Tau PET Imaging Agent Flortaucipir F 18. J Nucl Med. 2018 Jun;59(6):937-943. doi: 10.2967/jnumed.117.200691. Epub 2017 Dec 28.
PubMed 29284675
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test-Retest Reproducibility of 18F-AV-1451 Injection for Brain Imaging of Tau in Healthy Volunteers and Cognitively Impaired Subjects.
- ClinicalTrials.gov ID
- NCT01992380
- Acronym / sponsor ID
- 18F-AV-1451-A03
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Avid RadiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2013 (actual)
- Primary completion
- 30 May 2014 (actual)
- Study completion
- 30 May 2014 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Posted 7 Sep 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 test if two flortaucipir PET scans up to 4 weeks apart in healthy volunteers, MCI and AD subjects provide the same results.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteer Subjects | Experimental | Drug: Flortaucipir F18, Procedure: Brain PET scanHealthy males or females 50 years or older with no evidence of cognitive impairment |
| MCI subjects | Experimental | Drug: Flortaucipir F18, Procedure: Brain PET scanSubjects 50 years or older with mild cognitive impairment (MCI) |
| Probable AD Subjects | Experimental | Drug: Flortaucipir F18, Procedure: Brain PET scanSubjects 50 years or older with probable Alzheimer's Disease (AD) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Healthy Volunteers
- MCI Subjects
- Probable AD Subjects
Key exclusion criteria (9 listed)
- Current clinically significant psychiatric disease
- Evidence of structural brain abnormalities
- Evidence of dementing illness other than AD
- Current clinically significant cardiovascular disease or ECG abnormalities, or additional risk factors for Torsades de Pointes
- Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer
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: [F18]T807, 18F-AV-1451, TauvidIV injection, 370 MBq (10 mCi), two doses up to four weeks apart | Drug | Healthy Volunteer Subjects, MCI subjects, Probable AD Subjects |
| Brain PET scanpositron emission tomography (PET) scan of the brain at 80-100 and 110-130 minutes after injection | Procedure or surgery | Healthy Volunteer Subjects, MCI subjects, Probable AD Subjects |
Primary outcome
Test-Retest Reproducibility
Time frame: 80-100 minutes postdose
Evaluate test-retest reproducibility of flortaucipir for brain imaging of tau in healthy volunteers and subjects with cognitive impairment. Standard uptake value ratios (SUVRs) for each scan, normalized to the cerebellar crus. A combination volume of interest (VOI) = weighted average of parietal, temporal, and occipital regions was used. The protocol pre-specified that test-retest endpoint was to be calculated for the combined group of healthy volunteers and cognitively impaired subjects
Test-Retest Reproducibility
Time frame: 110-130 minutes postdose
Evaluate test-retest reproducibility of 18F-AV-1451 for brain imaging of tau in healthy volunteers and subjects with cognitive impairment. Standard uptake value ratios (SUVRs) for each scan, normalized to the cerebellar crus. A combination volume of interest (VOI) = weighted average of parietal, temporal, and occipital regions was used. The protocol pre-specified that test-retest endpoint was to be calculated for the combined group of healthy volunteers and cognitively impaired subjects
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29284675Devous MD Sr, Joshi AD, Navitsky M, Southekal S, Pontecorvo MJ, Shen H, Lu M, Shankle WR, Seibyl JP, Marek K, Mintun MA. Test-Retest Reproducibility for the Tau PET Imaging Agent Flortaucipir F 18. J Nucl Med. 2018 Jun;59(6):937-943. doi: 10.2967/jnumed.117.200691. Epub 2017 Dec 28.
Related trials for Alzheimer's Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
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.
Chief Medical Officer study chair
Avid Radiopharmaceuticals
2 sites 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 and Brain PET scan in people with Alzheimer's Disease, run by Avid Radiopharmaceuticals at 2 sites 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 13 inclusion and 9 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 7 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 7 Sep 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?
Test-Retest Reproducibility (time frame: 80-100 minutes postdose). 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?
On the ClinicalTrials.gov record for NCT01992380, which also lists 1 linked publication.
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 7 Sep 2020.