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Alzheimer's Disease (AD)Phase 1NCT02370524

Quantitative Evaluation of [18F]T807 as a Potential PET Radioligand for Imaging Tau in Patients With Alzheimer's Disease

A Phase 1 study testing [18F]T807 in people with Alzheimer's Disease (AD), run by Molecular NeuroImaging at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this exploratory imaging study is to further characterize [18F]T807, an investigational PET radioligand for imaging Tau (thought to be a downstream biomarker indicative of neurodegeneration in conditions such as AD). Read more about this study

Who is it for?
Ages 20 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Alzheimer's Disease (AD)
What is being tested?
[18F]T807
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
Jan 2015to Jan 2016
Phase
Phase 1
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 20 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • For all Subjects:
  • Written informed consent or assent is obtained
  • Female subjects/volunteers must be either surgically sterile (by means of hysterectomy, bilateral oophorectomy, or tubal ligation) or post-menopausal for at least 1 year or, if they are of childbearing potential, must commit to the use of two effective contraception methods for the duration of the study.
  • Male subjects/volunteers and their partners of childbearing potential must commit to the use of two effective methods of contraception, one of which should be a barrier method for male subjects.
  • Prodromal and Mild Alzheimer's Disease Subjects
  • Males and females aged between 50 and 90 years.
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  • Study partner has noticed a recent gradual decrease in the subject's memory (e.g., over the prior 12 months), which the subject may or may not be aware of.
  • For prodromal subjects, abnormal memory function at screening or 4 weeks prior to screening based on the FCSRT-IR of:Free recall <17, or Total recall <40, or Free recall <20 and total recall <42.
  • Individuals with mild AD must meet the criteria based on the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association and Diagnostic and Statistical Manual of Mental Disorders, Version 5, criteria. This evidence may be compiled during screening but must be fully documented in the subject's study file before the baseline visit.
  • Have an MMSE (Folstein et al. 1975) score at screening >20.
  • Have an Amyvid (florbetapir F 18 injection) scan at screening that demonstrates amyloid binding based on qualitative analysis (visual read) that meets the criteria for AD.
  • Modified Hachinski Ischemia Scale (Moroney et al. 1997) score of ≤ 4.
  • A neuroimaging evaluation of the brain by MRI that supports a diagnosis of AD with no evidence of focal disease to account for dementia or MRI exclusion criteria.
  • Medications taken for symptomatic treatment of AD must be maintained on a stable dosage regimen for at least 4 weeks before the [18F]T807 imaging visit.
  • Able to participate in all scheduled evaluations.
  • The subject has an appropriate caregiver or community dwelling with a caregiver capable of accompanying the subject on all visits to the center as judged by the investigator.
  • In the opinion of the investigator, the subject and caregiver will be compliant and have a high probability of completing the study.
  • Healthy Volunteers
  • Males and females aged between 20 and 90 years. Younger healthy controls will be aged 20-49 and older healthy controls will be aged 50-90.
  • Healthy volunteers with no clinically relevant findings on physical examination at screening and upon reporting for the [18F]T807 imaging visit.
  • No suspicion of cognitive impairment/early dementia from MMSE as judged by the investigator (MMSE>28).
  • No concomitant medications, over-the-counter, supplement, or any other agent intended to improve cognition or prevent cognitive decline
  • A negative Amyvid (florbetapir F 18 injection) scan at screening based on qualitative analysis (visual read).

Who cannot join

  • For All subjects:
  • Current or prior history of any alcohol or drug abuse.
  • Severe systemic disease based on history and physical examination.
  • Positive result on urine screen for illicit drugs.
  • Laboratory tests with clinically significant abnormalities
  • Clinically significant unstable medical or psychiatric illness.
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  • Positive test for hepatitis B or C or HIV.
  • Prior participation in other research protocols or clinical care in the last year such that radiation exposure is >15 mSv and participation in this study would require the subject/volunteer to exceed the annual limits.
  • Pregnancy or breastfeeding.
  • Current or prior history of coagulopathy.
  • The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
  • History of significant drug and/or food allergies, anaphylactic/anaphylactoid reaction to any allergen.
  • Contraindication for arterial cannulation.
  • Unsuitable veins for repeated venipuncture.
  • MRI exclusion criteria include: non-AD pathology such as infectious disease, space-occupying lesions, normal pressure hydrocephalus, or any other abnormalities associated with significant CNS disease
  • Any lacunar infarct in a strategically important location known to lead to cognitive impairment such as the thalamus, hippocampus of either hemisphere, or head of the left caudate
  • Severe sub-cortical microvascular disease (Fazekas score of 3 for deep white matter hyperintensities) (Fazekas et al. 1987)
  • Territorial infarct or macroscopic hemorrhage (>10 mm)
  • Implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips or other medical implants that have not been certified for MRI, or history of claustrophobia in MRI
  • Observed claustrophobia at screening
  • Ferromagnetic foreign bodies, such as metal shrapnel or bullet fragments, need to be considered on an individual basis

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Molecular NeuroImaging, LLC

    New Haven, Connecticut, 06510

Other trials in United States

About this study

The primary objective of this exploratory imaging study is to further characterize [18F]T807, an investigational PET radioligand for imaging Tau (thought to be a downstream biomarker indicative of neurodegeneration in conditions such as AD).

Being tested
[18F]T807
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]T807Drug

    Also called Amyvid, [18F]florbetapir

    All enrolled subjects will undergo an [18F]T807 PET imaging visit. In addition, subjects with AD and aged volunteers will have one PET scan with Amyvid (florbetapir F 18 injection) as part of the screening activities to measure Aβ in the brain.

Study groups in NCT02370524
Study groupRoleWhat they receive
[18F]T807ExperimentalAt the [18F]T807 PET imaging visit, subjects will be given a bolus injection of no more than 10 mCi (370 MBq) of [18F]T807
Receives: Drug: [18F]T807

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quantitative evaluation of [18F]T807 as a potential PET radioligand for imaging Tau in patients with clinically characterized tauopathies

    To further characterize [18F]T807, an investigational PET radioligand for imaging Tau (thought to be a downstream biomarker indicative of neurodegeneration in conditions such as AD) and to assess the full quantitative evaluation of the PET outcome measures using [18F]T807 by pharmacokinetic (PK) modeling in order to derive a volume of distribution (VT) of [18F]T807 using arterial input function.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionJan 2016
  4. Study completionJan 2016

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02370524
Sponsor's protocol ID
[18F]T807
Status last verified
Mar 2017
First submitted
17 Feb 2015
Last updated
8 Mar 2017
Results posted
No
Data monitoring committee
No

Publications

  • Fazekas F, Chawluk JB, Alavi A, Hurtig HI, Zimmerman RA. MR signal abnormalities at 1.5 T in Alzheimer's dementia and normal aging. AJR Am J Roentgenol. 1987 Aug;149(2):351-6. doi: 10.2214/ajr.149.2.351.

    PubMed 3496763

  • Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.

    PubMed 1202204

  • Moroney JT, Bagiella E, Desmond DW, Hachinski VC, Molsa PK, Gustafson L, Brun A, Fischer P, Erkinjuntti T, Rosen W, Paik MC, Tatemichi TK. Meta-analysis of the Hachinski Ischemic Score in pathologically verified dementias. Neurology. 1997 Oct;49(4):1096-105. doi: 10.1212/wnl.49.4.1096.

    PubMed 9339696

  • Barret O, Alagille D, Sanabria S, Comley RA, Weimer RM, Borroni E, Mintun M, Seneca N, Papin C, Morley T, Marek K, Seibyl JP, Tamagnan GD, Jennings D. Kinetic Modeling of the Tau PET Tracer 18F-AV-1451 in Human Healthy Volunteers and Alzheimer Disease Subjects. J Nucl Med. 2017 Jul;58(7):1124-1131. doi: 10.2967/jnumed.116.182881. Epub 2016 Dec 1.

    PubMed 27908967

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [18F]T807 in people with Alzheimer's Disease (AD), run by Molecular NeuroImaging 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 23 inclusion and 21 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 8 Mar 2017. 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?

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?

Quantitative evaluation of [18F]T807 as a potential PET radioligand for imaging Tau in patients with clinically characterized tauopathies (time frame: 1 year). 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 NCT02370524, which also lists 4 linked publications.

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 8 Mar 2017.

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