AzTrials
AzTrials

Alzheimer's Disease (AD)Early Phase 1NCT02531360

Evaluation of [18F]MNI-815 as a Potential PET Radioligand for Imaging Tau Protein in the Brain of Patients With Tauopathies

A Early Phase 1 study testing [18F]MNI-815 (MNI-815) in people with Alzheimer's Disease (AD) and Progressive Supranuclear Palsy (PSP), 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
Search all trials

Trial summary

The overall goal of this imaging trial is to characterize [18F]MNI-815, a PET radioligand for imaging Tau. Read more about this study

Who is it for?
Ages 50 to 90 yearsHealthy volunteers can take part
What is being tested?
[18F]MNI-815 (MNI-815)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteUnited States
Study dates
May 2015to Aug 2016
Phase
Early 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 50 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • For all subjects:
  • Written informed consent must be obtained before any assessment is performed.
  • Female subjects 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 child-bearing potential, must commit to use of a barrier contraception method for the duration of the study.
  • Male subjects and their partners of childbearing potential must commit to the use of two methods of contraception, one of which is a barrier method for male subjects for the study duration
  • Willing and able to cooperate with study procedures
  • Healthy Control subjects:
Show all 45Show fewer
  • Males and females aged between 50 - 70 years. Healthy with no clinically relevant finding on physical examination at screening and upon reporting for the [18F]MNI-815 imaging visit.
  • No cognitive impairment from neuropsychological battery as judged by the investigator
  • Have a CDR score=0
  • Has FBB PET imaging demonstrating no evidence for significant amyloid binding based on qualitative (visual read) and quantitative analysis.
  • Modified Hachinski Ischemia Scale score of ≤ 4.
  • Prodromal or Moderate Alzheimer's Disease subjects:
  • Males and females aged between 50 - 90 years.
  • Have prodromal or moderate Alzheimer's disease, based on the NINCDS/ADRDA and DSM-IV criteria.
  • Have a CDR score of 0.5 for prodromal AD subjects and CDR > 1.0 for moderate AD subject at screening.
  • Has a FBB PET imaging demonstrating amyloid binding based on qualitative (visual read) and quantitative analysis.
  • Modified Hachinski Ischemia Scale score of ≤ 4.
  • A brain 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 1 month before the [18F]MNI-815 imaging visit.
  • The subject has an appropriate caregiver capable of accompanying subject on all visits.
  • Signed and dated written informed consent obtained from the subject and, when applicable, the subject's legally authorized representative or caregiver.
  • Frontotemporal Dementia subjects:
  • Has a clinical diagnosis of FTD based on consensus for clinical diagnosis of frontotemporal dementia criteria (Neary, et al 1998)
  • Has a FBB PET imaging demonstrating no evidence of significant amyloid binding based on qualitative (visual read) and quantitative analysis.
  • A brain MRI that supports a diagnosis of FTD, with no evidence of focal disease to account for dementia or MRI exclusion criteria.
  • Medications taken for symptomatic treatment of cognitive dysfunction must be maintained on a stable dosage regimen for at least 1 month before the screening visit.
  • The subject has an appropriate caregiver capable of accompanying subject on all visits to the center.
  • Signed and dated written informed consent obtained from the subject and, when applicable, the subject's legally authorized representative or caregiver.
  • Modified Hachinski Ischemia Scale score of ≤ 4.
  • Progressive Supranuclear Palsy subjects:
  • Has a clinical diagnosis of PSP based the NINDS and Society for PSP criteria (Litvan, et al 1996)
  • Has FBB PET imaging demonstrating no evidence of significant amyloid binding based on qualitative (visual read) and quantitative analysis.
  • A brain MRI that supports a diagnosis of PSP, with no evidence of focal disease to account for dementia or MRI exclusion criteria.
  • Medications taken for treatment of PSP symptoms must be maintained on a stable dosage regimen for at least 1 month before the screening visit.
  • The subject has an appropriate caregiver capable of accompanying subject on all visits to the center.
  • Signed and dated written informed consent obtained from the subject and, when applicable the subject's legally authorized representative or caregiver.
  • Modified Hachinski Ischemia Scale score of ≤ 4.
  • Corticobasal Syndrome Subjects:
  • Has a clinical diagnosis of CBS based on consensus criteria for possible or probable corticobasal degeneration (Armstrong et al, 2013)
  • Has a FBB PET imaging demonstrating no evidence of significant amyloid binding based on qualitative (visual read) and quantitative analysis.
  • A brain MRI that supports a diagnosis of CBS, with no evidence of focal disease to account for dementia or MRI exclusion criteria.
  • Medications taken for treatment of CBS symptoms must be maintained on a stable dosage regimen for at least 1 month before the screening visit.
  • The subject has an appropriate caregiver capable of accompanying subject on all visits to the center.
  • Signed and dated written informed consent obtained from the subject and, when applicable, the subject's legally authorized representative or caregiver.
  • Modified Hachinski Ischemia Scale score of ≤ 4.

Who cannot join

  • For all subjects
  • Current or prior history of any alcohol or drug abuse.
  • Laboratory tests with clinically significant abnormalities and/or clinically significant unstable medical illness.
  • Prior participation in other research protocols or clinical care in the last year such that radiation exposure is >15 mSv and would exceed the annual limits.
  • Pregnancy or breastfeeding.
  • Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease.
Show all 21Show fewer
  • Unsuitable veins for repeated venipuncture.
  • MRI exclusion criteria include: Pathology that may be responsible for the neurologic status of the patient such as infectious disease, space-occupying lesions, normal pressure hydrocephalus or any other abnormalities associated with CNS disease,
  • Implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips and other medical implants that have not been certified for MRI, or history of claustrophobia in MRI.
  • Has received treatment that targeted amyloid-beta or tau within the last 24 months.
  • Has a FBB PET imaging demonstrating no evidence of significant amyloid binding irrespective of other previous measurements of beta amyloid that may be available for review.
  • Has FBB PET imaging with evidence of significant amyloid binding irrespective of other previous measurements of beta amyloid that may be available for review.
  • Has received treatment that targeted tau within the last 24 months.
  • Have any other neurological condition other than CBS or PSP that could account for cognitive or motor deficits including: Specifically:
  • A diagnosis of idiopathic Parkinson's disease or Lewy body dementia and/or have a prominent and sustained response to levodopa therapy;
  • History of repeated strokes with stepwise progression of parkinsonian features or history of major stroke
  • FTD subjects:
  • Has FBB PET imaging with evidence of significant amyloid binding irrespective of other previous measurements of beta amyloid that may be available for review.
  • Has received treatment that targeted tau within the last 24 months.
  • Healthy subjects:
  • •Has FBB PET imaging with evidence of significant amyloid binding irrespective of other previous measurements of beta amyloid that may be available for review.

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

Official title: Phase 0 Evaluation of [18F]MNI-815 as a Potential PET Radioligand for Imaging Tau Protein in the Brain of Patients With Alzheimer's Disease and Other Tauopathies

The overall goal of this imaging trial is to characterize [18F]MNI-815, a PET radioligand for imaging Tau.

Being tested
[18F]MNI-815 (MNI-815)
Medical subject headings
Alzheimer Disease, Supranuclear Palsy, Progressive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [18F]MNI-815 (MNI-815)Drug

    Also called [18F]MNI-815, FBB, [18F]Florbetaben

    All enrolled subjects will undergo an [18F]MNI-815 PET imaging visit. As a part of the screening visit, subjects will undergo [18F]florbetaben (FBB) PET imaging to determine if they have significant amyloid deposition.

Study groups in NCT02531360
Study groupRoleWhat they receive
[18F]MNI-815 (MNI-815)ExperimentalAt the [18F]MNI-815 PET imaging visit, subjects will be injected with no more than 10mCi of [18F]MNI-815
Receives: Drug: [18F]MNI-815 (MNI-815)

What is being measured

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

  1. Brain uptake of [18F]MNI-815

    The PET imaging outcome measure to evaluate tau burden will be the standardized uptake value (SUV), which will be calculated for the areas of interest by using the established methods for normalizing to subject weight and injected dose.

    Measured: 18 months

Timeline

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

  1. First posted24 Aug 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionJul 2016
  4. Study completionAug 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
Early Phase 1
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02531360
Sponsor's protocol ID
MNI-815
Status last verified
Dec 2016
First submitted
9 Jun 2015
Last updated
16 Dec 2016
Results posted
No
Data monitoring committee
No

Publications

  • Neary D, Snowden JS, Gustafson L, Passant U, Stuss D, Black S, Freedman M, Kertesz A, Robert PH, Albert M, Boone K, Miller BL, Cummings J, Benson DF. Frontotemporal lobar degeneration: a consensus on clinical diagnostic criteria. Neurology. 1998 Dec;51(6):1546-54. doi: 10.1212/wnl.51.6.1546.

    PubMed 9855500

  • Litvan I, Agid Y, Calne D, Campbell G, Dubois B, Duvoisin RC, Goetz CG, Golbe LI, Grafman J, Growdon JH, Hallett M, Jankovic J, Quinn NP, Tolosa E, Zee DS. Clinical research criteria for the diagnosis of progressive supranuclear palsy (Steele-Richardson-Olszewski syndrome): report of the NINDS-SPSP international workshop. Neurology. 1996 Jul;47(1):1-9. doi: 10.1212/wnl.47.1.1.

    PubMed 8710059

  • Armstrong MJ, Litvan I, Lang AE, Bak TH, Bhatia KP, Borroni B, Boxer AL, Dickson DW, Grossman M, Hallett M, Josephs KA, Kertesz A, Lee SE, Miller BL, Reich SG, Riley DE, Tolosa E, Troster AI, Vidailhet M, Weiner WJ. Criteria for the diagnosis of corticobasal degeneration. Neurology. 2013 Jan 29;80(5):496-503. doi: 10.1212/WNL.0b013e31827f0fd1.

    PubMed 23359374

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing [18F]MNI-815 (MNI-815) in people with Alzheimer's Disease (AD) and Progressive Supranuclear Palsy (PSP), 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 45 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 16 Dec 2016. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

Brain uptake of [18F]MNI-815 (time frame: 18 months). 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 NCT02531360, which also lists 3 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 16 Dec 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in