Evaluation of [18F]MNI-952 as a Potential PET Radioligand for Imaging Tau Protein in the Brain
NCT ID: NCT03080051
Last Updated: 2017-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
EARLY_PHASE1
6 participants
INTERVENTIONAL
2016-08-31
2017-03-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* To characterize \[18F\]MNI-952, a PET radioligand for imaging tau.
* To visually and quantitatively assess brain uptake and pharmacokinetics of \[18F\]MNI-952, a PET imaging marker for tau pathology in individuals with Progressive Supranuclear Palsy (PSP) or Alzheimer's disease (AD) and compare with healthy volunteers (HV).
* To evaluate the safety of a single injection of \[18F\]MNI-952.
* To compare the distribution of tau (using \[18F\]MNI-952) and Aâ (using florbetapir) in AD subjects.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
[18F]MNI-952
To evaluate \[18F\]MNI-952 (also known as \[18F\]UCB-K), a tau targeted PET radioligand.
[18F]MNI-952
Subjects will undergo PET imaging using \[18F\]MNI-952, a PET radioligand for imaging tau.
[18F]Florbetapir
Subjects with Alzheimer's disease will receive a \[18F\]florbetapir scan to compare distribution of tau in the brain compared to that of \[18F\]MNI-952.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
[18F]MNI-952
Subjects will undergo PET imaging using \[18F\]MNI-952, a PET radioligand for imaging tau.
[18F]Florbetapir
Subjects with Alzheimer's disease will receive a \[18F\]florbetapir scan to compare distribution of tau in the brain compared to that of \[18F\]MNI-952.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Female subjects must be documented by medical records or physician's note to 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 child-bearing potential, must commit to use 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.
* Male subjects must not donate sperm for study duration and for 90 days following participation.
* Willing and able to cooperate with study procedures
* Males and females aged \<55 years. Healthy with no clinically relevant finding on physical examination at screening and upon reporting for the \[18F\]MNI-952 imaging visit.
* No neurologic impairment as judged by the investigator
* No family history of Alzheimer's disease or neurological disease associated with dementia
* Have a CDR score=0
* Males and females aged between 50 and 90 years.
* Have probable Alzheimer's disease, based on the NINCDS/ADRDA and DSM-IV criteria.
* Have a CDR score of 0.5 or greater at screening.
* Have an MMSE score ≤ 28.
* Have a screening \[18F\]florbetapir PET imaging demonstrating amyloid binding based on qualitative (visual read)
* Males and females aged 50 to 90 years.
* Has a clinical diagnosis of PSP based on the NINDS and Society for PSP criteria (Litvan, et al 1996).
* Have screening DaTSCAN SPECT imaging demonstrating evidence of dopamine transporter deficit based on qualitative (visual) read.
Exclusion Criteria
* The subject has an appropriate caregiver capable of accompanying subject, if necessary.
* Signed and dated written informed consent obtained from the subject and/or the subject's legally authorized representative or caregiver (if applicable).
* Medications taken for symptomatic treatment of PSP must be maintained on a stable dosage regimen for at least 30 days before screening visit.
* The subject has an appropriate caregiver capable of accompanying subject, if necessary.
* Signed and dated written informed consent obtained from the subject and the subject's legally authorized representative or caregiver (if applicable).
* Current or prior history of any alcohol or drug abuse.
* Laboratory tests with clinically significant abnormalities and/or clinically significant unstable medical illness.
* Subject has received an investigational drug or device within 30 days of screening
* Prior participation in other research protocols or clinical care in the last year such that radiation exposure exceeds the effective dose of 50 mSv, which would be above the acceptable annual limit established by the US Federal Guidelines.
* Pregnancy, lactating or breastfeeding.
* Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease.
* Unsuitable veins for repeated venipuncture.
* 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-β or tau within the last 3 months.
18 Years
90 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Molecular NeuroImaging
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jennifer Madonia, PA-C
Role: PRINCIPAL_INVESTIGATOR
Molecular NeuroImaging
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Molecular NeuroImaging, LLC
New Haven, Connecticut, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
[18F]MNI-952
Identifier Type: -
Identifier Source: org_study_id