Brief Title
Evaluation of [18F]MNI-952 as a Potential PET Radioligand for Imaging Tau Protein in the Brain
Official Title
Phase 0 Evaluation of [18F]MNI-952 as a Potential PET Radioligand for Imaging Tau Protein in the Brain of Patients With Progressive Supranuclear Palsy or Alzheimer's Disease Compared to Healthy Volunteers
Brief Summary
The overall goal of this imaging trial is to evaluate [18F]MNI-952 (also known as
[18F]UCB-K), a tau targeted PET radioligand.
Detailed Description
The overall goal of this imaging trial is to evaluate [18F]MNI-952 (also known as
[18F]UCB-K), a tau targeted PET radioligand.
- 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.
Study Phase
Early Phase 1
Study Type
Interventional
Primary Outcome
Tracer uptake will be evaluated in regions of interest for analysis of regional [18F]MNI-952 binding/uptake and expressed in SUV by using established methods for normalization for 2 PSP, 2 AD, and 2 HV subjects.
Condition
Progressive Supranuclear Palsy
Intervention
[18F]MNI-952
Study Arms / Comparison Groups
[18F]MNI-952
Description: To evaluate [18F]MNI-952 (also known as [18F]UCB-K), a tau targeted PET radioligand.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
6
Start Date
August 2016
Completion Date
March 6, 2017
Primary Completion Date
March 6, 2017
Eligibility Criteria
Inclusion Criteria:
- Written informed consent must be obtained before any assessment is performed.
- 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
Inclusion Criteria for healthy volunteer subjects:
- 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
Inclusion Criteria for subjects with a diagnosis of probable Alzheimer's disease (AD):
- 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)
- 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 30 days before the 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/or the
subject's legally authorized representative or caregiver (if applicable).
Inclusion Criteria for subjects with a diagnosis of probable Progressive Supranuclear Palsy
(PSP):
- 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.
- A brain MRI that supports a diagnosis of PSP, with no evidence of focal disease or MRI
exclusion criteria.
- 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).
Exclusion Criteria:
- 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.
- MRI exclusion criteria include: Findings of cerebrovascular disease (more than two
lacunar infarcts, any territorial infarct >1cm3, or deep white matter abnormality
corresponding to an overall Fazekas scale of 3 with at least one confluent
hyperintense lesion on the FLAIR sequence that is ≥20 mm in any dimension), 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.
Exclusion criteria for subjects with AD:
- Has received treatment that targeted amyloid-β or tau within the last 3 months.
Gender
All
Ages
18 Years - 90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Jennifer Madonia, PA-C, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03080051
Organization ID
[18F]MNI-952
Responsible Party
Sponsor
Study Sponsor
Molecular NeuroImaging
Study Sponsor
Jennifer Madonia, PA-C, Principal Investigator, Molecular NeuroImaging
Verification Date
October 2017