Alzheimer Disease, Healthy Volunteers, Progressive Supranuclear Palsy
Conditions
Keywords
PSP, AD, HV
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.
Interventions
DRUG[18F]MNI-952
Subjects will undergo PET imaging using \[18F\]MNI-952, a PET radioligand for imaging tau.
DRUG[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.
Sponsors
Molecular NeuroImaging
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 1 year | Descriptive statistics will be applied to describe the tau deposition by region as measured by \[18F\]MNI-952. |
Countries
United States
Outcome results
None listed