Alzheimer Disease, Healthy Volunteers, Progressive Supranuclear Palsy
Conditions
Keywords
AD, HV, PSP
Brief summary
The overall goal of this imaging trial is to evaluate \[18F\]MNI-958, a tau targeted PET radioligand, in individuals with Alzheimer's disease (AD), Progressive Supranuclear Palsy (PSP), and healthy volunteers (HV).
Interventions
DRUG[18F]MNI-958
Subjects will undergo PET imaging using \[18F\]MNI-958, 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-958.
DRUGDaTscan
DaTscan SPECT imaging will be completed in those PSP subjects who have not previously had DATScan imaging as part of the screening procedures.
Sponsors
Molecular NeuroImaging
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion: * 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 the study duration. * Willing and able to cooperate with study procedures Inclusion Criteria for Healthy Volunteer Subjects: * Males and females aged ≥50 years. Healthy with no clinically relevant finding on physical examination at screening and upon reporting for the \[18F\]MNI-958 imaging visit. * No cognitive impairment from neuropsychological battery as judged by the investigator * Have screening \[18F\]florbetapir PET imaging demonstrating no significant amyloid binding based on qualitative analysis (visual read). * 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 50 to 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 screening or prior (in the last 12 months) \[18F\]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. * Signed and dated written informed consent obtained from the subject and the subject's legally authorized representative or caregiver (if applicable). * The subject has an appropriate caregiver capable of accompanying subject, if necessary. Inclusion Criteria for subjects with a diagnosis of probable Progressive Suprnuclear 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 or prior DaTscan SPECT imaging demonstrating evidence of dopamine transporter deficit based on visual read. * A brain MRI that supports a diagnosis of PSP, with no other evidence of significant neurologic pathology * Medications taken for symptomatic treatment of PSP must be maintained on a stable dosage regimen for at least 30 days before screening visit. * Signed and dated written informed consent obtained from the subject and the subject's legally authorized representative or caregiver (if applicable). * The subject has an appropriate caregiver capable of accompanying subject, if necessary.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tracer uptake will be evaluated in regions of interest for analysis of regional [18F]MNI-958 binding/uptake and expressed in SUV by using established methods for normalization for 3 AD, 3 PSP, and 3 HV subjects. | 1 year | Descriptive statistics will be applied to describe the tau deposition by region as measured by \[18F\]MNI-958. |
Countries
United States
Outcome results
None listed