Alzheimer's Disease (AD), Cortical Basal Syndrome (CBS), Frontal Temporal Dementia (FTD), Progressive Supranuclear Palsy (PSP)
Conditions
Brief summary
The overall goal of this imaging trial is to characterize \[18F\]MNI-815, a PET radioligand for imaging Tau.
Interventions
DRUG[18F]MNI-815 (MNI-815)
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.
Sponsors
Life Molecular Imaging SA
Molecular NeuroImaging
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
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: * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brain uptake of [18F]MNI-815 | 18 months | 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. |
Countries
United States
Outcome results
None listed