Alzheimer's Disease (AD)
Conditions
Brief summary
The primary objective of this exploratory imaging study is to further characterize \[18F\]T807, an investigational PET radioligand for imaging Tau (thought to be a downstream biomarker indicative of neurodegeneration in conditions such as AD).
Interventions
DRUG[18F]T807
All enrolled subjects will undergo an \[18F\]T807 PET imaging visit. In addition, subjects with AD and aged volunteers will have one PET scan with Amyvid (florbetapir F 18 injection) as part of the screening activities to measure Aβ in the brain.
Sponsors
Institute for Neurodegenerative Disorders
Roche Pharma AG
Molecular NeuroImaging
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
For all Subjects: * Written informed consent or assent is obtained * Female subjects/volunteers 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 of childbearing potential, must commit to the use of two effective contraception methods for the duration of the study. * Male subjects/volunteers and their partners of childbearing potential must commit to the use of two effective methods of contraception, one of which should be a barrier method for male subjects. Prodromal and Mild Alzheimer's Disease Subjects * Males and females aged between 50 and 90 years. * Study partner has noticed a recent gradual decrease in the subject's memory (e.g., over the prior 12 months), which the subject may or may not be aware of. * For prodromal subjects, abnormal memory function at screening or 4 weeks prior to screening based on the FCSRT-IR of:Free recall \<17, or Total recall \<40, or Free recall \<20 and total recall \<42. * Individuals with mild AD must meet the criteria based on the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association and Diagnostic and Statistical Manual of Mental Disorders, Version 5, criteria. This evidence may be compiled during screening but must be fully documented in the subject's study file before the baseline visit. * Have an MMSE (Folstein et al. 1975) score at screening \>20. * Have an Amyvid (florbetapir F 18 injection) scan at screening that demonstrates amyloid binding based on qualitative analysis (visual read) that meets the criteria for AD. * Modified Hachinski Ischemia Scale (Moroney et al. 1997) score of ≤ 4. * A neuroimaging evaluation of the brain by 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 4 weeks before the \[18F\]T807 imaging visit. * Able to participate in all scheduled evaluations. * The subject has an appropriate caregiver or community dwelling with a caregiver capable of accompanying the subject on all visits to the center as judged by the investigator. * In the opinion of the investigator, the subject and caregiver will be compliant and have a high probability of completing the study. Healthy Volunteers * Males and females aged between 20 and 90 years. Younger healthy controls will be aged 20-49 and older healthy controls will be aged 50-90. * Healthy volunteers with no clinically relevant findings on physical examination at screening and upon reporting for the \[18F\]T807 imaging visit. * No suspicion of cognitive impairment/early dementia from MMSE as judged by the investigator (MMSE\>28). * No concomitant medications, over-the-counter, supplement, or any other agent intended to improve cognition or prevent cognitive decline * A negative Amyvid (florbetapir F 18 injection) scan at screening based on qualitative analysis (visual read).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative evaluation of [18F]T807 as a potential PET radioligand for imaging Tau in patients with clinically characterized tauopathies | 1 year | To further characterize \[18F\]T807, an investigational PET radioligand for imaging Tau (thought to be a downstream biomarker indicative of neurodegeneration in conditions such as AD) and to assess the full quantitative evaluation of the PET outcome measures using \[18F\]T807 by pharmacokinetic (PK) modeling in order to derive a volume of distribution (VT) of \[18F\]T807 using arterial input function. |
Countries
United States
Outcome results
None listed