An Open Label, Single Center Study, to evaluate the Safety and Imaging Characteristics of [18F]PI-2620 as PET Radioligand for Imaging Tau deposition in the brains of subjects with amnestic mild cognitive impairment (aMCI) and mild to moderate Alzheimer’s disease (AD) in comparison with non-demented controls - Evaluation of Tau depositions with [18F]PI-2620 PET in aMCI and AD

ife Molecular Imaging SA0 sites120 target enrollmentMay 30, 2019

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

May 30, 2019

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

ife Molecular Imaging SA

Eligibility Criteria

Inclusion Criteria

•Inclusion Criteria (for all subjects)
•Males and females aged 50 to 90 years
•Able to understand, sign and date written informed consent or having a legally authorized representative or caregiver to do it (if subject do not have the capacity to consent)
•The subject has an appropriate caregiver capable of accompanying subject, if necessary
•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 salpingectomy or bilateral oophorectomy) or post\-menopausal for at least 1 year (no menses for 12 months without an alternative medical cause). If they are of child\-bearing potential, must commit to use of a highly effective contraceptive measure as defined by the Clinical Trial Facilitation Group for the duration of the study
•Male subjects and their partners of childbearing potential must commit to the use of a highly effective method of contraception for a minimum of one week following each PET scan
•Male subjects must commit to not donate sperm for a minimum of one week after each PET scan.
•Inclusion criteria for Non\-demented control subjects
•Healthy with no clinically relevant finding on physical examination at screening and upon reporting for the \[18F]PI\-2620 imaging visit

Exclusion Criteria

•Exclusion Criteria (for all subjects)
•Current or prior history of any alcohol or drug abuse (self\-reported)
•Laboratory tests with clinically significant abnormalities and/or clinically significant unstable medical illness equivalent to CTC v5\.0 (common toxicity criteria) toxicities greater than grade 2
•Evidence of clinically significant disease that is expected to interfere with cognitive assessments or the ability to complete the study procedures
•Subject has received an investigational drug including treatments
•targeting AB or tau within 3 months of screening
•Prior participation in other research imaging studies resulting in radiation exposure greater than 40 mSv in aMCI and mild or moderate AD over the previous 12 months prior to screening. Prior participation in other research imaging studies in NDCs over the previous 12 months prior to screening.
•Pregnant, lactating or breastfeeding
•MRI exclusion criteria include: Findings of cerebrovascular disease (more than two lacunar infarcts, any territorial infarct \>1 cm3, or deep white matter abnormality corresponding to an overall Fazekas scale of 3 with at least one confluent hyperintense lesion on the Fluid\-Attenuated Inversion Recovery (FLAIR) sequence that is ?20 mm in any dimension), infectious disease, space\-occupying lesions, normal pressure hydrocephalus or any other abnormalities associated with Central Nervous System (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