An Open Label, Single Center Study to Evaluate the Safety and Test-retest Characteristics of [18F]PI-2620 as PET Radioligand for Imaging Tau Deposition in the Brains of Patients With Progressive Supranuclear Palsy Richardson Syndrome (PSP-RS) Compared to Non-demented Controls (NDC)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The overall goal of this protocol is to evaluate the imaging characteristics of [18F]PI-2620 using positron emission tomography (PET) in patients with progressive supranuclear palsy, Richardson's syndrome (PSP-RS)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: Accepts Healthy Volunteers
View:

• Males and females aged 50-80 years

• Able to understand, sign and date written informed consent

• Signed and dated written informed consent obtained from the subject

• The subject has an appropriate caregiver capable of accompanying subject, if necessary

• Have an Montreal Cognitive Assessment (MoCa) score ≥ 27

• 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 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 90 days following each PET scan

• Male subjects must commit to not donate sperm for a minimum of 90 days after each PET scan

• Willing and able to cooperate with study procedures including lying flat and still on the scanning bed for 60 minutes

• Healthy with no clinically relevant finding on physical examination at screening

• No cognitive impairment from neuropsychological battery as judged by the investigator

• A brain MRI without evidence of significant neurological pathology

• A beta-amyloid Neuraceq® PET demonstrating a negative beta-amyloid status

• No signs of movement disorder as judged by Progressive Supranuclear Palsy Rating Scale (PSPRS), Movement Disorder Society - Unified Parkinson's Disability Rating Scale (MDS-UPDRS) and Progressive Supranuclear Palsy Clinical Deficits Scale (PSP-CDS)

• Patients with a clinical diagnosis of probable PSP-RS based on the Movement Disorder Society criteria (Höglinger et al., 2017)

• Medications taken for symptomatic treatment of PSP must be maintained on a stable dosage regimen for at least 30 days before the [18F]PI-2620 PET imaging visits

Locations
Other Locations
Germany
Ludwig-Maximilians-Universität München
Recruiting
Munich
Contact Information
Primary
Audrey Perrotin, PhD
GRA@life-mi.com
+49 (0)30 461 1246 03
Backup
Aleksandar Jovalekic, PhD
GRA@life-mi.com
+49 (0)30 461 1246 03
Time Frame
Start Date: March 10, 2022
Estimated Completion Date: December 2023
Participants
Target number of participants: 15
Treatments
Experimental: Imaging characteristics of [18F]PI-2620 for detection of Tau deposition in the brain of PSP patients
All eligible PSP patients will receive two injections of the investigational imaging agent [18F]PI-2620: at a baseline PET imaging session and at a follow-up PET imaging session to evaluate the test-retest imaging characteristics. 10 PSP patients will be required to complete the study arm.
Experimental: Imaging characteristics of [18F]PI-2620 for detection of Tau deposition in the brain of NDC subjects
All eligible non-demented control (NDC) subjects will receive two injections of the investigational imaging agent [18F]PI-2620: at a baseline PET imaging session and at a follow-up PET imaging session to evaluate the test-retest imaging characteristics. 5 NDC subjects will be required to complete the study arm.
Sponsors
Leads: Life Molecular Imaging GmbH

This content was sourced from clinicaltrials.gov

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