Brief Title
Test-retest Study With [18F]PI-2620 in PSP-RS and NDC
Official Title
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)
Brief 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)
Detailed Description
The imaging characteristics of [18F]PI-2620 using positron emission tomography (PET) in
patients with progressive supranuclear palsy, Richardson's syndrome (PSP-RS) will be
evaluated by a) determining the test-retest variability of the [18F]PI-2620 binding
parameters in brain of patients with PSP-RS and non-demented controls (NDC).
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Test-retest variability of the [18F]PI-2620 binding parameters in brain of patients with PSP-RS and non-demented controls
Secondary Outcome
Compare quantification in terms if test-retest variability in PSP-RS and NDC
Condition
Progressive Supranuclear Palsy
Intervention
[18F]-PI2620
Study Arms / Comparison Groups
Imaging characteristics of [18F]PI-2620 for detection of Tau deposition in the brain of PSP patients
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
15
Start Date
March 10, 2022
Completion Date
December 2022
Primary Completion Date
September 2022
Eligibility Criteria
Inclusion Criteria (for all subjects)
- 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
Inclusion criteria for non-demented controls (NDC)
- 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)
Inclusion Criteria for patients with probable PSP-RS
- 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
Exclusion Criteria (for all subjects)
- Hemoglobin value < 10 g/dL
- 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
- Subjects with clinically significant renal and hepatic dysfunction as judged by the
investigator
- Known hypersensitivity to the active substance or to any of the excipients of
[18F]PI-2620
- Known hypersensitivity to the active substance or to any of the excipients of
Neuraceq®, for NDC only
- Subject has received an investigational drug including treatments targeting
Amyloid-beta or tau within 3 months of screening
- Pregnant (or having the intention of getting pregnant), lactating or breastfeeding
- Unsuitable veins for repeated venipuncture.
- Subject has a contraindication to blood sampling and/or arterial cannulation,
including but not limited to peripheral vascular disease, Raynaud's phenomenon as
determined by abnormal Allen's test or abnormal coagulation profile at screening
- MRI exclusion criteria include but not limited to: 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
- Unwilling and/or unable to cooperate with study procedures
Gender
All
Ages
50 Years - 80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Andrew Stephens, MD, PhD, +49 (0)30 461 1246 03, [email protected]
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT05187546
Organization ID
LMT-02-01-21
Responsible Party
Sponsor
Study Sponsor
Life Molecular Imaging GmbH
Study Sponsor
Andrew Stephens, MD, PhD, Study Director, Life Molecular Imaging
Verification Date
April 2022