Brief Title
Evaluation of Imaging Characteristics of [18F]PI-2620 PET in AD and PSP Patients Using High and Low Specific Activity
Official Title
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 Patients With Mild to Moderate Alzheimer's Disease (AD) and Patients With Progressive Supranuclear Palsy (PSP) After i.v. Application of [18F]PI-2620 With High and Low Specific Activity
Brief Summary
This is an open-label study without randomisation. All eligible patients will receive two
administrations of the investigational imaging agent [18F]PI-2620 at a radioactive dose of
185 MBq, one with high specific activity (≤ 5 µg tracer mass dose), another one with low
specific activity (40-50 µg tracer mass dose).
Detailed Description
This is an open-label, single center study to visually assess and quantitatively compare
brain PET images obtained after application of [18F]PI-2620 with different specific
activities: 1) High specific activity (low mass dose): 185 MBq containing a maximum mass dose
of ≤5 μg in up to 10 mL and 2) Low specific activity (high mass dose): 185 MBq containing a
maximum mass dose of 40-50 μg in up to 10 mL).
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Comparability of visual assessment of PI-2620 tau PET images obtained after injection of high specific activity and low specific activity in AD and PSP patients.
Secondary Outcome
Comparability of quantitative assessment of PI-2620 tau PET images obtained after injection of high specific activity and low specific activity in AD and PSP patients.
Condition
Alzheimer Disease
Intervention
[18F]-PI2620
Study Arms / Comparison Groups
Tau deposition in the brains of Alzheimer Disease and Progressive Supranuclear Palsy patients
Description: All patients will receive two administrations of [18F]PI-2620 at a radioactive dose of 185 MBq, one with high specific activity (≤ 5 µg tracer mass dose), another one with low specific activity (40-50 µg tracer mass dose)
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
10
Start Date
November 12, 2020
Completion Date
June 2022
Primary Completion Date
June 2022
Eligibility Criteria
Inclusion Criteria:
- Males and females aged 50-80 years
- Able to understand, sign and date written informed consent, which is confirmed by the
judgment of the referring physician
- Written informed consent must be obtained before any assessment is performed
- Prior evaluable MRI
- Female patients 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 patients 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 patients must commit to not donate sperm for a minimum of one week after each PET
scan.
Inclusion Criteria for mild-moderate AD patients
- Patients with mild or moderate AD in accordance with NIA-AA guidelines 2011
- Have a CDR score of ≥ 0.5 at screening
- Have an MMSE score of ≤ 24 at screening
- Prior evaluable amyloid PET imaging confirming presence of beta-amyloid brain
pathology
- Medications taken for symptomatic treatment of AD must be maintained on a stable
dosage regimen for at least 30 days before the [18F]PI-2620 PET imaging visits
Inclusion Criteria for patients with probable PSP
- Patients with a clinical diagnosis of probable PSP based on the Movement Disorder
Society criteria (Höglinger et al., 2017).
- Have a PSP rating score between 20 - 60
- 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 patients)
- 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
- Patient has received an investigational drug including treatments targeting
amyloid-beta plaques or tau within 3 months of screening
- Pregnant (or intention of getting 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
- Unwilling and/or unable to cooperate with study procedures
Gender
All
Ages
50 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Andrew Stephens, MD, PhD, +49 (0)30 461 1246 03, [email protected]
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT04715750
Organization ID
LMT-01-01-19
Responsible Party
Sponsor
Study Sponsor
Life Molecular Imaging GmbH
Collaborators
Life Molecular Imaging SA
Study Sponsor
Andrew Stephens, MD, PhD, Study Director, Life Molecular Imaging GmbH
Verification Date
October 2021