Clinical trial NCT05641688: [18F]PI-2620 Phase 3 Histopathological Study
Official title: An Open-label, Non-randomized, Multi-center Pivotal Phase 3 Study to Evaluate the Efficacy and Safety of PET Imaging With [18F]PI-2620 for the Detection of Tau Deposition When Compared to Post-mortem Histopathology (ADvance)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Alzheimer Disease
Lead sponsor: Life Molecular Imaging SA
Sponsor class: INDUSTRY
First posted: 2022-12-08
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is an open-label, multi-center, non-randomized pivotal Phase 3 study to assess the efficacy and safety of PET imaging with \[18F\]PI-2620 for detection of tau deposition in subjects with Alzheimer's disease (AD) and controls during lifetime when compared to histopathology obtained after death and completion of brain autopsy.


Eligibility criteria: Inclusion Criteria:

Only subjects who meet all of the following criteria will be eligible for enrollment into the study:

1. Males and females aged 50 years and over
2. Have a projected life expectancy of ≤ 1 year as determined by the investigator (terminal medical condition including but not limited to end-stage dementia, end-stage congestive heart failure, end-stage chronic obstructive pulmonary disease (COPD), or end-stage cancer)
3. Written informed consent obtained from the subject and/or the subject's legally authorized representative (LAR), as applicable, to consent for study procedures and brain donation (consent consistent with the legal requirements of the State in which the subject dies)
4. Can tolerate study procedures including lying down in PET scanner. The investigator will carefully assess each subject and use medical judgment to determine whether the subject can tolerate the imaging procedure

Exclusion Criteria:

Subjects will be excluded from the enrollment if they:

1. Are receiving aggressive treatment with life sustaining measures (e.g. receiving chemotherapy; palliative chemotherapy is allowed)
2. Are known to have a structural brain lesion that would interfere either with PET imaging or pathological assessment (e.g. lesions are typically \> 2 cm at their greatest extent and may include stroke, primary or metastatic neoplasm, other tumors or cystic lesions. Subjects with a history of major stroke or traumatic brain injury or other structural lesion as well as cases with a history of primary Central Nervous System (CNS) neoplasm or known metastatic cancer must be discussed with the study sponsor prior to enrollment)
3. Have suspected encephalopathy due to alcoholism or end-stage liver disease
4. Are known to have a Glomerular Filtration Rate below \< 15 mL/min
5. Have received an investigational or approved therapy directly targeting amyloid or tau
6. Are females of childbearing potential who are pregnant, lactating or breastfeeding, or who are not using adequate contraception
7. Have 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 (in case an MRI is planned to be performed)

Primary outcomes:
measure: Diagnostic Efficacy of the visual assessment of [18F]PI-2620 PET imaging, in correctly differentiating tau neurofibrillary pathology associated with AD (NFT Score of B0 or B1 = negative)
timeFrame: At autopsy, until study completion with an average of 1 year
Secondary outcomes:
measure: Diagnostic Efficacy of the visual assessment of [18F]PI-2620 PET imaging, in correctly differentiating tau neurofibrillary pathology associated with AD (NFT Score of B0, B1 or B2 = negative)
timeFrame: At autopsy, until study completion with an average of 1 year
measure: Diagnostic efficacy of the visual assessment of [18F]PI-2620 PET imaging, in correctly differentiating levels of AD neuropathologic change (ADNC) ('No' or 'Low' levels of ADNC = negative)
timeFrame: At autopsy, until study completion with an average of 1 year
measure: Diagnostic efficacy of the visual assessment of [18F]PI-2620 PET imaging, in correctly differentiating levels of ADNC ('No', 'Low' or 'Intermediate" levels of ADNC = negative)
timeFrame: At autopsy, until study completion with an average of 1 year
measure: Inter-reader agreement for the visual assessment of [18F]PI-2620 PET images
timeFrame: Baseline scan
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Sun City
country: United States
facility: Banner Sun Health Research Institute
state: Arizona
city: Los Angeles
country: United States
facility: UC Los Angeles
state: California
city: Murrieta
country: United States
facility: Esperanza Clinical
state: California
city: San Francisco
country: United States
facility: Sutter Health
state: California
city: Hialeah
country: United States
facility: Galiz Research
state: Florida
city: Jacksonville
country: United States
facility: UF College of Medicine - Jacksonville
state: Florida
city: Lady Lake
country: United States
facility: K2 Medical Research
state: Florida
city: Maitland
country: United States
facility: ClinCloud Research
state: Florida
city: Maitland
country: United States
facility: K2 Medical Research
state: Florida
city: Miami
country: United States
facility: Miami Jewish Health Systems
state: Florida
city: Sarasota
country: United States
facility: The Roskamp Institute
state: Florida
city: Winter Park
country: United States
facility: Charter Research
state: Florida
city: Braintree
country: United States
facility: Alzheimer's Disease Center
state: Massachusetts
city: Plymouth
country: United States
facility: Headlands Research
state: Massachusetts
city: Lincoln
country: United States
facility: Be Well Clinical Studies
state: Nebraska
city: Lebanon
country: United States
facility: Darthmouth-Hitchcock Medical Center
state: New Hampshire
city: East Syracuse
country: United States
facility: Velocity Clinical Research
state: New York
city: Syracuse
country: United States
facility: Ichor Research
state: New York
city: Charlotte
country: United States
facility: American Carolina Clinical Research LLC
state: North Carolina
city: Beachwood
country: United States
facility: Insight Clinical Trials LLC
state: Ohio
city: Centerville
country: United States
facility: Valley Medical Research
state: Ohio
city: Dallas
country: United States
facility: Baylor Research Institute
state: Texas
city: Kerrville
country: United States
facility: Sante Clinical Research
state: Texas
city: Round Rock
country: United States
facility: Be Well Clinical Studies
state: Texas
Study officials:
affiliation: Banner Health
name: Alireza Atri, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Life Molecular Imaging
name: Andrew Stephens, MD, PhD
role: STUDY_DIRECTOR
References: