[18F]PI-2620 Phase 3 Histopathological Study
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)
1 other identifier
interventional
200
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 alzheimer-disease
Started Dec 2022
Typical duration for phase_3 alzheimer-disease
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2022
CompletedStudy Start
First participant enrolled
December 1, 2022
CompletedFirst Posted
Study publicly available on registry
December 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
April 29, 2026
December 1, 2025
4.5 years
November 17, 2022
April 28, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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)
\[18F\]PI-2620 PET scans will be classified as either tau-positive or tau-negative as defined by the reading methodology by each of the 5 independent readers blinded to the clinical and pathology information. NFT scores (as defined in Hyman et al. 2012) will be used as pathology assessment SoT (standard of truth). Tau neurofibrillary pathology associated with AD is defined as either negative with NFT Scores of B0 or B1 or positive NFT Scores of B2 or B3. The \[18F\]PI-2620 PET visual assessment will be compared with the pathology assessment to derive sensitivity and specificity estimates for each individual reader. Sensitivity and specificity are percentages that can range from 0 to 100%. The primary endpoint is considered to be met if for the same 3 out of 5 readers, the lower bound of the 95% CIs for both sensitivity and specificity are ≥ 50%.
At autopsy, until study completion with an average of 1 year
Secondary Outcomes (4)
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)
At autopsy, until study completion with an average of 1 year
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)
At autopsy, until study completion with an average of 1 year
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)
At autopsy, until study completion with an average of 1 year
Inter-reader agreement for the visual assessment of [18F]PI-2620 PET images
Baseline scan
Study Arms (1)
PI-2620 PET Scan
EXPERIMENTALInterventions
The radioligand, \[18F\]PI-2620, will be injected intravenously at a dose of 185 MBq ± 20%
Eligibility Criteria
You may qualify if:
- Only subjects who meet all of the following criteria will be eligible for enrollment into the study:
- Males and females aged 50 years and over
- 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)
- 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)
- 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
You may not qualify if:
- Subjects will be excluded from the enrollment if they:
- Are receiving aggressive treatment with life sustaining measures (e.g. receiving chemotherapy; palliative chemotherapy is allowed)
- 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)
- Have suspected encephalopathy due to alcoholism or end-stage liver disease
- Are known to have a Glomerular Filtration Rate below \< 15 mL/min
- Have received an investigational or approved therapy directly targeting amyloid or tau
- Are females of childbearing potential who are pregnant, lactating or breastfeeding, or who are not using adequate contraception
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Barrow Neurological Institute
Phoenix, Arizona, 85013, United States
Banner Sun Health Research Institute
Sun City, Arizona, 85352, United States
UC Los Angeles
Los Angeles, California, 90095 - 7370, United States
Esperanza Clinical
Murrieta, California, 92562, United States
Sutter Health
San Francisco, California, 94114, United States
Galiz Research
Hialeah, Florida, 33016, United States
UF College of Medicine - Jacksonville
Jacksonville, Florida, 32209, United States
K2 Medical Research
Lady Lake, Florida, 32159, United States
K2 Medical Research
Maitland, Florida, 32751, United States
ClinCloud Research
Melbourne, Florida, 32940, United States
Miami Jewish Health Systems
Miami, Florida, 33137, United States
The Roskamp Institute
Sarasota, Florida, 34243, United States
Charter Research
Winter Park, Florida, 32792, United States
Alzheimer's Disease Center
Braintree, Massachusetts, 02184, United States
Headlands Research
Plymouth, Massachusetts, 02360, United States
Be Well Clinical Studies
Lincoln, Nebraska, 68616, United States
Darthmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 07366, United States
Velocity Clinical Research
East Syracuse, New York, 13057, United States
Ichor Research
Syracuse, New York, 13219, United States
American Carolina Clinical Research LLC
Charlotte, North Carolina, 28273, United States
Insight Clinical Trials LLC
Beachwood, Ohio, 44131, United States
Valley Medical Research
Centerville, Ohio, 45459, United States
Baylor Research Institute
Dallas, Texas, 75231, United States
Sante Clinical Research
Kerrville, Texas, 78028, United States
Be Well Clinical Studies
Round Rock, Texas, 78681, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alireza Atri, MD, PhD
Banner Health
- STUDY DIRECTOR
Andrew Stephens, MD, PhD
Life Molecular Imaging
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2022
First Posted
December 8, 2022
Study Start
December 1, 2022
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
April 29, 2026
Record last verified: 2025-12