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[18F]PI-2620 Phase 3 Histopathological Study

NCT05641688 · Life Molecular Imaging SA
In plain English

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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)
About this study
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)
Study design
Enrollment target: 200 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-12-01
Estimated completion: 2027-06
Last updated: 2026-01-07
Interventions
Drug: [18F]PI-2620
Primary outcomes
  • 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) (At autopsy, until study completion with an average of 1 year)
Sponsor
Life Molecular Imaging Ltd · industry
Contacts & investigators
ContactAudrey Perrotin, PhD · contact · clinicaltrials@life-mi.com · +49 (0)30 461 1246 03
ContactAleksandar Jovalekic, PhD · contact · clinicaltrials@life-mi.com · +49 (0)30 461 1246 03
InvestigatorAlireza Atri, MD, PhD · principal_investigator, Banner Health
InvestigatorAndrew Stephens, MD, PhD · study_director, Life Molecular Imaging
All locations (25)
Barrow Neurological InstituteRecruiting
Phoenix, Arizona, United States
Banner Sun Health Research InstituteRecruiting
Sun City, Arizona, United States
UC Los AngelesRecruiting
Los Angeles, California, United States
Esperanza ClinicalRecruiting
Murrieta, California, United States
Sutter HealthRecruiting
San Francisco, California, United States
Galiz ResearchRecruiting
Hialeah, Florida, United States
UF College of Medicine - JacksonvilleRecruiting
Jacksonville, Florida, United States
K2 Medical ResearchRecruiting
Lady Lake, Florida, United States
K2 Medical ResearchRecruiting
Maitland, Florida, United States
ClinCloud ResearchRecruiting
Melbourne, Florida, United States
Miami Jewish Health SystemsRecruiting
Miami, Florida, United States
The Roskamp InstituteTerminated
Sarasota, Florida, United States
Charter ResearchRecruiting
Winter Park, Florida, United States
Alzheimer's Disease CenterRecruiting
Braintree, Massachusetts, United States
Headlands ResearchRecruiting
Plymouth, Massachusetts, United States
Be Well Clinical StudiesRecruiting
Lincoln, Nebraska, United States
Darthmouth-Hitchcock Medical CenterRecruiting
Lebanon, New Hampshire, United States
Velocity Clinical ResearchRecruiting
East Syracuse, New York, United States
Ichor ResearchRecruiting
Syracuse, New York, United States
American Carolina Clinical Research LLCTerminated
Charlotte, North Carolina, United States
Insight Clinical Trials LLCRecruiting
Beachwood, Ohio, United States
Valley Medical ResearchRecruiting
Centerville, Ohio, United States
Baylor Research InstituteRecruiting
Dallas, Texas, United States
Sante Clinical ResearchRecruiting
Kerrville, Texas, United States
Be Well Clinical StudiesRecruiting
Round Rock, Texas, United States
[18F]PI-2620 Phase 3 Histopathological Study · TrialPath