RECRUITING

[18F]PI-2620 Phase 3 Histopathological Study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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)

Quick Facts

Study Start:2022-12-01

Study Completion:2026-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05641688

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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	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)

Inclusion Criteria

Exclusion Criteria

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

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)

Contacts and Locations

Study Contact

Audrey Perrotin, PhD

CONTACT

+49 (0)30 461 1246 03

clinicaltrials@life-mi.com

Aleksandar Jovalekic, PhD

CONTACT

+49 (0)30 461 1246 03

clinicaltrials@life-mi.com

Principal Investigator

Alireza Atri, MD, PhD

PRINCIPAL_INVESTIGATOR

Banner Health

Andrew Stephens, MD, PhD

STUDY_DIRECTOR

Life Molecular Imaging

Study Locations (Sites)

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

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

ClinCloud Research

Maitland, Florida, 32751

United States

K2 Medical Research

Maitland, Florida, 32751

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

Velocity Clinical Research

East Syracuse, New York, 13057

United States

American Carolina Clinical Research LLC

Charlotte, North Carolina, 28273

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

Collaborators and Investigators

Sponsor: Life Molecular Imaging Ltd

Alireza Atri, MD, PhD, PRINCIPAL_INVESTIGATOR, Banner Health
Andrew Stephens, MD, PhD, STUDY_DIRECTOR, Life Molecular Imaging

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-01

Study Completion Date2026-03

Study Record Updates

Study Start Date2022-12-01

Study Completion Date2026-03

Terms related to this study

Additional Relevant MeSH Terms

Alzheimer Disease