Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
200 participants
INTERVENTIONAL
2022-12-01
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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PI-2620 PET Scan
[18F]PI-2620
The radioligand, \[18F\]PI-2620, will be injected intravenously at a dose of 185 MBq ± 20%
Interventions
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[18F]PI-2620
The radioligand, \[18F\]PI-2620, will be injected intravenously at a dose of 185 MBq ± 20%
Eligibility Criteria
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Inclusion 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
Exclusion Criteria
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)
50 Years
ALL
No
Sponsors
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Life Molecular Imaging Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Alireza Atri, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Banner Health
Andrew Stephens, MD, PhD
Role: STUDY_DIRECTOR
Life Molecular Imaging
Locations
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Barrow Neurological Institute
Phoenix, Arizona, United States
Banner Sun Health Research Institute
Sun City, Arizona, United States
UC Los Angeles
Los Angeles, California, United States
Esperanza Clinical
Murrieta, California, United States
Sutter Health
San Francisco, California, United States
Galiz Research
Hialeah, Florida, United States
UF College of Medicine - Jacksonville
Jacksonville, Florida, United States
K2 Medical Research
Lady Lake, Florida, United States
K2 Medical Research
Maitland, Florida, United States
ClinCloud Research
Melbourne, Florida, United States
Miami Jewish Health Systems
Miami, Florida, United States
The Roskamp Institute
Sarasota, Florida, United States
Charter Research
Winter Park, Florida, United States
Alzheimer's Disease Center
Braintree, Massachusetts, United States
Headlands Research
Plymouth, Massachusetts, United States
Be Well Clinical Studies
Lincoln, Nebraska, United States
Darthmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Velocity Clinical Research
East Syracuse, New York, United States
Ichor Research
Syracuse, New York, United States
American Carolina Clinical Research LLC
Charlotte, North Carolina, United States
Insight Clinical Trials LLC
Beachwood, Ohio, United States
Valley Medical Research
Centerville, Ohio, United States
Baylor Research Institute
Dallas, Texas, United States
Sante Clinical Research
Kerrville, Texas, United States
Be Well Clinical Studies
Round Rock, Texas, United States
Countries
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Central Contacts
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Other Identifiers
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LMT-01-01-22
Identifier Type: -
Identifier Source: org_study_id
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