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NCT05641688PHASE3Recruiting

[18F]PI-2620 Phase 3 Histopathological Study

Lantheus Biosciences Ltd.

Start Date

12/1/2022

Completion Date

6/1/2027

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

Age Range: 50 years to No maximum

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)

Interventions

DRUG

[18F]PI-2620

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Conditions

Alzheimer Disease

Locations

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