Actively Recruiting
[18F]PI-2620 Phase 3 Histopathological Study
Led by Life Molecular Imaging Ltd · Updated on 2026-04-29
200
Participants Needed
25
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
[18F]PI-2620 Phase 3 Histopathological Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Receiving aggressive treatment with life sustaining measures (e.g. receiving chemotherapy; palliative chemotherapy is allowed)
- Known to have a structural brain lesion that would interfere either with PET imaging or pathological assessment (e.g. lesions typically > 2 cm including stroke, primary or metastatic neoplasm, other tumors or cystic lesions)
- History of major stroke or traumatic brain injury or other structural lesion; history of primary CNS neoplasm or known metastatic cancer must be discussed with the study sponsor prior to enrollment
- Suspected encephalopathy due to alcoholism or end-stage liver disease
- Known to have a Glomerular Filtration Rate below < 15 mL/min
- Received an investigational or approved therapy directly targeting amyloid or tau
- 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)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 25 locations
1
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
Actively Recruiting
2
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85352
Actively Recruiting
3
UC Los Angeles
Los Angeles, California, United States, 90095 - 7370
Actively Recruiting
4
Esperanza Clinical
Murrieta, California, United States, 92562
Actively Recruiting
5
Sutter Health
San Francisco, California, United States, 94114
Actively Recruiting
6
Galiz Research
Hialeah, Florida, United States, 33016
Actively Recruiting
7
UF College of Medicine - Jacksonville
Jacksonville, Florida, United States, 32209
Withdrawn
8
K2 Medical Research
Lady Lake, Florida, United States, 32159
Actively Recruiting
9
K2 Medical Research
Maitland, Florida, United States, 32751
Actively Recruiting
10
ClinCloud Research
Melbourne, Florida, United States, 32940
Actively Recruiting
11
Miami Jewish Health Systems
Miami, Florida, United States, 33137
Actively Recruiting
12
The Roskamp Institute
Sarasota, Florida, United States, 34243
Terminated
13
Charter Research
Winter Park, Florida, United States, 32792
Actively Recruiting
14
Alzheimer's Disease Center
Braintree, Massachusetts, United States, 02184
Actively Recruiting
15
Headlands Research
Plymouth, Massachusetts, United States, 02360
Withdrawn
16
Be Well Clinical Studies
Lincoln, Nebraska, United States, 68616
Withdrawn
17
Darthmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 07366
Actively Recruiting
18
Velocity Clinical Research
East Syracuse, New York, United States, 13057
Actively Recruiting
19
Ichor Research
Syracuse, New York, United States, 13219
Actively Recruiting
20
American Carolina Clinical Research LLC
Charlotte, North Carolina, United States, 28273
Terminated
21
Insight Clinical Trials LLC
Beachwood, Ohio, United States, 44131
Actively Recruiting
22
Valley Medical Research
Centerville, Ohio, United States, 45459
Actively Recruiting
23
Baylor Research Institute
Dallas, Texas, United States, 75231
Actively Recruiting
24
Sante Clinical Research
Kerrville, Texas, United States, 78028
Actively Recruiting
25
Be Well Clinical Studies
Round Rock, Texas, United States, 78681
Actively Recruiting
Research Team
A
Audrey Perrotin, PhD
CONTACT
A
Aleksandar Jovalekic, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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