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New treatment option for Alzheimer Disease
Official title [18F]PI-2620 Phase 3 Histopathological Study
ClinicalTrials.gov ID: NCT05641688
What this study is testing
What is [18F]PI-2620?
[18F]PI-2620 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for alzheimer disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older
You may be able to join if
- Only people who meet all of the following criteria will be eligible for enrollment into the study:
- 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...
- Written informed consent obtained from the subject and/or the subject's legally authorized representative (LAR), as applicable, to consent for study...
- Can tolerate study procedures including lying down in PET scanner. The investigator will carefully assess each subject and use medical judgment to...
You likely can't join if
- people will be excluded from the enrollment if they:
- Are receiving aggressive treatment with life sustaining measures (e.g. receiving chemotherapy; palliative chemotherapy is allowed)
- Are known to have a structural brain lesion that would interfere either with PET imaging or pathological assessment (e.g. lesions are typically \> 2...
- Have suspected encephalopathy due to alcoholism or end-stage liver disease
- Are known to have a Glomerular Filtration Rate below \< 15 mL/min
- Have received an investigational or approved therapy directly targeting amyloid or tau
See the full eligibility criteria
- Only people who meet all of the following criteria will be eligible for enrollment into the study:
- 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...
- 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...
- 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
- people will be excluded from the enrollment if they:
- Are receiving aggressive treatment with life sustaining measures (e.g. receiving chemotherapy; palliative chemotherapy is allowed)
- 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...
- Have suspected encephalopathy due to alcoholism or end-stage liver disease
- Are known to have a Glomerular Filtration Rate below \< 15 mL/min
- Have received an investigational or approved therapy directly targeting amyloid or tau
- Are 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...
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Sun City, Arizona, United States
- Los Angeles, California, United States
- Murrieta, California, United States
- San Francisco, California, United States
- Hialeah, Florida, United States
- Jacksonville, Florida, United States
- Lady Lake, Florida, United States
- Maitland, Florida, United States
- Melbourne, Florida, United States
- Miami, Florida, United States
- Sarasota, Florida, United States
- Winter Park, Florida, United States
- Braintree, Massachusetts, United States
- Plymouth, Massachusetts, United States
- Lincoln, Nebraska, United States
- Lebanon, New Hampshire, United States
- East Syracuse, New York, United States
- Syracuse, New York, United States
- Charlotte, North Carolina, United States
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Sun City, Arizona, United States; Los Angeles, California, United States; Murrieta, California, United States; San Francisco, California, United States; Hialeah, Florida, United States and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.