Alzheimer Disease study: [18F]PI-2620
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 IV infusion (through 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 testing whether a special brain scan can find Alzheimer's changes. It compares the scan results to brain tissue checked after death.
- Who it's for
- You may be able to join if you have Alzheimer's disease or if you are a healthy control.
- What's involved
- You would get a brain scan while alive. After you pass away, your brain is checked to see if the scan was right.
- Time commitment
- The study lasts until after your death and a brain check.
- 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
- 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
- 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.
- 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
See the full eligibility criteria
- 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
- 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.
- 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 is enrolling
- 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
- Lady Lake, Florida, United States
- Maitland, Florida, United States
- Melbourne, Florida, United States
- Miami, Florida, United States
- Winter Park, Florida, United States
- Braintree, Massachusetts, United States
- Syracuse, New York, United States
- Beachwood, Ohio, United States
- Centerville, Ohio, United States
- Dallas, Texas, United States
- Kerrville, Texas, United States
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, but 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?
This study is enrolling now at 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 11 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.