No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
50 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Diagnostic
Participants needed
200 (estimated)
Sponsor
Lantheus Biosciences Ltd. · Industry
Who this trial is looking for
This trial is looking for people aged 50 and older with advanced Alzheimer’s disease. Participants will undergo a brain imaging test to see if it can effectively detect tau buildup compared to brain analysis after death.
Are You a Good Fit for This Trial?
You may be able to join if
I am 50 years old or older
I have a life expectancy of 1 year or less as determined by my doctor
I can give written consent or have a legal representative who can
I can tolerate lying down in a PET scanner
You may not be able to join if
I am receiving aggressive life-sustaining treatments like chemotherapy
I have a structural brain lesion that would interfere with imaging
I have suspected brain issues due to alcoholism or liver disease
My kidney function is below 15 mL/min
I have received treatment that targets amyloid or tau
I am pregnant, breastfeeding, or not using adequate contraception
I have specific implanted medical devices that are not safe for MRI
I have a history of claustrophobia if an MRI is planned
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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City
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Status
Eligibility Criteria
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 limit…
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)
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