Alzheimer DiseasePhase 3NCT05641688
[18F]PI-2620 Phase 3 Histopathological Study
A Phase 3 study testing [18F]PI-2620 in people with Alzheimer Disease, run by Lantheus Biosciences Ltd. at 25 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- [18F]PI-2620
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 25 sitesUnited States
- Study dates
- 1 Dec 2022to Sep 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Only subjects 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 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
Who cannot join
- Subjects 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 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)
- 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 not been certified for MRI, or history of claustrophobia in MRI (in case an MRI is planned to be performed)
Trial locations and contacts
25 sites in 1 country. Contact the study team or a site near you to ask about taking part.
25 sites in 1 country
United States25 sites, 17 recruiting
- Recruiting
Insight Clinical Trials LLC
Beachwood, Ohio, 44131
- Recruiting
Alzheimer's Disease Center
Braintree, Massachusetts, 02184
- Recruiting
Valley Medical Research
Centerville, Ohio, 45459
- Terminated
American Carolina Clinical Research LLC
Charlotte, North Carolina, 28273
- Recruiting
Baylor Research Institute
Dallas, Texas, 75231
- Terminated
Velocity Clinical Research
East Syracuse, New York, 13057
- Recruiting
Galiz Research
Hialeah, Florida, 33016
- Withdrawn
UF College of Medicine - Jacksonville
Jacksonville, Florida, 32209
- Recruiting
Sante Clinical Research
Kerrville, Texas, 78028
- Recruiting
K2 Medical Research
Lady Lake, Florida, 32159
- Terminated
Darthmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 07366
- Withdrawn
Be Well Clinical Studies
Lincoln, Nebraska, 68616
- Recruiting
UC Los Angeles
Los Angeles, California, 90095 - 7370
- Recruiting
K2 Medical Research
Maitland, Florida, 32751
- Recruiting
ClinCloud Research
Melbourne, Florida, 32940
- Recruiting
Miami Jewish Health Systems
Miami, Florida, 33137
- Recruiting
Esperanza Clinical
Murrieta, California, 92562
- Recruiting
Barrow Neurological Institute
Phoenix, Arizona, 85013
- Withdrawn
Headlands Research
Plymouth, Massachusetts, 02360
- Terminated
Be Well Clinical Studies
Round Rock, Texas, 78681
- Recruiting
Sutter Health
San Francisco, California, 94114
- Terminated
The Roskamp Institute
Sarasota, Florida, 34243
- Recruiting
Banner Sun Health Research Institute
Sun City, Arizona, 85352
- Recruiting
Ichor Research
Syracuse, New York, 13219
- Recruiting
Charter Research
Winter Park, Florida, 32792
About this study
Official title: An Open-label, Non-randomized, Multi-center Pivotal Phase 3 Study to Evaluate the Efficacy and Safety of PET Imaging With [18F]PI-2620 for the Detection of Tau Deposition When Compared to Post-mortem Histopathology (ADvance)
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
- Alzheimer Disease
- Being tested
- [18F]PI-2620
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]PI-2620Drug
The radioligand, [18F]PI-2620, will be injected intravenously at a dose of 185 MBq ± 20%
| Study group | Role | What they receive |
|---|---|---|
| PI-2620 PET Scan | Experimental | Not described Receives: Drug: [18F]PI-2620 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Efficacy of the visual assessment of [18F]PI-2620 PET imaging, in correctly differentiating tau neurofibrillary pathology associated with AD (NFT Score of B0 or B1 = negative)
[18F]PI-2620 PET scans will be classified as either tau-positive or tau-negative as defined by the reading methodology by each of the 5 independent readers blinded to the clinical and pathology information. NFT scores (as defined in Hyman et al. 2012) will be used as pathology assessment SoT (standard of truth). Tau neurofibrillary pathology associated with AD is defined as either negative with NFT Scores of B0 or B1 or positive NFT Scores of B2 or B3. The [18F]PI-2620 PET visual assessment will be compared with the pathology assessment to derive sensitivity and specificity estimates for each individual reader. Sensitivity and specificity are percentages that can range from 0 to 100%. The primary endpoint is considered to be met if for the same 3 out of 5 readers, the lower bound of the 95% CIs for both sensitivity and specificity are ≥ 50%.
Measured: At autopsy, until study completion with an average of 1 year
Secondary outcomes (4)
Diagnostic Efficacy of the visual assessment of [18F]PI-2620 PET imaging, in correctly differentiating tau neurofibrillary pathology associated with AD (NFT Score of B0, B1 or B2 = negative)
[18F]PI-2620 PET scans will be classified as either tau-positive or tau-negative as defined by the reading methodology by each of the 5 independent readers blinded to the clinical and pathology information. NFT scores (as defined in Hyman et al. 2012) will be used as pathology assessment SoT (standard of truth). Tau neurofibrillary pathology associated with AD is defined as either negative with NFT Scores of B0, B1 or B2 or positive NFT Scores of B3. The [18F]PI-2620 PET visual assessment will be compared with the pathology assessment to derive sensitivity and specificity estimates for each individual reader. Sensitivity and specificity are percentages that can range from 0 to 100%. The primary endpoint is considered to be met if for the same 3 out of 5 readers, the lower bound of the 95% CIs for both sensitivity and specificity are ≥ 50%.
Measured: At autopsy, until study completion with an average of 1 year
Diagnostic efficacy of the visual assessment of [18F]PI-2620 PET imaging, in correctly differentiating levels of AD neuropathologic change (ADNC) ('No' or 'Low' levels of ADNC = negative)
[18F]PI-2620 PET scans will be classified as either tau-positive or tau-negative as defined by the reading methodology by each of the 5 independent readers blinded to the clinical and pathology information. ADNC levels according to NIA-AA criteria (Hyman et al., 2012) will be used as pathology assessment SoT (standard of truth). Level of ADNC according to NIA-AA criteria (considering Braak stage, Thal plaque score, and CERAD amyloid neuritic plaque score) is defined as either negative with 'no' or 'low' ADNC levels or positive with 'intermediate' or 'high' ADNC levels. The [18F]PI-2620 PET visual assessment will be compared with the pathology assessment to derive sensitivity and specificity estimates for each individual reader. Sensitivity and specificity are percentages that can range from 0 to 100%. The primary endpoint is considered to be met if for the same 3 out of 5 readers, the lower bound of the 95% CIs for both sensitivity and specificity are ≥ 50%.
Measured: At autopsy, until study completion with an average of 1 year
Diagnostic efficacy of the visual assessment of [18F]PI-2620 PET imaging, in correctly differentiating levels of ADNC ('No', 'Low' or 'Intermediate" levels of ADNC = negative)
[18F]PI-2620 PET scans will be classified as either tau-positive or tau-negative as defined by the reading methodology by each of the 5 independent readers blinded to the clinical and pathology information. ADNC levels according to NIA-AA criteria (Hyman et al., 2012) will be used as pathology assessment SoT (standard of truth). Level of ADNC according to NIA-AA criteria (considering Braak stage, Thal plaque score, and CERAD amyloid neuritic plaque score) is defined as either negative with 'no', 'low' or 'intermediate' ADNC levels or positive with 'high' ADNC levels. The [18F]PI-2620 PET visual assessment will be compared with the pathology assessment to derive sensitivity and specificity estimates for each individual reader. Sensitivity and specificity are percentages that can range from 0 to 100%. The primary endpoint is considered to be met if for the same 3 out of 5 readers, the lower bound of the 95% CIs for both sensitivity and specificity are ≥ 50%.
Measured: At autopsy, until study completion with an average of 1 year
Inter-reader agreement for the visual assessment of [18F]PI-2620 PET images
Fleiss kappa will be used to measure the inter-reader agreement for the visual assessment of [18F]PI-2620 PET images.
Measured: Baseline scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start1 Dec 2022
- Primary completionMar 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lantheus Biosciences Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alireza Atri, MD, PhD, Principal investigator, Banner HealthAndrew Stephens, MD, PhD, Study director, Lantheus Germany GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641688
- Sponsor's protocol ID
- LMT-01-01-22
- Status last verified
- Oct 2026
- First submitted
- 17 Nov 2022
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Non-randomized, Multi-center Pivotal Phase 3 Study to Evaluate the Efficacy and Safety of PET Imaging With [18F]PI-2620 for the Detection of Tau Deposition When Compared to Post-mortem Histopathology (ADvance)
- ClinicalTrials.gov ID
- NCT05641688
- Acronym / sponsor ID
- LMT-01-01-22
- Conditions
- Alzheimer Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Lantheus Biosciences Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PI-2620 PET Scan | Experimental | Drug: [18F]PI-2620 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Only subjects 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 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
Key exclusion criteria (8 listed)
- 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 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)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]PI-2620The radioligand, [18F]PI-2620, will be injected intravenously at a dose of 185 MBq ± 20% | Drug | PI-2620 PET Scan |
Primary outcome
Diagnostic Efficacy of the visual assessment of [18F]PI-2620 PET imaging, in correctly differentiating tau neurofibrillary pathology associated with AD (NFT Score of B0 or B1 = negative)
Time frame: At autopsy, until study completion with an average of 1 year
[18F]PI-2620 PET scans will be classified as either tau-positive or tau-negative as defined by the reading methodology by each of the 5 independent readers blinded to the clinical and pathology information. NFT scores (as defined in Hyman et al. 2012) will be used as pathology assessment SoT (standard of truth). Tau neurofibrillary pathology associated with AD is defined as either negative with NFT Scores of B0 or B1 or positive NFT Scores of B2 or B3. The [18F]PI-2620 PET visual assessment will be compared with the pathology assessment to derive sensitivity and specificity estimates for each individual reader. Sensitivity and specificity are percentages that can range from 0 to 100%. The primary endpoint is considered to be met if for the same 3 out of 5 readers, the lower bound of the 95% CIs for both sensitivity and specificity are ≥ 50%.
4 secondary outcomes
Diagnostic Efficacy of the visual assessment of [18F]PI-2620 PET imaging, in correctly differentiating tau neurofibrillary pathology associated with AD (NFT Score of B0, B1 or B2 = negative)
Time frame: At autopsy, until study completion with an average of 1 year
Diagnostic efficacy of the visual assessment of [18F]PI-2620 PET imaging, in correctly differentiating levels of AD neuropathologic change (ADNC) ('No' or 'Low' levels of ADNC = negative)
Time frame: At autopsy, until study completion with an average of 1 year
Diagnostic efficacy of the visual assessment of [18F]PI-2620 PET imaging, in correctly differentiating levels of ADNC ('No', 'Low' or 'Intermediate" levels of ADNC = negative)
Time frame: At autopsy, until study completion with an average of 1 year
Inter-reader agreement for the visual assessment of [18F]PI-2620 PET images
Time frame: Baseline scan
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alireza Atri, MD, PhD principal investigator
Banner Health
Andrew Stephens, MD, PhD study director
Lantheus Germany GmbH
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing [18F]PI-2620 in people with Alzheimer Disease, run by Lantheus Biosciences Ltd. at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Audrey Perrotin, PhD (+49 (0)30 461 1246 03, clinicaltrials@lantheus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Efficacy of the visual assessment of [18F]PI-2620 PET imaging, in correctly differentiating tau neurofibrillary pathology associated with AD (NFT Score of B0 or B1 = negative) (time frame: At autopsy, until study completion with an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.