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PET Imaging Agent
[18F]PI-2620 PET Imaging for Alzheimer's Disease
Verified Trial
Phase 3
Recruiting
Led By Alireza Atri, MD, PhD
Research Sponsored by Life Molecular Imaging Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at autopsy, until study completion with an average of 1 year
Awards & highlights
Study Summary
This trial tests the accuracy of PET imaging to detect Alzheimer's disease in living patients, compared to post-mortem brain autopsies.
Who is the study for?
This trial is for men and women over 50 with Alzheimer's or terminal conditions like end-stage dementia, who are not on aggressive life-sustaining treatments, have a life expectancy of ≤1 year, can lie in a PET scanner, and consent to brain donation after death. Pregnant women or those without proper contraception are excluded.Check my eligibility
What is being tested?
[18F]PI-2620 is being tested for its ability to detect tau protein deposits in the brain using PET imaging. Participants will be compared with post-mortem histopathology results to assess the accuracy of this method in living subjects versus autopsy findings.See study design
What are the potential side effects?
Since [18F]PI-2620 is used for imaging rather than treatment, typical side effects associated with medications may not apply here. However, participants may experience discomfort from lying still during the PET scan or potential reactions related to the imaging process.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at autopsy, until study completion with an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at autopsy, until study completion with an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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)
Secondary outcome measures
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)
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)
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)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: PI-2620 PET ScanExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
[18F]PI-2620
2018
Completed Phase 2
~150
Find a Location
Who is running the clinical trial?
Life Molecular Imaging LtdLead Sponsor
Alireza Atri, MD, PhDPrincipal InvestigatorBanner Health
Andrew Stephens, MD, PhDStudy DirectorLife Molecular Imaging
4 Previous Clinical Trials
255 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I might have brain issues due to heavy drinking or severe liver disease.I have given my written consent for study procedures and brain donation.I am a woman who could get pregnant and am not using birth control, or I am pregnant or breastfeeding.I am 50 years old or older.I am currently undergoing chemotherapy for my condition.I have been treated with a drug for amyloid or tau.I do not have large brain lesions or a history of major brain issues that could affect imaging tests.
Research Study Groups:
This trial has the following groups:- Group 1: PI-2620 PET Scan
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this investigation ongoing?
"Based on the information found at clinicaltrials.gov, this specific trial is no longer recruiting participants. After first being posted in December of 2022 it was last updated five days later with 555 other trials actively looking for candidates presently."
Answered by AI
What potential hazards are associated with PI-2620 PET Scans?
"Through rigorous testing, PI-2620 PET Scan has been evaluated to be of a high level of safety as indicated by its score of 3 on Power's scale. This is due to existing evidence that suggests efficacy and multiple tests confirming safety."
Answered by AI
Who else is applying?
What site did they apply to?
Headlands Research
What portion of applicants met pre-screening criteria?
Did not meet criteria
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