PI-2620 PET Scan for Alzheimer's Disease

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Galiz Research, Hialeah, FLAlzheimer's Disease[18F]PI-2620 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial tests the accuracy of PET imaging to detect Alzheimer's disease in living patients, compared to post-mortem brain autopsies.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Similar Trials

1
[18F]RP-115 PET/MRI
1
AV-1959D 500 μg
1
[F-18]AV-1451-PET

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: At autopsy, until study completion with an average of 1 year

Year 1
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)
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)
Baseline scan
Inter-reader agreement for the visual assessment of [18F]PI-2620 PET images

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
[18F]RP-115 PET/MRI
1
AV-1959D 500 μg
1
[F-18]AV-1451-PET

Trial Design

1 Treatment Group

PI-2620 PET Scan
1 of 1

Experimental Treatment

200 Total Participants · 1 Treatment Group

Primary Treatment: PI-2620 PET Scan · No Placebo Group · Phase 3

PI-2620 PET Scan
Drug
Experimental Group · 1 Intervention: [18F]PI-2620 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
[18F]PI-2620
2018
Completed Early Phase 1
~20

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at autopsy, until study completion with an average of 1 year

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

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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