Study Summary
This trial will compare tau PET scans from patients with FTLD, patients with naAD, and cognitively normal seniors to see if there are differences.
Eligible Conditions
- Frontotemporal Dementia
- Alzheimer's Disease
- Cognitively Normal
Treatment Effectiveness
Phase-Based Effectiveness
Phase 3
Study Objectives
2 Primary · 0 Secondary · Reporting Duration: Once during single PET CT
Once during single PET CT
Regional brain SUVR
Whole brain SUVR
Trial Safety
Phase-Based Safety
This is further along than 85% of similar trials
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
6 Treatment Groups
Cognitively and neurologically normal seniors (CN)
1 of 6
Non-amnestic Alzheimer's Disease (AD)
1 of 6
Frontotemporal lobar degeneration from tauopathy (FLTD-tau)
1 of 6
Frontotemporal lobar degeneration from TDP-43 (FLTD-TDP)
1 of 6
Frontotemporal lobar degeneration from mutation in the MAPT gene (genetic FLTD-t...
1 of 6
Frontotemporal lobar degeneration from mutation in the GRN gene or frame 72 of c...
1 of 6
Experimental Treatment
54 Total Participants · 6 Treatment Groups
Primary Treatment: [18F]PI-2620 · No Placebo Group · Phase 3
Cognitively and neurologically normal seniors (CN)Experimental Group · 2 Interventions: [18F]PI-2620, FPI-2620 · Intervention Types: Drug, Drug
Non-amnestic Alzheimer's Disease (AD)Experimental Group · 2 Interventions: [18F]PI-2620, FPI-2620 · Intervention Types: Drug, Drug
Frontotemporal lobar degeneration from tauopathy (FLTD-tau)Experimental Group · 2 Interventions: [18F]PI-2620, FPI-2620 · Intervention Types: Drug, Drug
Frontotemporal lobar degeneration from TDP-43 (FLTD-TDP)Experimental Group · 2 Interventions: [18F]PI-2620, FPI-2620 · Intervention Types: Drug, Drug
Frontotemporal lobar degeneration from mutation in the MAPT gene (genetic FLTD-tau)Experimental Group · 2 Interventions: [18F]PI-2620, FPI-2620 · Intervention Types: Drug, Drug
Frontotemporal lobar degeneration from mutation in the GRN gene or frame 72 of chromosome 9Experimental Group · 2 Interventions: [18F]PI-2620, FPI-2620 · Intervention Types: Drug, 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: once during single pet ct
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
1,899 Previous Clinical Trials
41,218,039 Total Patients Enrolled
10 Trials studying Frontotemporal Dementia
2,563 Patients Enrolled for Frontotemporal Dementia
National Institutes of Health (NIH)NIH
2,552 Previous Clinical Trials
24,612,667 Total Patients Enrolled
10 Trials studying Frontotemporal Dementia
3,803 Patients Enrolled for Frontotemporal Dementia
Jeffrey S PhillipsPrincipal InvestigatorUniversity of Pennsylvania
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:If you are a female, you have gone through menopause or had surgery that prevents you from having children.
A specialized doctor has diagnosed you with specific types of brain conditions called lvPPA or PCA.
Group 2: Alzheimer's disease without memory loss (naAD, n=12).
You are 45 years old or older and currently enrolled in the UNICORN study (IRB #842873).
Group 1 includes 12 seniors who have no problems with memory or thinking and have normal neurological function.
You are a man or woman who is at least 45 years old and participating in the UNICORN study. If you are a woman, you cannot become pregnant due to menopause or surgery.
You must have normal cognitive and neurological functioning, determined by a test like the MMSE or MoCA, or by evaluation from a trained clinician. You must also not have a history of depression, confirmed by a test like the Geriatric Depression scale or evaluation from a clinician. Additionally, you cannot have a family history of early-onset neurodegenerative disease.
You have been evaluated for depression and scored 6 or lower on the Geriatric Depression scale within the past 6 months, or a trained clinician has evaluated you. You must also have someone who can accompany you to all screening and study activities.
This study is looking for 12 people with a specific type of brain disease called FTLD-tau.
You have been diagnosed by a neurologist with a specific type of dementia called PSP, naPPA, or bvFTD that is consistent with Pick's disease.
Frequently Asked Questions
Are there any patients still needed for this research project?
"Active recruitment is underway for this study, which was originally posted on September 19th, 2020. The last update to the listing was made on October 12th, 2020." - Anonymous Online Contributor
Unverified Answer
How many candidates are being offered the chance to participate in this research?
"Yes, the information on clinicaltrials.gov point out that this trial is presently recruiting candidates. The study was originally posted on 9/19/2022 and was last edited on 10/12/2022. The clinical trial is enrolling 54 patients at 1 locations" - Anonymous Online Contributor
Unverified Answer
Will [18F]PI-2620 have any negative effects on patients?
"[18F]PI-2620 falls into the category of being a Phase 3 trial medication, which means that while there is some efficacy data, there is also multiple rounds of safety data. Consequently, our team at Power estimates the safety to be a 3." - Anonymous Online Contributor
Unverified Answer