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NCT05464368 · ClinicalTrials.gov registry record · Phase 1
R21 Roche: 3-Way Tau Tracers in AD
A Phase 1 study of Alzheimer Disease, sponsored by Washington University School of Medicine.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT05464368 is a Phase 1 study of Alzheimer Disease that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 38 participants, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05464368, a Phase 1 study of Alzheimer Disease, is actively recruiting participants, sponsored by Washington University School of Medicine.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an open label study to compare three new generation TAU radioligands, 18F-RO948 (formerly known as 18F-6958948), 18F-MK6240, and \[18F\]GTP1for imaging of taupathy and demonstrate their absence of off-target binding in patients with Alzheimer disease (AD) and older healthy controls (OC). The study will directly compare AD and OC with these three next-generation TAU radioligands and compare each of them with historical data of the current most widely used first generation radioligand, 18F-AV1451. Upto38 (30 AD (Amyloid +)and 8 OC (Amyloid -), matched for age and sex with A+ subjects) male and female subjects aged 50-100 will be enrolled in this study protocol: up to 8 for Cohort 1, up to 8 for Cohort 2, and up to 22 for Cohort 3. The study consists of three cohorts: Cohort 1: Up to8 AD subjects (A+; CDR 0.5 and 1)will receive two PET scans in random order, with receiving either18F-RO948 or18F-MK6240 at the first scan. A third scan with 18F-GTP1is possible, depending on timing and radiotracer availability Cohort 2:Up to8 OC (A-; CDR=0)subjects will receive two PET scans in random order, with receiving either18F-RO948or 18F-MK6240 at the first scan. A third scan with 18F-GTP1is possible, depending on timing and radiotracer availability Cohort 3:Up to 22 (A+; CDR = 0, .5 and 1) subjects will receive three PET scans in random order, with receiving 18F-RO94818F-MK6240 or18F-GTP1at the first scan. Efforts will be made to include about 1/3 CDR = 0, 1/3 CDR .5, and 1/3 CDR 1 in Cohort 3.
Conditions Studied
Interventions
- DRUG 18F-MK6240
- DRUG [18F]RO-948
- DRUG 18F-GTP1
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2023-02-01 |
| Est. Completion | 2027-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05464368
The ClinicalTrials.gov registry entry for NCT05464368 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (99% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Alzheimer Disease appearing as the primary indexed condition, and to 3 interventions - of which 18F-MK6240 is the first listed.
NCT05464368 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT05464368 about?
NCT05464368 is a clinical study titled "R21 Roche: 3-Way Tau Tracers in AD". This is an open label study to compare three new generation TAU radioligands, 18F-RO948 (formerly known as 18F-6958948), 18F-MK6240, and \[18F\]GTP1for imaging of taupathy and demonstrate their absence of off-target binding in patients with Alzheimer disease (AD) and older healthy controls (OC). The...
What is the current status of trial NCT05464368?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2023-02-01. Estimated completion is 2027-06.
What conditions does trial NCT05464368 study?
This clinical trial studies the following conditions: Alzheimer Disease.
What interventions are being tested in trial NCT05464368?
The interventions under investigation include: 18F-MK6240 (DRUG), [18F]RO-948 (DRUG), 18F-GTP1 (DRUG).
Who is sponsoring clinical trial NCT05464368?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05464368 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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