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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: Recruiting Phase 1 study of Alzheimer Disease, sponsored by Washington University School of Medicine.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Amyloid positivity will be measured by either PET or CSF or blood-based biomarker (BBBM). Investigators will analyze the correlation between image quality and amyloid positivity to support any conclusions that will determine if 18F-MK6240 or 18F-RO948 has better discrimination between Amyloid + and Amyloid - subjects.
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 |
What NCT05464368 shows while recruiting
NCT05464368 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 2,751-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Alzheimer Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05464368's enrollment target sits among peer trials
38 234th of 306 higher than 72 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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