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NCT04639050 · ClinicalTrials.gov registry record · Phase 1
Brainshuttle AD: A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7126209 Following Intravenous Infusion in Participants With Prodromal or Mild to Moderate Alzheimer's Disease
A Phase 1 study of Alzheimers Disease, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 1
- Development phase
- 241
- Enrollment target
- 20
- Study locations
NCT04639050: Active Phase 1 study of Alzheimers Disease, sponsored by Hoffmann-La Roche.
NCT04639050 is a Phase 1 study of Alzheimers Disease that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 241 participants, below the 3,925-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04639050, a Phase 1 study of Alzheimers Disease, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 241 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics of multiple-ascending intravenous (IV) doses of RO7126209 in participants with prodromal or mild to moderate Alzheimer's disease (AD), who are amyloid positive based on amyloid positron emission tomography (PET) scan.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG RO7126209
Study Locations (20)
Florida
- JEM Research LLC - Atlantis
- K2 Medical Research-Winter Garden - Clermont
- K2 Medical Research - The Villages - Lady Lake
- K2 Medical Research, LLC - Maitland
- Optimus U Corp - Miami
- Charter Research - Winter Park/Orlando - Orlando
- Advent Health Orlando - Orlando
- Alzheimer's Research and Treatment Center - Stuart
- Charter Research - Lady Lake/The Villages - The Villages
- Alzheimer?s Research and Treatment Center - Wellington
- Conquest Research, LLC - Winter Park
Georgia
- Alzheimer's Research and Treatment Center - Columbus - Columbus
- Center for Advanced Research & Education - Gainesville
Victoria
- Heidelberg Repatriation Hospital - Heidelberg West
- Alfred Hospital - Melbourne
Michigan
- Quest Research Institute - Farmington Hills
Oregon
- Summit Research Network Inc. - Portland
Pennsylvania
- Abington Neurological Associates - Abington
Texas
- Kerwin Research Center, LLC - Dallas
British Columbia
- Richmond Clinical Trials - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 241 participants |
| Start Date | 2021-03-15 |
| Est. Completion | 2030-06-30 |
| Phase | Phase 1 |
What the registry record for NCT04639050 still lists
NCT04639050 is an interventional study that assigns participants to a tested intervention. The registered 241 participants enrollment target is mid-sized for trials with a published cap, below the 3,925-participant average among 147 other Alzheimers Disease trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Alzheimers Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04639050 names 20 study sites across 8 states, led by Florida, Georgia, Victoria.
Frequently Asked Questions
What is clinical trial NCT04639050 about?
NCT04639050 is a clinical study titled "Brainshuttle AD: A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7126209 Following Intravenous Infusion in Participants With Prodromal or Mild to Moderate Alzheimer's Disease". The purpose of this study is to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics of multiple-ascending intravenous (IV) doses of RO7126209 in participants with prodromal or mild to moderate Alzheimer's disease (AD), who are amyloid positive based on amyloid p...
What is the current status of trial NCT04639050?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 241 participants. The study started on 2021-03-15. Estimated completion is 2030-06-30.
What conditions does trial NCT04639050 study?
This clinical trial studies the following conditions: Alzheimers Disease.
What interventions are being tested in trial NCT04639050?
The interventions under investigation include: Placebo (DRUG), RO7126209 (DRUG).
Who is sponsoring clinical trial NCT04639050?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04639050 being conducted?
This trial has 20 study locations across Florida, Georgia, Michigan, Oregon, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alzheimers 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 NCT04639050's enrollment target sits among peer trials
241 51st of 147 higher than 97 of 147 other Alzheimers Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimers 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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