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Also known as F-18 FEDAA1106 (BAY85-8101)
F-18 FEDAA1106 · 2 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | EXPERIMENTAL | - |
| Arm 3 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| F-18 FEDAA1106 (BAY85-8101) | DRUG | MS/CIS patients: Single intravenous bolus of 140 MBq BAY85-8101 ± 15% (ca. 5 mSv), applied mass of tracer \< 5 µg, PET |
Inclusion Criteria: Healthy volunteers for brain imaging: * males or females, age 20 - 55 years * assessment of the brain MRI as "normal (age-appropriate)" * absence of any sign of CNS disease, no co-medi cation Patients for brain imaging * males or females, age 20 - 55 years * patients with previ...
F-18 FEDAA1106 is an investigational positron emission tomography (PET) imaging agent developed by Bayer AG. It is a small molecule radiotracer studied for use in neurology, specifically to support PET imaging in conditions such as Alzheimer's disease and multiple sclerosis. It remains in Phase 1 clinical development.
F-18 FEDAA1106 is being studied as a PET imaging tracer in neurology. Phase 1 trials have evaluated it in positron-emission tomography in people with probable Alzheimer's disease, in patients with multiple sclerosis, and in healthy volunteers, including radiation dosimetry assessment in healthy participants.
F-18 FEDAA1106 is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer sponsored the Phase 1 PET tracer studies of the compound.
F-18 FEDAA1106 is in Phase 1 development. Both of its recorded clinical trials are Phase 1 studies and both are completed, with no active trials ongoing. It is an investigational imaging agent and is not an approved product.
Two completed Phase 1 trials are registered for F-18 FEDAA1106. NCT01035164 evaluated the tracer in probable Alzheimer's disease patients versus healthy volunteers and assessed radiation dosimetry, enrolling 25 participants in the Netherlands and Sweden. NCT01031199 compared the PET tracer in multiple sclerosis patients and healthy volunteers, enrolling 16 participants in Australia and Sweden.
Yes. F-18 FEDAA1106 is also known as BAY85-8101, and the compound has additionally been referred to as ZK 6032924 in its clinical trial records. These names refer to the same Bayer PET imaging agent.