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MRI, FDG-PET · 1 trial · 1 indication
Part I: regional cerebral blood flow, measured by dASL at Baseline and 1 week in AD participants and cognitively normal controls. Part II: regional cerebral blood flow, measured at 6 months and 12 months in AD participants and normal control participants.
| Arm | Type | Description |
|---|---|---|
| AD Participants | EXPERIMENTAL | Participants with a diagnosis of mild-to-moderate AD |
| Cognitively Normal Elderly Participants | EXPERIMENTAL | Elderly participants with no cognitive impairment |
| Name | Type | Description |
|---|---|---|
| MRI | OTHER | During the study all participants will have 4 total MRI scans: baseline, 1 week, 6 and 12 months. |
| FDG-PET | OTHER | 2 to 4 PET scans will be done over 12 months, 2 planned and 2 more if data from any of these are un-interpretable |
Inclusion Criteria: The prospective participant must meet, at least, all of the criteria below (among others determined by the study staff) to be eligible for study participation. The participant: * Has mild-to-moderate Alzheimer's Disease (AD), OR is considered cognitively normal; * Has been on ...
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MRI, FDG-PET is an investigational imaging approach being studied for use in Alzheimer's Disease. It was evaluated in a Phase 1 clinical trial as a potential biomarker to assess regional cerebral blood flow compared to positron emission tomography in patients with mild-to-moderate Alzheimer's Disease and cognitively normal elderly subjects.
MRI, FDG-PET is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company sponsored a Phase 1 clinical trial of this imaging approach in Alzheimer's Disease.
MRI, FDG-PET is in Phase 1 clinical development. It has completed one Phase 1 trial in Alzheimer's Disease, and it remains an investigational imaging approach that is not approved for clinical use.
MRI, FDG-PET has been studied in one completed Phase 1 clinical trial, NCT00757939. This trial assessed regional cerebral blood flow as an Alzheimer's Disease biomarker compared to positron emission tomography in patients with mild-to-moderate Alzheimer's Disease and cognitively normal elderly subjects, enrolling 40 participants.
MRI, FDG-PET is not FDA approved. It is an investigational imaging approach that has completed a Phase 1 clinical trial in Alzheimer's Disease, but it remains in clinical development and has not been approved for any use.