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Also known as florbetapir (18F)
florbetapir · 1 trial · 2 indications
Five readers blinded to all clinical information classified florbetapir-Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read was the primary efficacy endpoint for the qualitative evaluation.
Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.
| Arm | Type | Description |
|---|---|---|
| AD Subjects | EXPERIMENTAL | - |
| MCI | EXPERIMENTAL | MCI (mild cognitive impairment) |
| Healthy Controls | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| florbetapir (18F) | DRUG | IV injection, 370 MBq(10mCi), single dose |
Inclusion Criteria: Subjects who meet all of the following criteria are eligible to enroll in the arm of this trial reserved for subjects with AD: 1. Japanese males or females at least 50 years of age, with probable AD according to the NINCDS-ADRDA criteria (McKhann et al., 1984); 2. Subjects with...
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Florbetapir is a PET imaging agent being studied for use in Alzheimer's disease and mild cognitive impairment. It is designed to help visualize amyloid plaques in the brain during positron emission tomography scans. It is an investigational agent in clinical development and is not approved for commercial use.
Florbetapir is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. The company is the sponsor behind the clinical program evaluating the agent in neurology indications, specifically Alzheimer's disease and mild cognitive impairment.
Florbetapir is in Phase 2 clinical development. One Phase 2 trial has been completed, and no trials are currently active. Because the program remains investigational, florbetapir has not been established as an approved commercial product based on the available development information.
Florbetapir has been evaluated in one completed Phase 2 trial, NCT01662882, titled a Phase II trial of florbetapir (18F) PET imaging in Japan. The study enrolled 48 participants, including healthy volunteers, patients with mild cognitive impairment, and patients with Alzheimer's disease, and was conducted in Japan.
Yes, florbetapir and florbetapir (18F) refer to the same agent. The (18F) notation indicates the fluorine-18 radioisotope used in the compound for positron emission tomography imaging. Readers searching either name will find the same investigational PET imaging program developed by Eli Lilly and Company.
In Alzheimer's disease, florbetapir is being studied as a PET imaging agent to detect amyloid deposits in the brain. The completed Phase 2 trial NCT01662882 evaluated florbetapir (18F) PET imaging in healthy volunteers, patients with mild cognitive impairment, and patients with Alzheimer's disease in Japan, enrolling 48 participants.