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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 an investigational small molecule being studied for use in Alzheimer's Disease. It is a positron emission tomography (PET) imaging agent that was evaluated in a Phase 2 clinical trial in Japan involving healthy volunteers, patients with mild cognitive impairment, and patients with Alzheimer's Disease.
Florbetapir is a PET imaging agent designed to bind to amyloid plaques in the brain, which are a hallmark of Alzheimer's Disease. By targeting these plaques, florbetapir is intended to enable visual detection of amyloid pathology through PET imaging, aiding in the evaluation of patients with cognitive impairment.
Florbetapir is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting clinical research on this imaging agent for potential use in Alzheimer's Disease.
Florbetapir is in Phase 2 clinical development. It is an investigational agent and has not been approved by regulatory authorities. The Phase 2 trial has been completed, and the drug remains under investigation for its potential use in Alzheimer's Disease imaging.
Florbetapir has one completed clinical trial, registered as NCT01662882. This Phase 2 study evaluated florbetapir (18F) PET imaging in Japan in healthy volunteers, patients with mild cognitive impairment, and patients with Alzheimer's Disease. The trial enrolled 48 participants and was a controlled study.
Florbetapir is also known as Amyvid, a brand name for the same compound. The drug is a radioactive diagnostic agent used with PET imaging to estimate amyloid neuritic plaque density in the brain. It is being developed by Eli Lilly and Company for use in Alzheimer's Disease evaluation.