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A Phase II Trial of Florbetapir (18F) Positron Emission Tomography (PET) Imaging in Japan of Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)

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ClinicalTrials.gov Identifier: NCT01662882
Recruitment Status : Completed
First Posted : August 13, 2012
Results First Posted : September 19, 2013
Last Update Posted : September 19, 2013
Eli Lilly and Company
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions: Alzheimer's Disease
Mild Cognitive Impairment
Intervention: Drug: florbetapir (18F)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
AD Subjects florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
Healthy Controls florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
MCI Subjects

MCI (mild cognitive impairment)

florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose

Participant Flow:   Overall Study
    AD Subjects   Healthy Controls   MCI Subjects
STARTED   15   18   15 
COMPLETED   15   18   15 
NOT COMPLETED   0   0   0 

  Baseline Characteristics

  Outcome Measures

1.  Primary:   Qualitative Amyloid Image Assessment   [ Time Frame: 50-60 min after injection ]

2.  Primary:   Mean Cortical to Cerebellum SUVR   [ Time Frame: 50-60 min after injection ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information