Ability Of ([18F]-AV-45) PET Scan to Distinguish Alzheimer's Disease Subjects From Cognitively Normal Individuals
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|ClinicalTrials.gov Identifier: NCT00855868|
Recruitment Status : Completed
First Posted : March 5, 2009
Results First Posted : July 26, 2012
Last Update Posted : July 26, 2012
This study will evaluate the performance characteristics of a novel [18F] amyloid detection ligand (18F]-AV-45) with respect to its ability to distinguish patients with clinically-diagnosed probable Alzheimer's disease from cognitively normal elderly subjects and to independently compare its diagnostic performance characteristics with the ability of [11C]PIB to correctly categorize the same subjects.
- Individuals with a clinical diagnosis of probable Alzheimer's disease will have increased brain retention of [18F]-AV-45 compared to cognitively normal elderly individuals.
- There will be no clinically meaningful difference in the amyloid retention performance characteristics of [18F]-AV-45 and [l1C]PIB.
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: florbetapir F 18 Drug: [11C]-PIB||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Evaluation of the Ability of a Novel [18F] Amyloid Ligand ([18F]-AV-45) to Distinguish Patients With a Clinical Diagnosis of Alzheimer's Disease From Cognitively Normal Elderly Individuals|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
- Drug: florbetapir F 18
370 MBq (10 mCi), intravenous (IV) injection, single doseOther Names:
- Drug: [11C]-PIB
555 MBq (15 mCi), IV injection, single dose [11C]-PIBOther Name: C-11 PIB
- Differences in Standard Uptake Value Ratio (SUVR) for Frontal Cortex/Cerebellum and Whole Brain/Cerebellum of the Positron Emission Tomography (PET) Scan With [18F]-AV-45 for Probable Alzheimer's Disease (AD) Versus Cognitively Normal Subjects. [ Time Frame: 28 d ]Standardized Uptake Value ratio (SUVR) as measured in this study indicates the ratio of tracer uptake in the frontal cortex relative to the cerebellum or the ratio of tracer uptake in the whole brain relative to the cerebellum.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00855868
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Study Director:||Chief Medical Officer||Avid Radiopharmaceuticals|