Ability Of ([18F]-AV-45) PET Scan to Distinguish Alzheimer's Disease Subjects From Cognitively Normal Individuals
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
florbetapir F 18
[11C]-PIB
Sponsored by
About this trial
This is an interventional diagnostic trial for Alzheimer's Disease focused on measuring Amyloid imaging, Positron Emission Tomography, 18F-AV-45, florbetapir F 18, Diagnostic imaging
Eligibility Criteria
Inclusion Criteria:
- Normal subjects: mini-mental state examination (MMSE) 27-30, clinical dementia rating (CDR) = 0, no symptoms of depression
- Alzheimer's subjects: MMSE 18-26, CDR >=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI
Exclusion Criteria:
- other neurological disease
- evidence of MRI abnormality
- psychiatric disorder
- alcohol abuse
- clinically significant lab abnormalities
- residence in nursing facility
- participation in clinical trial with experimental medication in past 1 month
Sites / Locations
- Research Site
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00855868
First Posted
March 2, 2009
Last Updated
June 19, 2012
Sponsor
Avid Radiopharmaceuticals
Collaborators
American College of Radiology Imaging Network, General Electric
1. Study Identification
Unique Protocol Identification Number
NCT00855868
Brief Title
Ability Of ([18F]-AV-45) PET Scan to Distinguish Alzheimer's Disease Subjects From Cognitively Normal Individuals
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 Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avid Radiopharmaceuticals
Collaborators
American College of Radiology Imaging Network, General Electric
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
SPECIFIC HYPOTHESES
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.
Detailed Description
15 patients with a clinical diagnosis of probable Alzheimer's disease and 15 cognitively normal elderly control subjects will receive both [18F]-AV-45 and [11C]PIB to compare the diagnostic performance characteristics of each amyloid ligand to distinguish AD from normal subjects. In addition to clinical diagnostic category, ligand retention will be evaluated with respect to measures of symptom severity and cerebrospinal fluid levels of amyloid and tau.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Amyloid imaging, Positron Emission Tomography, 18F-AV-45, florbetapir F 18, Diagnostic imaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
florbetapir F 18
Other Intervention Name(s)
18F-AV-45, Amyvid, florbetapir
Intervention Description
370 MBq (10 mCi), intravenous (IV) injection, single dose
Intervention Type
Drug
Intervention Name(s)
[11C]-PIB
Other Intervention Name(s)
C-11 PIB
Intervention Description
555 MBq (15 mCi), IV injection, single dose [11C]-PIB
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
28 d
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Normal subjects: mini-mental state examination (MMSE) 27-30, clinical dementia rating (CDR) = 0, no symptoms of depression
Alzheimer's subjects: MMSE 18-26, CDR >=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI
Exclusion Criteria:
other neurological disease
evidence of MRI abnormality
psychiatric disorder
alcohol abuse
clinically significant lab abnormalities
residence in nursing facility
participation in clinical trial with experimental medication in past 1 month
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Medical Officer
Organizational Affiliation
Avid Radiopharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Ability Of ([18F]-AV-45) PET Scan to Distinguish Alzheimer's Disease Subjects From Cognitively Normal Individuals
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