Back to resultsTo Compare Positron Emission Tomography (PET) Measurements of Fibrillar Amyloid Burden
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
[18F]AZD4694
Sponsored by
About this trial
This is an interventional diagnostic trial for Alzheimer's Disease focused on measuring PET, Alzheimer's disease, diagnostic
Eligibility Criteria
Inclusion Criteria:
- Male or female, of any race or/ethnicity
- ECG, vital signs, and clinical laboratory values are within normal limits at enrollment or deemed not clinically significant by the physician
Exclusion Criteria:
- Significant recent (within 6 months) history of neurological (including stroke) or psychiatric disorder or substance abuse
- Participated in a PET study within the last 12 months
- Pregnancy or lactation
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
[18F]4694
Outcomes
Primary Outcome Measures
PET Measurements
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00991419
Brief Title
To Compare Positron Emission Tomography (PET) Measurements of Fibrillar Amyloid Burden
Official Title
A Phase II, Open Label, Non-Randomized Study of [18F]AZD4694 to Compare PET Measurements of Fibrillar Amyloid Burden Obtained Using Difference Scanning Parameters, Reference Region Procedures and to Assess Test-retest Reliability in Patients With AD & HV
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare PET measurements of fibrillar amyloid burden using [18F]AZD4694.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
PET, Alzheimer's disease, diagnostic
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
[18F]4694
Intervention Type
Drug
Intervention Name(s)
[18F]AZD4694
Intervention Description
[18F]AZD4694 PET Ligand administered at Visit 1, 30 days following screening and at visit 4 for some of the participants.
Primary Outcome Measure Information:
Title
PET Measurements
Time Frame
Day 1 and Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female, of any race or/ethnicity
ECG, vital signs, and clinical laboratory values are within normal limits at enrollment or deemed not clinically significant by the physician
Exclusion Criteria:
Significant recent (within 6 months) history of neurological (including stroke) or psychiatric disorder or substance abuse
Participated in a PET study within the last 12 months
Pregnancy or lactation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric M Reiman, MD
Organizational Affiliation
Banner Alzheimer's Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
Country
United States
12. IPD Sharing Statement
Learn more about this trial
To Compare Positron Emission Tomography (PET) Measurements of Fibrillar Amyloid Burden
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