- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00991419
To Compare Positron Emission Tomography (PET) Measurements of Fibrillar Amyloid Burden
January 29, 2013 updated by: AstraZeneca
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
The purpose of this study is to compare PET measurements of fibrillar amyloid burden using [18F]AZD4694.
Study Overview
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
[18F]4694
|
[18F]AZD4694 PET Ligand administered at Visit 1, 30 days following screening and at visit 4 for some of the participants.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
PET Measurements
Time Frame: Day 1 and Day 7
|
Day 1 and Day 7
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eric M Reiman, MD, Banner Alzheimer's Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
October 7, 2009
First Submitted That Met QC Criteria
October 7, 2009
First Posted (Estimate)
October 8, 2009
Study Record Updates
Last Update Posted (Estimate)
January 30, 2013
Last Update Submitted That Met QC Criteria
January 29, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D2750N00006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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