Status:
COMPLETED
Brain Uptake and Safety With Probable Alzheimer's Disease, Amnestic Mild Cognitive Impairment and Healthy Volunteers
Lead Sponsor:
GE Healthcare
Collaborating Sponsors:
i3 Statprobe
Medpace, Inc.
Conditions:
Alzheimer's Disease
Amnestic Mild Cognitive Impairment
Eligibility:
All Genders
25+ years
Phase:
PHASE2
Brief Summary
Study to Assess Brain Uptake and Safety of AH110690 (18F) Injection in Subjects with Probable Alzheimer's Disease, Amnestic Mild Cognitive Impairment and Healthy Volunteers.
Eligibility Criteria
Inclusion
- The subject meets National Institute of Neurological and Communicative Disorders and Stroke; Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for clinically probable AD and Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for dementia of Alzheimer's type.
- The subject meets Petersen criteria for amnestic MCI.
- The subject has no evidence of cognitive impairment by medical history.
Exclusion
- The subject may not be able to complete the study as judged by the investigator.
- The subject has received ionising radiation exposure from clinical trials in the last 12 months or has participated in any other clinical study within 30 days of study entry.
- The subject has known allergies to \[18F\]AH110690 or \[11C\]PIB or their constituents.
- The subject is pregnant or breast-feeding.
- The subject has a history of alcohol and/or drug abuse within the last 2 years based upon a review of medical records.
- The subject has a contraindication for MRI (including, but not limited to, claustrophobia, pacemaker, presence of metallic fragments near the eyes or spinal cord, or cochlear implant).
- The subject has a history of head injury with loss of consciousness.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT00785759
Start Date
September 1 2008
End Date
December 1 2009
Last Update
December 7 2009
Active Locations (1)
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1
GE Healthcare
Oslo, Norway