NCT00785759CompletedPhase 2
An Open-label 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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- GE Healthcare
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Examine the efficacy and determine visual assessment of raised [18F] brain uptake for separating subjects with probable Alzheimer's Disease from healthy volunteers and assigning amnestic mild cognitive impairment cases to an AD or HV category.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Examine the efficacy and determine visual assessment of raised [18F] brain uptake for separating subjects with probable Alzheimer's Disease from healthy volunteers and assigning amnestic mild cognitive impairment cases to an AD or HV category.
Time Frame: September 2008 - February 2009
Secondary Outcomes
- Examine the efficacy and parameters of brain [18F] uptake for separating 25 subjects with probable AD from 25 HV, assigning 20 amnestic MCI cases to an AD or HV category by measuring ranges of regional cerebral to cerebellum tracer uptake ratios.(September 2008 - February 2009)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
A Study of the Safety and Tolerability of ASP0777 in Subjects With Alzheimer's Disease (AD) Taking a Stable Dose of DonepezilAlzheimer's DiseaseNCT01406145Astellas Pharma Inc60
Completed
Not Applicable
Observational Study to Monitor Long-term Immunogenicity and Efficacy of UB 311 Vaccine in Subjects With Alzheimer's DiseaseAlzheimer's DiseaseNCT01189084United Biomedical14
Terminated
Phase 4
Functional Brain Imaging of Medication Treatment Response in Mild Alzheimer's Disease PatientsAlzheimer's DiseaseNCT00369603Duke University4
Completed
Phase 1
Multi-centre Study of HTL0018318 in Patients as an add-on to Standard-of-careAlzheimer's DiseaseNCT03456349Heptares Therapeutics Limited60
Completed
Phase 2
A Study of the Safety and Tolerability of AZD5213 Effect on Sleep for Patients With Alzheimer's/Cognitive ImpairmentMild Cognitive ImpairmentMild Alzheimer's DiseaseNCT01548287AstraZeneca164