Phase 3
N=218
Positron Emission Tomography (PET) Amyloid Imaging of the Brain in Healthy Young Adult Subjects
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01265394 ↗Enrolled (actual)
218
Serious AEs
0.0%
Results posted
Jun 2013
Primary outcome: Primary: Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid — 181; 0; 123; 58 Brain Scans Read
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- [18F] Flutemetamol (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- GE Healthcare
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid |
181; 0; 123; 58; 180; 1 | — |
| SECONDARY Measurement of Amyloid Content in Different Parts of the Brain |
1.12; 0.49 | — |
Summary
Amyloid is an abnormal chemical found in the brain of patients with Alzheimer's Disease (AD). The study drug helps produce pictures of amyloid in the brain. The purpose of this study is to determine how well the study drug performs in young healthy subjects.
Eligibility Criteria
Inclusion Criteria
- The subject age is 18 to 40 years.
- The subject has no evidence of thinking or memory problems by medical history.
- The subject has a normal MRI scan.
- The subject's general health is adequate to comply with study procedures.
- The subject is willing and able to participate in all study procedures.
Exclusion Criteria
- The subject has received any medical ionizing radiation exposure in the last 12 months (except planar x-ray or head CT).
- The subject has a contraindication for (cannot undergo) MRI.
- The subject has a history of head injury with loss of consciousness.
- The subject has any significant medical, psychiatric or neurological condition that might be associated with brain pathology.
- The subject has a family history of Alzheimer's Disease (AD); more than 1 first-degree relative.
Data sourced from ClinicalTrials.gov (NCT01265394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.