At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 365 enrolled
Drug / intervention
Flutemetamol (18F) Injectiondrug
Likely dose
Flutemetamol (18F) Injection 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Principal Open-label Study to Assess the Prognostic Usefulness of Flutemetamol (18F) Injection for Identifying Subjects With Amnestic Mild Cognitive Impairment Who Will Convert to Clinically Probable Alzheimer's Disease
In Brief
A Phase 3 clinical trial evaluating Flutemetamol (18F) Injection for Mild Cognitive Impairment and Alzheimer's Disease. Completed, enrolled 365 participants across 1 site.
Detailed Summary
This study will investigate the efficacy of the Flutemetamol (18F) Injection PET tracer in identifying abnormal (18F) flutemetamol uptake patterns which predict the conversion from aMCI to a b-amyloid associated clinically probable Alzheimer's disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMild Cognitive Impairment, Alzheimer's Disease
CountriesUnited States
CollaboratorsMedpace, Inc., i3 Statprobe, i3 Research, Quintiles, Inc.
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2009
First PostedDec 2009
Primary CompletionJan 2014
TodayJul 2026
First PostedDec 9, 2009
Enrollment StartDec 1, 2009
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 16.6 years ago
Interventions
Flutemetamol (18F) Injectiondrug
All subjects will receive an i.v. dose of (18F) flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of (18F) flutemetamol will be 185 MBq.