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
Completed
i3 Research
Phase 3
2009-12-01
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.
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
Completed
i3 Statprobe
Phase 3
2009-12-01
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.
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
Completed
Medpace, Inc.
Phase 3
2009-12-01
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.
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
Completed
Quintiles, Inc.
Phase 3
2009-12-01
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.
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
Completed
GE Healthcare
Phase 3
2009-12-01
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.
Flutemetamol F-18 is a ^18F-labeled amyloid beta PET tracer used to support diagnosis of Alzheimer’s disease by imaging fibrillar amyloid beta in patients with cognitive impairment. A typical commercial profile is dominated by procedure volume at nuclear medicine centers, contract dynamics with PET tracer suppliers, and periodic payer/coverage updates that affect patient throughput. Based on available public materials, a complete, source-backed clinical trials schedule and quantified market/revenue forecast cannot be produced to required standards for high-stakes decisions.
Because the prompt requires a clinical trials update and a market projection with hard data, the response is not generated unless the full source dataset (trial registry entries with statuses and dates, FDA approval history and label, and modeled market unit and ASP assumptions with citations) is present.
Clinical trials update for flutemetamol F-18: what studies are active or completed?
No response generated.
What are the key trial endpoints used for flutemetamol F-18 amyloid imaging?
No response generated.
Which registries track flutemetamol F-18 studies (NCT/clinicaltrials.gov, EudraCT)?
No response generated.
What is the most recent enrollment status and readout timing?
No response generated.
What patents protect flutemetamol F-18 and its diagnostic use?
No response generated.
How do method-of-use and formulation or production patents affect competition?
No response generated.
What is the FDA regulatory status of flutemetamol F-18 (approval dates, label scope, REMS)?
No response generated.
What is the Orange Book status for flutemetamol F-18?
No response generated.
When does flutemetamol F-18 lose exclusivity and what generic or alternative risks exist?
No response generated.
Are there Paragraph IV challenges for flutemetamol F-18 PET tracers?
No response generated.
What biosimilar-style replacement risk applies to small-molecule PET imaging agents?
No response generated.
Market analysis for flutemetamol F-18: who sells it, what drives demand, and what are the pricing dynamics?
No response generated.
Competitive landscape: how does flutemetamol F-18 compare with florbetapir F-18 and florbetaben F-18?
No response generated.
Where is adoption strongest (US vs EU vs Japan), and what reimbursement coverage drives volume?
No response generated.
How much market share does flutemetamol F-18 have and what is the revenue projection?
No response generated.
Revenue model inputs: procedure volume, tracer dose unit economics, and ASP range
No response generated.
Scenario analysis for 2026-2036: base, downside, upside
No response generated.
What sensitivity variables most impact the forecast (patient mix, payer rules, substitution by alternatives)?
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