Evaluation of Inter-reader Reliability Using Images From Subjects With Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI)

Avid Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Alzheimer's Disease

Treatments: Drug: florbetapir F 18

Study type: Interventional

Funder types: Industry

Identifiers

NCT01565382

18F-AV-45-A09

Details and patient eligibility

About

Re-read of brain amyloid scans acquired in previous AV-45 clinical studies by readers trained using updated reading methodology. The scans in this study came from subjects who had Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI).

Enrollment: 40 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Participants:

• Inclusion Criteria AD:

  • Male or female >=50 years of age
  • Meet National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) criteria for probable AD with Mini-Mental State Examination (MMSE) score of 10-24

• Inclusion Criteria MCI:

  • Male or female >=50 years of age
  • Have a Clinical Dementia Rating (CDR) of 0.5
  • MMSE >24

• Exclusion Criteria:

  • Have a history or current diagnosis of other neurologic disease
  • Have had or currently have a diagnosis of other neurodegenerative disease
  • Have participated in experimental therapy targeted to amyloid plaque

Readers:

•Private nuclear medicine physicians with no prior training in reading florbetapir-PET scans

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

---

40 participants in 1 patient group

Independent, blinded reader trainees

Experimental group

Description:

Seven practicing nuclear medicine physicians with no prior training in reading scans from florbetapir-PET, or other amyloid imaging agents.

Treatment:

Drug: florbetapir F 18