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

NCT ID: NCT01565382

Last Updated: 2022-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2011-02-28

Brief Summary

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).

Conditions

Alzheimer's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Independent, blinded reader trainees

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

Group Type: EXPERIMENTAL

florbetapir F 18

Intervention Type: DRUG

IV injection, 370MBq (10mCi), single dose (intervention for Study A05 participants, source of scans for this study)

Interventions

florbetapir F 18

IV injection, 370MBq (10mCi), single dose (intervention for Study A05 participants, source of scans for this study)

Intervention Type: DRUG

Other Intervention Names

18F-AV-45; Amyvid; florbetapir

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Avid Radiopharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chief Medical Officer

Role: STUDY_DIRECTOR

Avid Radiopharmaceuticals

Other Identifiers

18F-AV-45-A09

Identifier Type: -

Identifier Source: org_study_id