Evaluation of Web-based Training to Educate Physicians in the Methods of Interpreting Florbetapir-PET Scans

NCT01550549 | Completed Results

• 1 other identifier: 18F-AV-45-PT01
• Study Type: interventional
• Target: 151
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will investigate the performance of physician readers trained to read florbetapir-PET scans using electronic media training.

Conditions

Alzheimer Disease; Mild Cognitive Impairment; Neurodegenerative Diseases

Keywords

Amyloid imaging; Positron Emission Tomography; 18F-AV-45; florbetapir F 18; Diagnostic imaging

Outcome Measures

Primary Outcomes (1)

• Inter-rater Reliability

  Measure of agreement among five readers using a binary read method (amyloid positive/negative) calculated using Fleiss' kappa. All scans were read in a blinded fashion without access to clinical information.

  Scan acquired 50-60 min post-injection

Secondary Outcomes (2)

• Sensitivity of Florbetapir-PET to Detect Moderate to Frequent Beta-amyloid Neuritic Plaques (Probable/Definite Alzheimer's Disease)

  at autopsy, within 2 years of scan

• Specificity of Florbetapir-PET to Detect no or Sparse Beta-amyloid Neuritic Plaques (Probable/Definite Alzheimer's Disease)

  at autopsy, within 2 years of scan

Other Outcomes (1)

• Median Sensitivity and Specificity vs. CERAD Diagnosis

  Baseline scan

Interventions

florbetapir F 18 DRUG

No study drug will be administered in this study - scans previously acquired in in Study A05(NCT00702143) and A07(NCT00857415) will be read

Also known as: 18F-AV-45, Amyvid, florbetapir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Eligibility for subjects scans to be used in this study is determined by subject's eligibility/enrollment in Study A05 (NCT00702143) or A07 (NCT00857415). Alzheimer's disease (AD) group key eligibility criteria (from Study A05\[NCT00702143\]): * Male or female at least 50 years of age * Have probable AD per National Institute of Neurological and Communication Disorders and Stroke (NINCDS) criteria * Mini mental state exam (MMSE) score between 10 and 24 inclusive Mild cognitive impairment group key eligibility criteria (from Study A05\[NCT00702143): * Male or female at least 50 years of age * Complaints of memory or cognitive decline corroborated by an informant * Clinical dementia rating of 0.5 * No obvious cause for cognitive impairment (eg, head trauma or stroke) * Cognitive impairment onset within the past year * MMSE score greater than 24 Cognitively normal volunteer group key eligibility criteria (from Study A05\[NCT00702143\]): * Male or female at least 50 years of age * MMSE score greater than or equal to 29 and cognitively normal by informant report and psychometric test battery at screening Autopsy cohort key eligibility criteria (from Study A07\[NCT00857415\]): * Male or female 18 years or older * Projected life expectancy of less than 6 months * Consent to brain donation

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Avid Radiopharmaceuticals: lead

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Neurodegenerative Diseases

Interventions

florbetapir

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Avid Radiopharmaceuticals

clinicaloperations@avidrp.com

215-298-0700

Study Officials

• Chief Medical Officer

  Avid Radiopharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: March 12, 2012
• Study Start: August 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: June 7, 2012
• Results First Posted: June 7, 2012

Record last verified: 2012-05