N/A Completed N=151 Single-blind Diagnostic

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

Alzheimer's Disease · Mild Cognitive Impairment · Neurodegenerative diseases

Source: ClinicalTrials.gov NCT01550549 ↗

Enrolled (actual)

151

Serious AEs

—

Results posted

Jun 2012

Primary outcomePrimary: Inter-rater Reliability — 0.81 kappa statistic

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Inter-rater Reliability	0.81	—
SECONDARY Sensitivity of Florbetapir-PET to Detect Moderate to Frequent Beta-amyloid Neuritic Plaques (Probable/Definite Alzheimer's Disease)	79; 86; 92; 100; 69; 75	—
SECONDARY Specificity of Florbetapir-PET to Detect no or Sparse Beta-amyloid Neuritic Plaques (Probable/Definite Alzheimer's Disease)	90; 89; 90; 89; 95; 94	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01550549). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.