Evaluation of PET Scan Timing Relative to AV-45 Injection Time

Alzheimer's Disease Clinical Trial

Official title:

Comparison of PET Images Acquired at 30 Min and 50 Min Post Injection of 18F-AV-45 in Healthy Volunteers and Alzheimer's Disease Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01565356
• Other study ID #: 18F-AV-45-A06
• Status: Completed
• Phase: N/A
• First received: March 26, 2012
• Last updated: May 3, 2012
• Start date: March 2010
• Est. completion date: May 2010

Study information

• Verified date: May 2012
• Source: Avid Radiopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will re-read 10-minute positron emission tomography (PET) scans acquired in previous clinical studies of AV-45 at 30 and 50 minutes after injection and compare the results.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years and older

Eligibility

Eligibility for subjects scans to be used in this study is determined by subject's eligibility/enrollment in Study A01(NCT01565291) or A03(NCT01565330).

Inclusion Criteria (AD group):

• Greater than 50 years of age

• Probable AD according to the National Institute of Neurological and Communication Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria

• Mild/moderate dementia as evidenced by a Mini-Mental State Examination (MMSE) score ranging from 10 to 24, boundaries included, at screening

• History of cognitive decline gradual in onset and progressive over a period of at least 6 months

Inclusion Criteria (A01[NCT01565291] healthy volunteer group):

• 50 years of age, inclusive

• MMSE of 29 or greater

Inclusion Criteria (A03[NCT01565330] healthy volunteer group):

• 35 to 55 years of age, inclusive

• MMSE of 29 or greater

Exclusion Criteria (both groups):

• Neurodegenerative disorders other than AD, including, but not limited to Parkinson's disease, Pick's disease, fronto-temporal dementia, Huntington's chorea, Down syndrome, Creutzfeldt-Jacob disease, normal pressure hydrocephalus, and progressive supranuclear palsy

• Diagnosis of other dementing / neurodegenerative disease

• Diagnosis of mixed dementia

• Cognitive impairment resulting from trauma, hypoxic damage, vitamin deficiency, brain infection, brain cancer, endocrine disease, or mental retardation

• Clinically significant infarct or possible multi-infarct dementia as defined by the NINCDS criteria

• Evidence on screening MRI or other biomarker that suggests alternate etiology for cognitive deficit (for healthy controls, evidence suggesting the presence of AD pathology)

• Clinically significant psychiatric disease

• History of epilepsy or convulsions

• Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances

• Current clinically significant cardiovascular disease

• Received investigational medication within the last 30 days

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• florbetapir F 18
IV injection, 111 or 370MBq (3 or 10mCi), single dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Avid Radiopharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Qualitative Evaluation	Three independent readers blinded to subject identification, subject diagnosis, subject demographics and PET scan time points post-injection read each scan and reported as amyloid positive or amyloid negative. Results show the percentage of agreement between the majority read of 30-40 min scan and the majority read of the 50-60 min scan.	Scans acquired 30-40 min and 50-60 min after injection	No
Secondary	Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Semi-quantitative Evaluation	Three independent readers blinded to subject identification, subject diagnosis, subject demographics and PET scan time points post-injection read each scan and reported the results using a 5-point scale (0=no amyloid; 4=high levels of amyloid deposition). Results are reported as a weighted kappa statistic.	Scans acquired 30-40 min and 50-60 min post-injection	No