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

NCT01565356 | Completed Results

• 1 other identifier: 18F-AV-45-A06
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Alzheimer's Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Semi-quantitative Evaluation

  Scans acquired 30-40 min and 50-60 min post-injection

Interventions

florbetapir F 18 DRUG

IV injection, 111 or 370MBq (3 or 10mCi), single dose

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

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age, inclusive
• MMSE of 29 or greater
• to 55 years of age, inclusive
• MMSE of 29 or greater

You may not qualify if:

• 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

Sponsors & Collaborators

• Avid Radiopharmaceuticals: lead

MeSH Terms

Conditions

Alzheimer Disease

Interventions

florbetapir

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental 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 26, 2012
• First Posted: March 28, 2012
• Study Start: March 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: June 7, 2012
• Results First Posted: June 7, 2012

Record last verified: 2012-05