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

NCT ID: NCT01565356

Last Updated: 2012-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2010-05-31

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

Study Design

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

Interventions

florbetapir F 18

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

Intervention Type: DRUG

Other Intervention Names

18F-AV-45; Amyvid; florbetapir

Eligibility Criteria

Inclusion Criteria

• 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

• 50 years of age, inclusive

• MMSE of 29 or greater

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

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-A06

Identifier Type: -

Identifier Source: org_study_id