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

Avid Pharmaceuticals

Status

Completed

Conditions

Alzheimer's Disease

Treatments

Drug: florbetapir F 18

Study type

Interventional

Funder types

Industry

Identifiers

NCT01565356

18F-AV-45-A06

Details and patient eligibility

About

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.

Enrollment

41 patients

Sex

All

Ages

35+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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