A Study of 18F-AV-45 in Alzheimer's Disease (AD) and Healthy Volunteers

Avid Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: florbetapir F 18

Study type: Interventional

Funder types: Industry

Identifiers

NCT01565343

18F-AV-45-A04

Details and patient eligibility

About

This study will test if two AV-45 PET scans up to 4 weeks apart in AD subjects and healthy volunteers provide the same results. The study will also test two different AV-45 injection methods in a small subgroup of enrolled AD subjects (slow vs. fast bolus group).

Enrollment: 25 patients

Sex: All

Ages: 35+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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 (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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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25 participants in 3 patient groups

AD Subjects

Experimental group

Description:

Two bolus IV injections followed by brain PET scan up to 4 weeks apart

Treatment:

Drug: florbetapir F 18

AD Subjects: Slow vs. Fast Bolus

Experimental group

Description:

Two bolus IV injections followed by a brain PET scan up to 4 weeks apart. The first injection given as a rapid bolus (\< 5 second injection, with immediate flush). The second injection given as a slow bolus (approximately 20 to 30 second injection with a flush delayed by 10 seconds after dose administration).

Treatment:

Drug: florbetapir F 18

Healthy controls

Experimental group

Description:

Healthy male or female subjects; 35-55 years old. Two bolus IV injections followed by brain PET scan up to 4 weeks apart

Treatment:

Drug: florbetapir F 18