A Preliminary Study of 18F-AV-45 in Alzheimer's Disease and Healthy Elderly Volunteers

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

A preliminary study to test how florbetapir F 18 (18F-AV-45) acts in the brains and bodies of healthy elderly people and patients with Alzheimer's Disease (AD) by using a positron emission tomography (PET) scanner.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Avid Radiopharmaceuticals

Criteria

Inclusion Criteria (AD group):

• 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 exam (MMSE) score ranging from 10 to 24, boundaries included, at screening

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

Inclusion Criteria (healthy volunteer group):

• No evidence of significant cognitive impairment by history and psychometric testing

• MMSE of 29 or higher

Exclusion Criteria (both groups):

• Neurodegenerative disorders other than AD

• 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