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

Avid Pharmaceuticals

Status and phase: Completed; Early Phase 1

Conditions: Alzheimer Disease

Treatments: Drug: florbetapir F 18

Study type: Interventional

Funder types: Industry

Identifiers

NCT01565291

18F-AV-45-A01

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Subjects With AD

Experimental group

Description:

Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination (MMSE) from 10 to 24)

Treatment:

Drug: florbetapir F 18

Healthy Elderly Subjects

Experimental group

Description:

Cognitively normal with MMSE of 29 or higher; age 50 years or older

Treatment:

Drug: florbetapir F 18