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

Alzheimer Disease Clinical Trial

Official title:

An Open Label, Parallel Group, Dose Comparison of Safety and Imaging Characteristics of 111 and 370 MBq (3 and 10 mCi) of 18F-AV-45 for Brain Imaging of Amyloid in Healthy Volunteers and Patients With Alzheimer's Disease (AD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01565330
• Other study ID #: 18F-AV-45-A03
• Status: Completed
• Phase: Phase 1
• First received: March 26, 2012
• Last updated: June 14, 2012
• Start date: March 2008
• Est. completion date: August 2008

Study information

• Verified date: June 2012
• Source: Avid Radiopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will test two different doses of florbetapir F 18 to determine which dose is best to image amyloid plaques in the brains of Alzheimer's Disease (AD) patients using a positron emission tomography (PET) scanner.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Drug:
• florbetapir F 18
single dose IV injection

Locations

Country	Name	City	State
United States	Research Site	Clementon	New Jersey
United States	Research Site	North East	Maryland
United States	Research Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Avid Radiopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Florbetapir-PET Scan Quality	Visual evaluation of image quality by nuclear medicine specialist blinded to dose and clinical information; reported on a 5-point scale (5=excellent and 1=poor).	0-90 min after injection	No
Secondary	Mean Cortical to Cerebellum SUVR	Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.	0-90 min after injection	No