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

Alzheimer's Disease Clinical Trial

Official title:

Test-retest Reproducibility of 18F-AV-45 for Brain Imaging of Amyloid in Healthy Volunteers and Alzheimer's Disease Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01565343
• Other study ID #: 18F-AV-45-A04
• Status: Completed
• Phase: Phase 1
• First received: March 26, 2012
• Last updated: May 8, 2012
• Start date: April 2008
• Est. completion date: April 2009

Study information

• Verified date: May 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• 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: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• florbetapir F 18
IV injection, 370MBq (10mCi)

Locations

Country	Name	City	State
United States	Research Site	Hallandale Beach	Florida
United States	Research Site	New Haven	Connecticut
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	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.	50-70 min after injection	No