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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
florbetapir F 18
Sponsored by
Avid Radiopharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer's Disease focused on measuring Amyloid imaging, Positron Emission Tomography, 18F-AV-45, florbetapir F 18, Diagnostic imaging

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

AD Subjects

AD Subjects: Slow vs. Fast Bolus

Healthy controls

Arm Description

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

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).

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 26, 2012
Last Updated
May 8, 2012
Sponsor
Avid Radiopharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01565343
Brief Title
A Study of 18F-AV-45 in Alzheimer's Disease (AD) and Healthy Volunteers
Official Title
Test-retest Reproducibility of 18F-AV-45 for Brain Imaging of Amyloid in Healthy Volunteers and Alzheimer's Disease Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Avid Radiopharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Amyloid imaging, Positron Emission Tomography, 18F-AV-45, florbetapir F 18, Diagnostic imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AD Subjects
Arm Type
Experimental
Arm Description
Two bolus IV injections followed by brain PET scan up to 4 weeks apart
Arm Title
AD Subjects: Slow vs. Fast Bolus
Arm Type
Experimental
Arm 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).
Arm Title
Healthy controls
Arm Type
Experimental
Arm Description
Healthy male or female subjects; 35-55 years old. Two bolus IV injections followed by brain PET scan up to 4 weeks apart
Intervention Type
Drug
Intervention Name(s)
florbetapir F 18
Other Intervention Name(s)
18F-AV-45, Amyvid, florbetapir
Intervention Description
IV injection, 370MBq (10mCi)
Primary Outcome Measure Information:
Title
Mean Cortical to Cerebellum SUVR
Description
Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.
Time Frame
50-70 min after injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chief Medical Officer
Organizational Affiliation
Avid Radiopharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Research Site
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
Research Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Research Site
City
North East
State/Province
Maryland
ZIP/Postal Code
21901
Country
United States

12. IPD Sharing Statement

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

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