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

Primary Purpose

Alzheimer 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 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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

111 MBq (3 mCi) AD Group

111 MBq (3 mCi) Control Group

370 MBq (10 mCi) AD Group

370 MBq (10 mCi) Control Group

Arm Description

Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel

Healthy controls who received 111MBq (3 mCi) of florbetapir F 18

Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18

Healthy controls who received 370MBq (10 mCi) of florbetapir F 18.

Outcomes

Primary Outcome Measures

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).

Secondary 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.

Full Information

First Posted
March 26, 2012
Last Updated
June 14, 2012
Sponsor
Avid Radiopharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01565330
Brief Title
A Study of Two Doses of 18F-AV-45 in Alzheimer's Disease and Healthy Volunteers
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)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer 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
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
111 MBq (3 mCi) AD Group
Arm Type
Experimental
Arm Description
Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
Arm Title
111 MBq (3 mCi) Control Group
Arm Type
Experimental
Arm Description
Healthy controls who received 111MBq (3 mCi) of florbetapir F 18
Arm Title
370 MBq (10 mCi) AD Group
Arm Type
Experimental
Arm Description
Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18
Arm Title
370 MBq (10 mCi) Control Group
Arm Type
Experimental
Arm Description
Healthy controls who received 370MBq (10 mCi) of florbetapir F 18.
Intervention Type
Drug
Intervention Name(s)
florbetapir F 18
Other Intervention Name(s)
18F-AV-45, Amyvid, florbetapir
Intervention Description
single dose IV injection
Primary Outcome Measure Information:
Title
Florbetapir-PET Scan Quality
Description
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).
Time Frame
0-90 min after injection
Secondary 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
0-90 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
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
Facility Name
Research Site
City
Clementon
State/Province
New Jersey
ZIP/Postal Code
08021
Country
United States

12. IPD Sharing Statement

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

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