NCT01565343

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2008

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2012

Completed
1 month until next milestone

Results Posted

Study results publicly available

May 2, 2012

Completed
Last Updated

May 10, 2012

Status Verified

May 1, 2012

Enrollment Period

1 year

First QC Date

March 26, 2012

Results QC Date

April 6, 2012

Last Update Submit

May 8, 2012

Conditions

Alzheimer's Disease

Keywords

Amyloid imagingPositron Emission Tomography18F-AV-45florbetapir F 18Diagnostic imaging

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

AD Subjects

EXPERIMENTAL

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

Drug: florbetapir F 18

AD Subjects: Slow vs. Fast Bolus

EXPERIMENTAL

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).

Drug: florbetapir F 18

Healthy controls

EXPERIMENTAL

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

Drug: florbetapir F 18

Interventions

florbetapir F 18DRUG

IV injection, 370MBq (10mCi)

Also known as: 18F-AV-45, Amyvid, florbetapir
AD SubjectsAD Subjects: Slow vs. Fast BolusHealthy controls

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • to 55 years of age, inclusive
  • MMSE of 29 or greater

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research Site

New Haven, Connecticut, 06510, United States

Location

Research Site

Hallandale, Florida, 33009, United States

Location

Research Site

West Palm Beach, Florida, 33407, United States

Location

Research Site

North East, Maryland, 21901, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

florbetapir

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Chief Medical Officer
Organization
Avid Radiopharmaceuticals
clinicaloperations@avidrp.com
215-298-0700

Study Officials

  • Chief Medical Officer

    Avid Radiopharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2012

First Posted

March 28, 2012

Study Start

April 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

May 10, 2012

Results First Posted

May 2, 2012

Record last verified: 2012-05

Locations

US(4)