NCT01565330

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 alzheimer-disease

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_1 alzheimer-disease

Geographic Reach
1 country

3 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

March 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
3.7 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

June 18, 2012

Status Verified

June 1, 2012

Enrollment Period

5 months

First QC Date

March 26, 2012

Results QC Date

April 6, 2012

Last Update Submit

June 14, 2012

Conditions

Alzheimer Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Mean Cortical to Cerebellum SUVR

    0-90 min after injection

Study Arms (4)

111 MBq (3 mCi) AD Group

EXPERIMENTAL

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

Drug: florbetapir F 18

111 MBq (3 mCi) Control Group

EXPERIMENTAL

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

Drug: florbetapir F 18

370 MBq (10 mCi) AD Group

EXPERIMENTAL

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

Drug: florbetapir F 18

370 MBq (10 mCi) Control Group

EXPERIMENTAL

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

Drug: florbetapir F 18

Interventions

florbetapir F 18DRUG

single dose IV injection

Also known as: 18F-AV-45, Amyvid, florbetapir
111 MBq (3 mCi) AD Group111 MBq (3 mCi) Control Group370 MBq (10 mCi) AD Group370 MBq (10 mCi) Control Group

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 (3)

Research Site

West Palm Beach, Florida, 33407, United States

Location

Research Site

North East, Maryland, 21901, United States

Location

Research Site

Clementon, New Jersey, 08021, 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
215-290-0700

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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2012

First Posted

March 28, 2012

Study Start

March 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

June 18, 2012

Results First Posted

May 2, 2012

Record last verified: 2012-06

Locations

US(3)