NCT00702143

Brief Summary

Evaluate 18F-AV-45 positron emission tomography (PET) imaging for distinguishing healthy control subjects, from subjects with Alzheimer's disease (AD) or Mild cognitive impairment (MCI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
184

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

15 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

June 1, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 20, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

May 3, 2012

Completed
Last Updated

May 10, 2012

Status Verified

May 1, 2012

Enrollment Period

6 months

First QC Date

June 19, 2008

Results QC Date

April 6, 2012

Last Update Submit

May 8, 2012

Conditions

Alzheimer's DiseaseMild Cognitive Impairment

Outcome Measures

Primary Outcomes (2)

  • Qualitative Amyloid Image Assessment

    Three readers blinded to all clinical information classified florbetapir-Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read was the primary efficacy endpoint for the qualitative evaluation.

    50-60 min after injection

  • 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.

    50-60 min after injection

Secondary Outcomes (1)

  • Proportion of Positive Florbetapir-PET Scans

    50-60 min after injection

Study Arms (3)

AD subjects

EXPERIMENTAL
Drug: florbetapir F 18

MCI Subjects

EXPERIMENTAL

MCI (mild cognitive impairment)

Drug: florbetapir F 18

Healthy controls

EXPERIMENTAL
Drug: florbetapir F 18

Interventions

florbetapir F 18DRUG

IV injection, 370MBq (10mCi), single dose

Also known as: 18F-AV-45, Amyvid, florbetapir
AD subjectsHealthy controlsMCI Subjects

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female \>=50 years of age
  • Meet National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS) criteria for probable AD with MMSE score of 10-24
  • Male or female \>=50 years of age
  • Have a Clinical Dementia Rating (CDR) of 0.5
  • MMSE \>24
  • Normal subjects:
  • Male or female \>=50 years of age
  • MMSE \>=29
  • Normal on psychometric test battery at screening
  • Provide informed consent

You may not qualify if:

  • Have a history or current diagnosis of other neurologic disease
  • Have had or currently have a diagnosis of other neurodegenerative disease
  • Have participated in experimental therapy targeted to amyloid plaque

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Research Site

Phoenix, Arizona, 85006, United States

Location

Research Site

Scottsdale, Arizona, 85252, United States

Location

Research Site

Sun City, Arizona, 85210, United States

Location

Research Site

Tucson, Arizona, 85741, United States

Location

Research Site

Costa Mesa, California, 92626, United States

Location

Research Site

New Haven, Connecticut, 06510, United States

Location

Research Site

Hallandale, Florida, 33064, United States

Location

Research Site

Miami Beach, Florida, 33140, United States

Location

Research Site

St. Petersburg, Florida, 33702, United States

Location

Research Site

Sunrise, Florida, 33351, United States

Location

Research Site

West Palm Beach, Florida, 33407, United States

Location

Research Site

Albany, New York, 12208, United States

Location

Research Site

Winston-Salem, North Carolina, 27103, United States

Location

Research Site

Jenkintown, Pennsylvania, 19046, United States

Location

Research Site

Bennington, Vermont, 05201, United States

Location

MeSH Terms

Conditions

Alzheimer DiseaseCognitive Dysfunction

Interventions

florbetapir

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition 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 2
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

June 19, 2008

First Posted

June 20, 2008

Study Start

June 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

May 10, 2012

Results First Posted

May 3, 2012

Record last verified: 2012-05

Locations

US(15)