NCT00855868

Brief Summary

This study will evaluate the performance characteristics of a novel \[18F\] amyloid detection ligand (18F\]-AV-45) with respect to its ability to distinguish patients with clinically-diagnosed probable Alzheimer's disease from cognitively normal elderly subjects and to independently compare its diagnostic performance characteristics with the ability of \[11C\]PIB to correctly categorize the same subjects. SPECIFIC HYPOTHESES

  1. 1.Individuals with a clinical diagnosis of probable Alzheimer's disease will have increased brain retention of \[18F\]-AV-45 compared to cognitively normal elderly individuals.
  2. 2.There will be no clinically meaningful difference in the amyloid retention performance characteristics of \[18F\]-AV-45 and \[l1C\]PIB.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

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, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 5, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

July 26, 2012

Completed
Last Updated

July 26, 2012

Status Verified

June 1, 2012

Enrollment Period

1.8 years

First QC Date

March 2, 2009

Results QC Date

May 4, 2012

Last Update Submit

June 19, 2012

Conditions

Alzheimer's Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Differences in Standard Uptake Value Ratio (SUVR) for Frontal Cortex/Cerebellum and Whole Brain/Cerebellum of the Positron Emission Tomography (PET) Scan With [18F]-AV-45 for Probable Alzheimer's Disease (AD) Versus Cognitively Normal Subjects.

    Standardized Uptake Value ratio (SUVR) as measured in this study indicates the ratio of tracer uptake in the frontal cortex relative to the cerebellum or the ratio of tracer uptake in the whole brain relative to the cerebellum.

    28 d

Interventions

florbetapir F 18DRUG

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

Also known as: 18F-AV-45, Amyvid, florbetapir
[11C]-PIBDRUG

555 MBq (15 mCi), IV injection, single dose \[11C\]-PIB

Also known as: C-11 PIB

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Normal subjects: mini-mental state examination (MMSE) 27-30, clinical dementia rating (CDR) = 0, no symptoms of depression
  • Alzheimer's subjects: MMSE 18-26, CDR \>=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI

You may not qualify if:

  • other neurological disease
  • evidence of MRI abnormality
  • psychiatric disorder
  • alcohol abuse
  • clinically significant lab abnormalities
  • residence in nursing facility
  • participation in clinical trial with experimental medication in past 1 month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

florbetapir2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole

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
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2009

First Posted

March 5, 2009

Study Start

March 1, 2009

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

July 26, 2012

Results First Posted

July 26, 2012

Record last verified: 2012-06

Locations

US(1)