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Ability Of ([18F]-AV-45) PET Scan to Distinguish Alzheimer's Disease Subjects From Cognitively Normal Individuals

Primary Purpose

Alzheimer's Disease

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

florbetapir F 18

[11C]-PIB

About this trial

This is an interventional diagnostic trial for Alzheimer's Disease focused on measuring Amyloid imaging, Positron Emission Tomography, 18F-AV-45, florbetapir F 18, Diagnostic imaging

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Research Site

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00855868

First Posted

March 2, 2009

Last Updated

June 19, 2012

Sponsor

Avid Radiopharmaceuticals

Collaborators

American College of Radiology Imaging Network, General Electric

1. Study Identification

Unique Protocol Identification Number

NCT00855868

Brief Title

Ability Of ([18F]-AV-45) PET Scan to Distinguish Alzheimer's Disease Subjects From Cognitively Normal Individuals

Official Title

Evaluation of the Ability of a Novel [18F] Amyloid Ligand ([18F]-AV-45) to Distinguish Patients With a Clinical Diagnosis of Alzheimer's Disease From Cognitively Normal Elderly Individuals

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Avid Radiopharmaceuticals

Collaborators

American College of Radiology Imaging Network, General Electric

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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. There will be no clinically meaningful difference in the amyloid retention performance characteristics of [18F]-AV-45 and [l1C]PIB.

Detailed Description

15 patients with a clinical diagnosis of probable Alzheimer's disease and 15 cognitively normal elderly control subjects will receive both [18F]-AV-45 and [11C]PIB to compare the diagnostic performance characteristics of each amyloid ligand to distinguish AD from normal subjects. In addition to clinical diagnostic category, ligand retention will be evaluated with respect to measures of symptom severity and cerebrospinal fluid levels of amyloid and tau.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

Keywords

Amyloid imaging, Positron Emission Tomography, 18F-AV-45, florbetapir F 18, Diagnostic imaging

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

N/A

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

florbetapir F 18

Other Intervention Name(s)

18F-AV-45, Amyvid, florbetapir

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

[11C]-PIB

Other Intervention Name(s)

C-11 PIB

Intervention Description

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

Primary Outcome Measure Information:

Title

Description

Time Frame

28 d

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

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

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Ability Of ([18F]-AV-45) PET Scan to Distinguish Alzheimer's Disease Subjects From Cognitively Normal Individuals

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