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Imaging Characteristics of Florbetapir 18F in Patients With Frontotemporal Dementia, Alzheimer's Disease and Normal Controls.

Primary Purpose

Alzheimer's Disease, Frontotemporal Dementia

Status

Completed

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

florbetapir 18F

18F-FDG

About this trial

This is an interventional diagnostic trial for Alzheimer's Disease

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

AD:

Male or female >= 50 years of age
Meet National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) criteria for probable AD and have a Mini Mental State Examination (MMSE) score at screening between 10 and 24 inclusive
Have a caregiver who can report on their mental status and activities of daily living (ADL)
Give informed consent or have a caregiver give consent with subject assent.

FTD:

Male or female >= 45 years of age
Meet consensus criteria for FTD and have mild to moderate disease severity. Have a caregiver who can report on their mental status and ADL
Give informed consent or have a caregiver give consent with subject assent.

CN:

Male or female >= 45 years of age
Have and MMSE >= 29
Give informed consent

Exclusion Criteria:

Have a history or a current clinically significant neurologic disease (other than AD or FTD, as applicable), a diagnosis of other dementing/neurodegenerative disease, or a diagnosis of mixed dementia
Evidence from MRI or other biomarkers that suggests an etiology of dementia other than AD or FTD, as applicable or in the case of CN subjects evidence indicating the presence of AD, FTD or other types of neurologic pathology
Have current clinically significant cardiovascular disease, screening ECG abnormalities, psychiatric disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, cancer or infectious disease
Have a recent history of alcohol or substance abuse or dependence
Women of childbearing potential who are not permanently surgically sterile, or are not refraining from sexual activity while not using adequate contraception.
Require medications with a narrow therapeutic window, are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days
Have ever participated in a study with an amyloid targeting agent
Have had a radiopharmaceutical imaging or treatment procedure within 7 days of the imaging, other than as defined in the protocol

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Frontotemporal Disorder

Cognitively Normal

Alzheimer's Disease

Arm Description

Subjects with frontotemporal disorder (FTD) received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F and a one-time IV bolus injection of 185 MBq of 18F-FDG.

Cognitively normal (CN) subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.

Subjects with Alzheimer's disease (AD) received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.

Outcomes

Primary Outcome Measures

Qualitative Amyloid Image Assessment

Four 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 classification is presented as either positive, negative or tied.

Quantitative Amyloid Image Assessment

The effect of diagnostic group on mean total cortical grey matter florbetapir binding relative to cerebellar cortex is presented as standard uptake value ratios (SUVr).

Secondary Outcome Measures

Full Information

NCT ID

NCT01890343

First Posted

June 27, 2013

Last Updated

September 16, 2014

Sponsor

Avid Radiopharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01890343

Brief Title

Imaging Characteristics of Florbetapir 18F in Patients With Frontotemporal Dementia, Alzheimer's Disease and Normal Controls.

Official Title

A Study Evaluating the Imaging Characteristics of Florbetapir 18F (18F-AV-45) in Patients With Frontotemporal Dementia Compared to Patients With Alzheimer's Disease and Normal Controls.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Avid Radiopharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Study 18F-AV-45-010 is designed to evaluate the cerebral uptake of florbetapir 18F as measured by PET imaging in frontotemporal disorder (FTD) in comparison to cognitively normal volunteers and subjects with Alzheimer's disease (AD).

6. Conditions and Keywords

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

Alzheimer's Disease, Frontotemporal Dementia

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Non-Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Frontotemporal Disorder

Arm Type

Experimental

Arm Description

Subjects with frontotemporal disorder (FTD) received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F and a one-time IV bolus injection of 185 MBq of 18F-FDG.

Arm Title

Cognitively Normal

Arm Type

Experimental

Arm Description

Cognitively normal (CN) subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.

Arm Title

Alzheimer's Disease

Arm Type

Experimental

Arm Description

Subjects with Alzheimer's disease (AD) received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.

Intervention Type

Drug

Intervention Name(s)

florbetapir 18F

Other Intervention Name(s)

Florbetapir F 18, 18F-AV-45, Amyvid

Intervention Description

Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.

Intervention Type

Drug

Intervention Name(s)

18F-FDG

Other Intervention Name(s)

FDG, fluorodeoxyglucose (18F), fludeoxyglucose (18F)

Intervention Description

FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG.

Primary Outcome Measure Information:

Title

Qualitative Amyloid Image Assessment

Description

Time Frame

50-60 min after injection

Title

Quantitative Amyloid Image Assessment

Description

The effect of diagnostic group on mean total cortical grey matter florbetapir binding relative to cerebellar cortex is presented as standard uptake value ratios (SUVr).

Time Frame

50-60 minutes after injection

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: AD: Male or female >= 50 years of age Meet National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) criteria for probable AD and have a Mini Mental State Examination (MMSE) score at screening between 10 and 24 inclusive Have a caregiver who can report on their mental status and activities of daily living (ADL) Give informed consent or have a caregiver give consent with subject assent. FTD: Male or female >= 45 years of age Meet consensus criteria for FTD and have mild to moderate disease severity. Have a caregiver who can report on their mental status and ADL Give informed consent or have a caregiver give consent with subject assent. CN: Male or female >= 45 years of age Have and MMSE >= 29 Give informed consent Exclusion Criteria: Have a history or a current clinically significant neurologic disease (other than AD or FTD, as applicable), a diagnosis of other dementing/neurodegenerative disease, or a diagnosis of mixed dementia Evidence from MRI or other biomarkers that suggests an etiology of dementia other than AD or FTD, as applicable or in the case of CN subjects evidence indicating the presence of AD, FTD or other types of neurologic pathology Have current clinically significant cardiovascular disease, screening ECG abnormalities, psychiatric disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, cancer or infectious disease Have a recent history of alcohol or substance abuse or dependence Women of childbearing potential who are not permanently surgically sterile, or are not refraining from sexual activity while not using adequate contraception. Require medications with a narrow therapeutic window, are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days Have ever participated in a study with an amyloid targeting agent Have had a radiopharmaceutical imaging or treatment procedure within 7 days of the imaging, other than as defined in the protocol

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

Manchester

ZIP/Postal Code

M20 3LJ

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Imaging Characteristics of Florbetapir 18F in Patients With Frontotemporal Dementia, Alzheimer's Disease and Normal Controls.

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