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

NCT ID: NCT01890343

Last Updated: 2014-09-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2013-04-30

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).

Conditions

Alzheimer's Disease; Frontotemporal Dementia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Frontotemporal Disorder

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.

Group Type: EXPERIMENTAL

florbetapir 18F

Intervention Type: DRUG

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

18F-FDG

Intervention Type: DRUG

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

Cognitively Normal

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

Group Type: EXPERIMENTAL

florbetapir 18F

Intervention Type: DRUG

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

Alzheimer's Disease

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

Group Type: EXPERIMENTAL

florbetapir 18F

Intervention Type: DRUG

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

Interventions

florbetapir 18F

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

Intervention Type: DRUG

18F-FDG

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

Intervention Type: DRUG

Other Intervention Names

Florbetapir F 18; 18F-AV-45; Amyvid; FDG; fluorodeoxyglucose (18F); fludeoxyglucose (18F)

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Avid Radiopharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chief Medical Officer

Role: STUDY_DIRECTOR

Avid Radiopharmaceuticals

Locations

Research Site

Manchester, , United Kingdom

Countries

United Kingdom

Other Identifiers

18F-AV-45-010

Identifier Type: -

Identifier Source: org_study_id