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

Alzheimer's Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01890343
• Other study ID #: 18F-AV-45-010
• Status: Completed
• Phase: Phase 2
• First received: June 27, 2013
• Last updated: September 16, 2014
• Start date: September 2009
• Est. completion date: April 2013

Study information

• Verified date: September 2014
• Source: Avid Radiopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: April 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Aphasia, Primary Progressive
• Dementia
• Frontotemporal Dementia
• Pick Disease of the Brain

Intervention

Drug:
• florbetapir 18F
Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
• 18F-FDG
FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG.

Locations

Country	Name	City	State
United Kingdom	Research Site	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Avid Radiopharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	50-60 min after injection	No
Primary	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).	50-60 minutes after injection	No