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

NCT01890343 | Completed Phase 2 Results

• 1 other identifier: 18F-AV-45-010
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (3)

Frontotemporal Disorder

EXPERIMENTAL

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.

Drug: florbetapir 18F; Drug: 18F-FDG

Cognitively Normal

EXPERIMENTAL

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

Drug: florbetapir 18F

Alzheimer's Disease

EXPERIMENTAL

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

Drug: florbetapir 18F

Interventions

florbetapir 18F DRUG

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

Also known as: Florbetapir F 18, 18F-AV-45, Amyvid

Alzheimer's Disease; Cognitively Normal; Frontotemporal Disorder

18F-FDG DRUG

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

Also known as: FDG, fluorodeoxyglucose (18F), fludeoxyglucose (18F)

Frontotemporal Disorder

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Avid Radiopharmaceuticals: lead

Study Sites (1)

Research Site

Manchester, M20 3LJ, United Kingdom

Location

MeSH Terms

Conditions

Alzheimer Disease; Frontotemporal Dementia

Interventions

florbetapir; Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

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
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2013
• First Posted: July 1, 2013
• Study Start: September 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: April 1, 2013
• Last Updated: September 29, 2014
• Results First Posted: September 17, 2014

Record last verified: 2014-09

Locations

GB (1)