Phase 2 N=28 Single-blind Diagnostic

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

Alzheimer's Disease · Frontotemporal Dementia

Bottom Line

View on ClinicalTrials.gov: NCT01890343 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2014

Primary outcome: Primary: Qualitative Amyloid Image Assessment — 2; 1; 8; 4 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: florbetapir 18F (Drug); 18F-FDG (Drug)
Age: Adult, Older Adult · 45+ yrs
Sex: All
Sponsor: Avid Radiopharmaceuticals
Primary completion: Dec 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Qualitative Amyloid Image Assessment	2; 1; 8; 4; 8; 2	—
PRIMARY Quantitative Amyloid Image Assessment	1.25; 1.29; 1.77	0.002 sig

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).

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01890343). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.