Clinical trial NCT00702143: A Phase II Trial of 18F-AV-45 Positron Emission Tomography (PET) Imaging in Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)
Official title: An Open Label, Parallel Group, Multicenter Study, Evaluating the Safety and Imaging Characteristics of 18F-AV-45 in Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Mild Cognitive Impairment
Lead sponsor: Avid Radiopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-06-20
Enrollment: 184
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Evaluate 18F-AV-45 positron emission tomography (PET) imaging for distinguishing healthy control subjects, from subjects with Alzheimer's disease (AD) or Mild cognitive impairment (MCI).


Eligibility criteria: Inclusion Criteria AD:

* Male or female \>=50 years of age
* Meet National Institute of Neurological and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS) criteria for probable AD with MMSE score of 10-24

Inclusion Criteria MCI:

* Male or female \>=50 years of age
* Have a Clinical Dementia Rating (CDR) of 0.5
* MMSE \>24

Normal subjects:

* Male or female \>=50 years of age
* MMSE \>=29
* Normal on psychometric test battery at screening
* Provide informed consent

Exclusion Criteria:

* Have a history or current diagnosis of other neurologic disease
* Have had or currently have a diagnosis of other neurodegenerative disease
* Have participated in experimental therapy targeted to amyloid plaque

Primary outcomes:
measure: Qualitative Amyloid Image Assessment
timeFrame: 50-60 min after injection
measure: Mean Cortical to Cerebellum SUVR
timeFrame: 50-60 min after injection
Secondary outcomes:
measure: Proportion of Positive Florbetapir-PET Scans
timeFrame: 50-60 min after injection
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Sun City
country: United States
facility: Research Site
state: Arizona
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Costa Mesa
country: United States
facility: Research Site
state: California
city: New Haven
country: United States
facility: Research Site
state: Connecticut
city: Hallandale Beach
country: United States
facility: Research Site
state: Florida
city: Miami Beach
country: United States
facility: Research Site
state: Florida
city: St. Petersburg
country: United States
facility: Research Site
state: Florida
city: Sunrise
country: United States
facility: Research Site
state: Florida
city: West Palm Beach
country: United States
facility: Research Site
state: Florida
city: Albany
country: United States
facility: Research Site
state: New York
city: Winston-Salem
country: United States
facility: Research Site
state: North Carolina
city: Jenkintown
country: United States
facility: Research Site
state: Pennsylvania
city: Bennington
country: United States
facility: Research Site
state: Vermont
Study officials:
affiliation: Avid Radiopharmaceuticals
name: Chief Medical Officer
role: STUDY_DIRECTOR
References: