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)

Mild Cognitive Impairment Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00702143
• Other study ID #: 18F-AV-45-A05
• Status: Completed
• Phase: Phase 2
• First received: June 19, 2008
• Last updated: May 8, 2012
• Start date: June 2008
• Est. completion date: December 2008

Study information

• Verified date: May 2012
• Source: Avid Radiopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Cognition Disorders
• Mild Cognitive Impairment

Intervention

Drug:
• florbetapir F 18
IV injection, 370MBq (10mCi), single dose

Locations

Country	Name	City	State
United States	Research Site	Albany	New York
United States	Research Site	Bennington	Vermont
United States	Research Site	Costa Mesa	California
United States	Research Site	Hallandale Beach	Florida
United States	Research Site	Jenkintown	Pennsylvania
United States	Research Site	Miami Beach	Florida
United States	Research Site	New Haven	Connecticut
United States	Research Site	Phoenix	Arizona
United States	Research Site	Scottsdale	Arizona
United States	Research Site	St. Petersburg	Florida
United States	Research Site	Sun City	Arizona
United States	Research Site	Sunrise	Florida
United States	Research Site	Tucson	Arizona
United States	Research Site	West Palm Beach	Florida
United States	Research Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Avid Radiopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative Amyloid Image Assessment	Three 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 was the primary efficacy endpoint for the qualitative evaluation.	50-60 min after injection	No
Primary	Mean Cortical to Cerebellum SUVR	Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.	50-60 min after injection	No
Secondary	Proportion of Positive Florbetapir-PET Scans	Three readers blinded to all clinical information classified florbetapir-PET images as either positive for amyloid or negative for amyloid. The majority read was used to determine the proportion of positive scans across the three groups.	50-60 min after injection	No