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)
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 |
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).
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
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 |
Lead Sponsor | Collaborator |
---|---|
Avid Radiopharmaceuticals |
United States,
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 |
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