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)

• ClinicalTrials.gov Identifier: NCT00702143
• Recruitment Status: Completed
• First Posted: June 20, 2008
• Results First Posted: May 3, 2012
• Last Update Posted: May 10, 2012
• Sponsor: Avid Radiopharmaceuticals
• Information provided by (Responsible Party): Avid Radiopharmaceuticals

Tracking Information

• First Submitted Date: June 19, 2008
• First Posted Date: June 20, 2008
• Results First Submitted Date: April 6, 2012
• Results First Posted Date: May 3, 2012
• Last Update Posted Date: May 10, 2012
• Study Start Date: June 2008
• Actual Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 8, 2012)

• Qualitative Amyloid Image Assessment [ Time Frame: 50-60 min after injection ]
  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.
• Mean Cortical to Cerebellum SUVR [ Time Frame: 50-60 min after injection ]
  Standardized Uptake Value ratio (SUVR) is the ratio of tracer uptake in predefined cortical regions, relative to uptake in the whole cerebellum.

• Original Primary Outcome Measures (submitted: June 19, 2008): Presence or absence of amyloid plaque on the 18F-AV-45 PET scan as determined by image readers blinded to all clinical information. Safety evaluations of subjects undergoing AV-45 PET scan. [ Time Frame: at close of enrollment for study ]

Current Secondary Outcome Measures (submitted: March 25, 2012)

Proportion of Positive Florbetapir-PET Scans [ Time Frame: 50-60 min after injection ]

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.

• Original Secondary Outcome Measures (submitted: June 19, 2008): Determine rates of AV-45 PET scan positivity in AD, MCI and healthy normal subjects. [ Time Frame: at end of enrollment ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)
• 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).
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Diagnostic

Condition

• Alzheimer's Disease
• Mild Cognitive Impairment

Intervention

Drug: florbetapir F 18

IV injection, 370MBq (10mCi), single dose

Other Names:

• 18F-AV-45
• Amyvid
• florbetapir

Study Arms

• Experimental: AD subjects
  Intervention: Drug: florbetapir F 18
• Experimental: MCI Subjects
  MCI (mild cognitive impairment)
  Intervention: Drug: florbetapir F 18
• Experimental: Healthy controls
  Intervention: Drug: florbetapir F 18

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 21, 2011): 184
• Original Estimated Enrollment (submitted: June 19, 2008): 200
• Actual Study Completion Date: December 2008
• Actual Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00702143
• Other Study ID Numbers: 18F-AV-45-A05
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Avid Radiopharmaceuticals
• Original Responsible Party: Michael Pontecorvo/Vice President, Clinical Development, Avid Radiopharmaceuticals, Inc.
• Current Study Sponsor: Avid Radiopharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Chief Medical Officer; Avid Radiopharmaceuticals

• PRS Account: Avid Radiopharmaceuticals
• Verification Date: May 2012