Clinical Trial: Beta-Amyloid Imaging With [18F]NAV4694 Positron Emission Tomography (PET) in Predicting Progression to Alzheimer's Disease (AD) in Subjects With Mild Cognitive Impairment (MCI)
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Beta-Amyloid Imaging With [18F]NAV4694 Positron Emission Tomography (PET) in Predicting Progression to Alzheimer's Disease (AD) in Subjects With Mild Cognitive Impairment
Brief Summary: To investigate whether [18F]NAV4694 positron emission tomography (PET) scan findings have the ability to distinguish subjects with mild cognitive impairment (MCI) who progress to Alzheimer's disease (AD) from those who do not.
Detailed Summary:
Sponsor: Navidea Biopharmaceuticals
Current Primary Outcome: Incidence of Mild Cognitive Impairment Progression to Alzheimer's Disease [ Time Frame: 3 Years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Incidence of [18F]NAV4694 PET Positive scans at 18 months compared to baseline [ Time Frame: 18 months ]Incidence of [18F]NAV4694 PET Positive scans at 18 months compared to baseline
- Change in Neuro-cognitive Test Battery Scores at 6 months compared to baseline [ Time Frame: 6 months ]Change in Neuro-cognitive Test Battery Scores at 6 months compared to baseline
- Change in Neuro-cognitive Test Battery Scores at 12 months compared to baseline [ Time Frame: 12 months ]Change in Neuro-cognitive Test Battery Scores at 12 months compared to baseline
- Change in Neuro-cognitive Test Battery Scores at 18 months compared to baseline [ Time Frame: 18 months ]Change in Neuro-cognitive Test Battery Scores at 18 months compared to baseline
- Change in Neuro-cognitive Test Battery Scores at 24 months compared to baseline [ Time Frame: 24 months ]Change in Neuro-cognitive Test Battery Scores at 24 months compared to baseline
- Change in Neuro-cognitive Test Battery Scores at 30 months compared to baseline [ Time Frame: 30 months ]Change in Neuro-cognitive Test Battery Scores at 30 months compared to baseline
- Change in Neuro-cognitive Test Battery Scores at 36 months compared to baseline [ Time Frame: 36 months ]Change in Neuro-cognitive Test Battery Scores at 36 months compared to baseline
- Change in SUVR scores at 18 months compared to baseline [ Time Frame: 36 months ]Change in SUVR scores at 18 months compared to baseline
- Incidence of Adverse Events post baseline [ Time Frame: 3 Years ]Incidence of Adverse Events post baseline
Original Secondary Outcome:
- Incidence of [18F]NAV4694 PET Positive scans at 18 months compared to baseline [ Time Frame: 18 months ]Incidence of [18F]NAV4694 PET Positive scans at 18 months compared to baseline
- Incidence of [18F]NAV4694 PET Positive scans at 36 months compared to baseline [ Time Frame: 3 years ]Incidence of [18F]NAV4694 PET Positive scans at 36 months compared to baseline
- Change in Neuro-cognitive Test Battery Scores at 6 months compared to baseline [ Time Frame: 6 months ]Change in Neuro-cognitive Test Battery Scores at 6 months compared to baseline
- Change in Neuro-cognitive Test Battery Scores at 12 months compared to baseline [ Time Frame: 12 months ]Change in Neuro-cognitive Test Battery Scores at 12 months compared to baseline
- Change in Neuro-cognitive Test Battery Scores at 18 months compared to baseline [ Time Frame: 18 months ]Change in Neuro-cognitive Test Battery Scores at 18 months compared to baseline
- Change in Neuro-cognitive Test Battery Scores at 24 months compared to baseline [ Time Frame: 24 months ]Change in Neuro-cognitive Test Battery Scores at 24 months compared to baseline
- Change in Neuro-cognitive Test Battery Scores at 30 months compared to baseline [ Time Frame: 30 months ]Change in Neuro-cognitive Test Battery Scores at 30 months compared to baseline
- Change in Neuro-cognitive Test Battery Scores at 36 months compared to baseline [ Time Frame: 36 months ]Change in Neuro-cognitive Test Battery Scores at 36 months compared to baseline
- Change in SUVR scores at 18 months compared to baseline [ Time Frame: 36 months ]Change in SUVR scores at 18 months compared to baseline
- Incidence of Adverse Events post baseline [ Time Frame: 3 Years ]Incidence of Adverse Events post baseline
Information By: Navidea Biopharmaceuticals
Dates:
Date Received: March 12, 2013
Date Started: March 2013
Date Completion:
Last Updated: March 29, 2016
Last Verified: March 2016