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) (NAV4-04)

• ClinicalTrials.gov Identifier: NCT01812213
• Recruitment Status: Unknown
• First Posted: March 18, 2013
• Last Update Posted: July 26, 2017
• Sponsor: Navidea Biopharmaceuticals
• Information provided by (Responsible Party): Navidea Biopharmaceuticals

Tracking Information

• First Submitted Date: March 12, 2013
• First Posted Date: March 18, 2013
• Last Update Posted Date: July 26, 2017
• Actual Study Start Date: March 2013
• Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 15, 2013)

Incidence of Mild Cognitive Impairment Progression to Alzheimer's Disease [ Time Frame: 3 Years ]

Incidence of Mild Cognitive Impairment Progression to Alzheimer's Disease

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: August 22, 2014)

• 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 Measures (submitted: March 15, 2013)

• 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

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief 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 (MCI)
• 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 (MCI)
• 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 Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Mild Cognitive Impairment
• Intervention: Drug: [18F]NAV4694

Study Arms

Experimental: [18F]NAV4694

Intravenous [18F]NAV4694 (8.1 mCi) administered once every 18 months

Intervention: Drug: [18F]NAV4694

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 12, 2014): 120
• Original Estimated Enrollment (submitted: March 15, 2013): 50
• Estimated Study Completion Date: August 2018
• Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Subject has signed informed consent to participate in the study and continues to give willing consent for participation
• Age ≥ 55 years with a diagnosis of MCI
• Educational level of at least 6 years
• Female subjects will not be of child-bearing potential (> 1 year post-menopausal or surgically sterile)
• Availability of a "study partner" who can assist in completing rating scales for the duration of the study
• Cognitive complaints reported by the subject and confirmed by the "study partner"
• Clinical Dementia Rating (CDR) global score = 0.5
• Mini-mental state examination (MMSE) score of 24-30
• Diagnostic and Statistical Manual of Mental Disorders, Version 4, Text Revised (DSM-IV-TR) criteria of dementia not fulfilled

Exclusion Criteria:

• Has been previously enrolled in this study and received the investigational product
• Has received an investigational product within 30 days prior to screening
• Has received disease-modifying therapy that could have changed amyloid brain deposition
• Has exceeded yearly radioactive dose of 30 mSv
• Has a known allergy to the study drug or any of its constituents
• Has a history of alcohol abuse or alcohol dependency in the 3 years prior to study entry, or is an alcoholic or drug addict, as determined by the investigator
• Has ongoing clinically significant (as judged by the investigator), metabolic or any other disease that could currently cause impaired memory (e.g., untreated thyroid disease, vitamin or other nutritional deficiencies, chronic kidney, or liver disease)
• Memory impairment that can be attributed to a disease or condition other than an early phase neurodegenerative syndrome
• Has a parkinsonian movement disorder
• Use of psychoactive medications that would affect the subject's ability to reliably perform neurocognitive testing or create uncertainty in distinguishing between the effects of the psychoactive medication and the subject's underlying cognitive impairment (e.g., benzodiazepines, sedatives, antipsychotics)
• Has received any contrast material (X-ray, MRI) or radiopharmaceutical within 48 hours prior to, or a therapeutic radiopharmaceutical (e.g., 131I) within 10 days prior to, or any radiopharmaceutical administration within 10 radioactive half-lives prior to the administration of the investigational product or for whom administration of such substances is planned within 7 days after investigational product administration
• History of major recurrent depressive disorder (per DSM-IV-TR) within the last 5 years prior to screening
• Has a brain tumor or other intracranial lesion, a disturbance of cerebral spinal fluid circulation (e.g., normal pressure hydrocephalus), and/or a significant history of head trauma or brain surgery
• Has signs of major cerebrovascular disease, as verified by medical history and/or brain MRI
• Is scheduled for surgery and/or another invasive procedure within the 7 days following investigational product administration
• Has any contraindication to MRI examination, e.g., metal implants, phobia, or cannot undergo an MRI for other reasons such as the inability to lie flat

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 55 Years to 99 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01812213
• Other Study ID Numbers: NAV4-04
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Navidea Biopharmaceuticals
• Study Sponsor: Navidea Biopharmaceuticals
• Collaborators: Not Provided

Investigators

• Study Director: Cornelia Reininger, MD, PhD; Navidea Biopharmaceuticals Inc.

• PRS Account: Navidea Biopharmaceuticals
• Verification Date: July 2017