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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)

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ClinicalTrials.gov Identifier: NCT01812213
Recruitment Status : Unknown
Verified July 2017 by Navidea Biopharmaceuticals.
Recruitment status was:  Active, not recruiting
First Posted : March 18, 2013
Last Update Posted : July 26, 2017
Sponsor:
Information provided by (Responsible Party):
Navidea Biopharmaceuticals

Tracking Information
First Submitted Date  ICMJE March 12, 2013
First Posted Date  ICMJE March 18, 2013
Last Update Posted Date July 26, 2017
Actual Study Start Date  ICMJE March 2013
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE 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  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Mild Cognitive Impairment
Intervention  ICMJE Drug: [18F]NAV4694
Study Arms  ICMJE Experimental: [18F]NAV4694
Intravenous [18F]NAV4694 (8.1 mCi) administered once every 18 months
Intervention: Drug: [18F]NAV4694
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 12, 2014)
120
Original Estimated Enrollment  ICMJE
 (submitted: March 15, 2013)
50
Estimated Study Completion Date  ICMJE August 2018
Estimated Primary Completion Date June 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01812213
Other Study ID Numbers  ICMJE NAV4-04
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Navidea Biopharmaceuticals
Study Sponsor  ICMJE Navidea Biopharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Cornelia Reininger, MD, PhD Navidea Biopharmaceuticals Inc.
PRS Account Navidea Biopharmaceuticals
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP