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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Navidea Biopharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Navidea Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01812213
First received: March 12, 2013
Last updated: August 22, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Mild Cognitive Impairment
Drug: [18F]NAV4694
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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)

Resource links provided by NLM:


Further study details as provided by Navidea Biopharmaceuticals:

Primary Outcome Measures:
  • Incidence of Mild Cognitive Impairment Progression to Alzheimer's Disease [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
    Incidence of Mild Cognitive Impairment Progression to Alzheimer's Disease


Secondary Outcome Measures:
  • Incidence of [18F]NAV4694 PET Positive scans at 18 months compared to baseline [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Change in SUVR scores at 18 months compared to baseline

  • Incidence of Adverse Events post baseline [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]
    Incidence of Adverse Events post baseline


Estimated Enrollment: 120
Study Start Date: March 2013
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: [18F]NAV4694
Intravenous [18F]NAV4694 (8.1 mCi) administered once every 18 months
Drug: [18F]NAV4694

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01812213

Contacts
Contact: Carley Hartings, MPH 614-793-7500 ext 158 chartings@navidea.com
Contact: Diana DeMeo, BS 614-793-7500 ext 153 demeo@navidea.com

Locations
United States, Arizona
Banner Sun Health Research Institute Recruiting
Sun City, Arizona, United States, 85351
Contact: Christina Chong    632-832-8790    Christina.Chong@bannerhealth.com   
Principal Investigator: Marwan Sabbagh, M.D.         
United States, Florida
Galiz Research Recruiting
Hialeah, Florida, United States, 33016
Contact: Luis Pedraza    305-805-0921    luisp@galizresearch.com   
Principal Investigator: Jose Gamez, M.D.         
Mt. Sinai Wien Center for Alzheimer's Disease Active, not recruiting
Miami Beach, Florida, United States, 33140
Compass Research Recruiting
Orlando, Florida, United States, 32806
Contact: Tim Schubert    407-210-1329    tschubert@compassresearch.com   
Principal Investigator: Ira Goodman, MD         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Mary Messenger    312-942-6514    Mary_Messenger@rush.edu   
Principal Investigator: Raj Shah, M.D.         
Alexian Brothers Neurosciences Institute Withdrawn
Elk Grove Village, Illinois, United States, 60007
SIU School of Medicine Recruiting
Springfield, Illinois, United States, 62702
Contact: Barbara Lokaitis    217-545-9737    blokaitis@siumed.edu   
Principal Investigator: Thomas A Ala, M.D.         
United States, Massachusetts
McLean Hospital Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Melissa Pritchard    617-855-2649    mpritchard1@partners.org   
Principal Investigator: James M Ellison, M.D., MPH         
Qunicy Medical Center, Alzheimer's Disease Center Recruiting
Quincy, Massachusetts, United States, 02169
Contact: Hayley Brooks    617-302-6388    hayley@thealzcenter.org   
Principal Investigator: Anil Nair, MD         
United States, New York
Neurological Associates of Albany Recruiting
Albany, New York, United States, 12208
Contact: MaryEllen Torrisi    518-426-0575    research@naaresearch.com   
Principal Investigator: Richard Holub, MD         
Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10461
Contact: Khosrow Baigi    718-405-8363    krezagho@montefiore.org   
Principal Investigator: Jessica Zwerling, MD         
United States, North Carolina
Wake Forest School of Medicine Recruiting
Winston-Salem, North Carolina, United States, 21157
Contact: Rose Fries    336-713-8462    rfries@wakehealth.edu   
Principal Investigator: Kaycee Sink, M.D.         
Sponsors and Collaborators
Navidea Biopharmaceuticals
Investigators
Study Director: Cornelia Reininger, MD, PhD Navidea Biopharmaceuticals Inc.
  More Information

No publications provided

Responsible Party: Navidea Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT01812213     History of Changes
Other Study ID Numbers: NAV4-04
Study First Received: March 12, 2013
Last Updated: August 22, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Navidea Biopharmaceuticals:
Mild Cognitive Impairment

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Mild Cognitive Impairment
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 15, 2014