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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Mild Cognitive Impairment	Drug: [18F]NAV4694	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 120 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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)
• Actual Study Start Date: March 2013
• Estimated Primary Completion Date: June 2018
• Estimated Study Completion Date: August 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: [18F]NAV4694; Intravenous [18F]NAV4694 (8.1 mCi) administered once every 18 months	Drug: [18F]NAV4694

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. 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
2. 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
3. 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
4. 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
5. 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
6. 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
7. 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
8. Change in SUVR scores at 18 months compared to baseline [ Time Frame: 36 months ]
   Change in SUVR scores at 18 months compared to baseline
9. Incidence of Adverse Events post baseline [ Time Frame: 3 Years ]
   Incidence of Adverse Events post baseline

Eligibility Criteria

• Ages Eligible for Study: 55 Years to 99 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Arizona

Banner Sun Health Research Institute

Sun City, Arizona, United States, 85351

United States, Florida

Galiz Research

Hialeah, Florida, United States, 33016

Mt. Sinai Wien Center for Alzheimer's Disease

Miami Beach, Florida, United States, 33140

Compass Research

Orlando, Florida, United States, 32806

United States, Illinois

Rush University Medical Center

Chicago, Illinois, United States, 60612

SIU School of Medicine

Springfield, Illinois, United States, 62702

United States, Massachusetts

McLean Hospital

Belmont, Massachusetts, United States, 02478

Qunicy Medical Center, Alzheimer's Disease Center

Quincy, Massachusetts, United States, 02169

United States, New York

Neurological Associates of Albany

Albany, New York, United States, 12208

Albert Einstein College of Medicine

The Bronx, New York, United States, 10461

United States, North Carolina

Wake Forest School of Medicine

Winston-Salem, North Carolina, United States, 21157

Sponsors and Collaborators

Navidea Biopharmaceuticals

Investigators

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

More Information

• Responsible Party: Navidea Biopharmaceuticals
• ClinicalTrials.gov Identifier: NCT01812213
• Other Study ID Numbers: NAV4-04
• First Posted: March 18, 2013
• Last Update Posted: July 26, 2017
• Last Verified: July 2017

Keywords provided by Navidea Biopharmaceuticals:

Mild Cognitive Impairment

Additional relevant MeSH terms:

Alzheimer Disease; Cognitive Dysfunction; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders