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)

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.

Study Overview

• Status: Unknown
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Drug: [18F]NAV4694

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Sun City, Arizona, United States, 85351
      • Banner Sun Health Research Institute
  • Florida
    • Hialeah, Florida, United States, 33016
      • Galiz Research
    • Miami Beach, Florida, United States, 33140
      • Mt. Sinai Wien Center for Alzheimer's Disease
    • Orlando, Florida, United States, 32806
      • Compass Research
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Springfield, Illinois, United States, 62702
      • SIU School of Medicine
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • McLean Hospital
    • Quincy, Massachusetts, United States, 02169
      • Qunicy Medical Center, Alzheimer's Disease Center
  • New York
    • Albany, New York, United States, 12208
      • Neurological Associates of Albany
    • The Bronx, New York, United States, 10461
      • Albert Einstein College of Medicine
  • North Carolina
    • Winston-Salem, North Carolina, United States, 21157
      • Wake Forest School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: [18F]NAV4694; Intravenous [18F]NAV4694 (8.1 mCi) administered once every 18 months	Drug: [18F]NAV4694

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Mild Cognitive Impairment Progression to Alzheimer's Disease	Incidence of Mild Cognitive Impairment Progression to Alzheimer's Disease	3 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of [18F]NAV4694 PET Positive scans at 18 months compared to baseline	Incidence of [18F]NAV4694 PET Positive scans at 18 months compared to baseline	18 months
Change in Neuro-cognitive Test Battery Scores at 6 months compared to baseline	Change in Neuro-cognitive Test Battery Scores at 6 months compared to baseline	6 months
Change in Neuro-cognitive Test Battery Scores at 12 months compared to baseline	Change in Neuro-cognitive Test Battery Scores at 12 months compared to baseline	12 months
Change in Neuro-cognitive Test Battery Scores at 18 months compared to baseline	Change in Neuro-cognitive Test Battery Scores at 18 months compared to baseline	18 months
Change in Neuro-cognitive Test Battery Scores at 24 months compared to baseline	Change in Neuro-cognitive Test Battery Scores at 24 months compared to baseline	24 months
Change in Neuro-cognitive Test Battery Scores at 30 months compared to baseline	Change in Neuro-cognitive Test Battery Scores at 30 months compared to baseline	30 months
Change in Neuro-cognitive Test Battery Scores at 36 months compared to baseline	Change in Neuro-cognitive Test Battery Scores at 36 months compared to baseline	36 months
Change in SUVR scores at 18 months compared to baseline	Change in SUVR scores at 18 months compared to baseline	36 months
Incidence of Adverse Events post baseline	Incidence of Adverse Events post baseline	3 Years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2013
• Primary Completion (ANTICIPATED): June 1, 2018
• Study Completion (ANTICIPATED): August 1, 2018

Study Registration Dates

• First Submitted: March 12, 2013
• First Submitted That Met QC Criteria: March 15, 2013
• First Posted (ESTIMATE): March 18, 2013

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2017
• Last Update Submitted That Met QC Criteria: July 25, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Mild Cognitive Impairment
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: NAV4-04