Beta-Amyloid Imaging With [18F]NAV4694 PET in Predicting Progression to AD in Subjects MCI (NAV4-04)

July 23, 2024 updated by: Navidea Biopharmaceuticals

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)

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
      • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of Mild Cognitive Impairment Progression to Alzheimer's Disease
Time Frame: 3 Years
Incidence of Mild Cognitive Impairment Progression to Alzheimer's Disease
3 Years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
18 months
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
6 months
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
12 months
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
18 months
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
24 months
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
30 months
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
36 months
Change in SUVR Scores at 18 Months Compared to Baseline
Time Frame: 36 months
Change in SUVR scores at 18 months compared to baseline
36 months
Incidence of Adverse Events Post Baseline
Time Frame: 3 Years
Incidence of Adverse Events post baseline
3 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Navidea Biopharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Cornelia Reininger, MD, PhD, Navidea Biopharmaceuticals Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 2, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 2, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NAV4-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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