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

NCT01812213 | Terminated Phase 2 Results

• 1 other identifier: NAV4-04
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 11

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.

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Incidence of Mild Cognitive Impairment Progression to Alzheimer's Disease

  Incidence of Mild Cognitive Impairment Progression to Alzheimer's Disease

  3 Years

Secondary Outcomes (9)

• 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

  6 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

  18 months

• Change in Neuro-cognitive Test Battery Scores at 24 Months Compared to Baseline

  24 months

Study Arms (1)

[18F]NAV4694

EXPERIMENTAL

Intravenous \[18F\]NAV4694 (8.1 mCi) administered once every 18 months

Drug: [18F]NAV4694

Interventions

[18F]NAV4694 DRUG

[18F]NAV4694

Eligibility Criteria

• Age: 55 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Navidea Biopharmaceuticals: lead

Study Sites (11)

Banner Sun Health Research Institute

Sun City, Arizona, 85351, United States

Location

Galiz Research

Hialeah, Florida, 33016, United States

Location

Mt. Sinai Wien Center for Alzheimer's Disease

Miami Beach, Florida, 33140, United States

Location

Compass Research

Orlando, Florida, 32806, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

SIU School of Medicine

Springfield, Illinois, 62702, United States

Location

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Qunicy Medical Center, Alzheimer's Disease Center

Quincy, Massachusetts, 02169, United States

Location

Neurological Associates of Albany

Albany, New York, 12208, United States

Location

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Wake Forest School of Medicine

Winston-Salem, North Carolina, 21157, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Navidea Biopharmaceuticals

mblue@navidea.com

6149737555

Study Officials

• Cornelia Reininger, MD, PhD

  Navidea Biopharmaceuticals Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2013
• First Posted: March 18, 2013
• Study Start: March 1, 2013
• Primary Completion: November 2, 2017
• Study Completion: November 2, 2017
• Last Updated: August 14, 2024
• Results First Posted: August 14, 2024

Record last verified: 2024-07

Locations

US (11)