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)

Mild Cognitive Impairment Clinical Trial

— NAV4-04  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01812213
• Other study ID #: NAV4-04
• Status: Active, not recruiting
• Phase: Phase 2
• First received: March 12, 2013
• Last updated: July 25, 2017
• Start date: March 2013
• Est. completion date: August 2018

Study information

• Verified date: July 2017
• Source: Navidea Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: August 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognition Disorders
• Mild Cognitive Impairment

Intervention

Drug:
• [18F]NAV4694

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Navidea Biopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Mild Cognitive Impairment Progression to Alzheimer's Disease	Incidence of Mild Cognitive Impairment Progression to Alzheimer's Disease	3 Years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in SUVR scores at 18 months compared to baseline	Change in SUVR scores at 18 months compared to baseline	36 months
Secondary	Incidence of Adverse Events post baseline	Incidence of Adverse Events post baseline	3 Years