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)

Navidea Biopharmaceuticals11 sites in 1 country76 target enrollmentMarch 2013

ConditionsMild Cognitive Impairment

Interventions[18F]NAV4694

Overview

Phase: Phase 2
Intervention: [18F]NAV4694
Conditions: Mild Cognitive Impairment
Sponsor: Navidea Biopharmaceuticals
Enrollment: 76
Locations: 11
Primary Endpoint: Incidence of Mild Cognitive Impairment Progression to Alzheimer's Disease
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2013

End Date

November 2, 2017

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Navidea Biopharmaceuticals

Responsible Party

Sponsor

Eligibility 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)

Arms & Interventions

[18F]NAV4694

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

Intervention: [18F]NAV4694

Outcomes

Primary Outcomes

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 Outcomes

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 30 Months Compared to Baseline(30 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(36 months)
Incidence of Adverse Events Post Baseline(3 Years)
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)